Trial Outcomes & Findings for Pilot Study of an NTproBNP Guided Strategy of Cardioprotection (NCT NCT04737265)
NCT ID: NCT04737265
Last Updated: 2026-06-15
Results Overview
Number of patients that had at least one targeted AE of grade 3 or higher at any time on study.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
108 participants
Primary outcome timeframe
12 months
Results posted on
2026-06-15
Participant Flow
Enrollment took place from March 2021 to October 2023 from outpatient oncology practices at multiple locations within the University of Pennsylvania Health System and at City of Hope Cancer Center.
108 individuals provided consent. 7 individuals were not randomized due to 1 of the following reasons: voluntary withdrawal, change in chemotherapy regimen, or uncontrolled blood pressure. 101 patients were randomized and started the trial.
Participant milestones
| Measure |
Biomarker Guided Arm
NTproBNP will be monitored serially prior to start of anthracycline based chemotherapy, at each cycle of anthracycline based chemotherapy, and at 3 month intervals for a total of 12 months. NTproBNP above the upper limit of normal triggers initiation and titration of neurohormonal therapy per protocol algorithm.
Clinical, echocardiographic, and biomarker data will be collected on all patients at baseline and at standardized intervals at 3, 6, 9, and 12 months following initiation of anthracycline chemotherapy.
|
Usual Care
NTproBNP will not be monitored while patients are on study unless clinically indicated. Clinical, echocardiographic, and biomarker data will be collected on all patients at baseline and at standardized intervals at 3, 6, 9, and 12 months following initiation of anthracycline chemotherapy. Biomarker data will also be collected at each cycle of anthracycline chemotherapy.
|
|---|---|---|
|
Overall Study
STARTED
|
51
|
50
|
|
Overall Study
3 Month
|
48
|
49
|
|
Overall Study
6 Month
|
48
|
45
|
|
Overall Study
9 Month
|
48
|
44
|
|
Overall Study
COMPLETED
|
47
|
42
|
|
Overall Study
NOT COMPLETED
|
4
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pilot Study of an NTproBNP Guided Strategy of Cardioprotection
Baseline characteristics by cohort
| Measure |
Biomarker Guided Arm
n=50 Participants
NTproBNP will be monitored serially prior to start of anthracycline based chemotherapy, at each cycle of anthracycline based chemotherapy, and at 3 month intervals for a total of 12 months. NTproBNP above the upper limit of normal triggers initiation and titration of neurohormonal therapy per protocol algorithm.
Clinical, echocardiographic, and biomarker data will be collected on all patients at baseline and at standardized intervals at 3, 6, 9, and 12 months following initiation of Anthracycline chemotherapy.
|
Usual Care
n=50 Participants
NTproBNP will not be monitored while patients are on study unless clinically indicated. Clinical, echocardiographic, and biomarker data will be collected on all patients at baseline and at standardized intervals at 3, 6, 9, and 12 months following initiation of Anthracycline chemotherapy. Biomarker data will also be collected at each cycle of Anthracycline chemotherapy.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.5 years
STANDARD_DEVIATION 12.5 • n=20 Participants
|
50.0 years
STANDARD_DEVIATION 15.9 • n=20 Participants
|
52.2 years
STANDARD_DEVIATION 14.4 • n=40 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=20 Participants
|
44 Participants
n=20 Participants
|
86 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
14 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
6 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
50 Participants
n=20 Participants
|
44 Participants
n=20 Participants
|
94 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
10 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
10 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=20 Participants
|
39 Participants
n=20 Participants
|
77 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
|
Cancer Type
Breast Cancer
|
37 Participants
n=20 Participants
|
37 Participants
n=20 Participants
|
74 Participants
n=40 Participants
|
|
Cancer Type
Lymphoma
|
13 Participants
n=20 Participants
|
13 Participants
n=20 Participants
|
26 Participants
n=40 Participants
|
|
Systolic Blood Pressure
|
125 mmHg
n=20 Participants
|
119 mmHg
n=20 Participants
|
121 mmHg
n=40 Participants
|
|
Left Ventricular Ejection Fraction
|
59.1 %
n=20 Participants
|
57.9 %
n=20 Participants
|
58.6 %
n=40 Participants
|
|
Cardiovascular Risk Factors
Current and Prior Smokers
|
23 Participants
n=20 Participants
|
19 Participants
n=20 Participants
|
42 Participants
n=40 Participants
|
|
Cardiovascular Risk Factors
Diabetes
|
4 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
6 Participants
n=40 Participants
|
|
Cardiovascular Risk Factors
Hypertension
|
21 Participants
n=20 Participants
|
12 Participants
n=20 Participants
|
33 Participants
n=40 Participants
|
|
Cardiovascular Risk Factors
Coronary Disease
|
4 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
6 Participants
n=40 Participants
|
|
Cardiovascular Risk Factors
Hyperlipidemia
|
13 Participants
n=20 Participants
|
16 Participants
n=20 Participants
|
29 Participants
n=40 Participants
|
|
NTproBNP Concentration
|
69 pg/ml
n=20 Participants
|
54 pg/ml
n=20 Participants
|
64 pg/ml
n=40 Participants
|
|
Body Mass Index (BMI)
|
28.1 kg/m2
n=20 Participants
|
27.2 kg/m2
n=20 Participants
|
27.8 kg/m2
n=40 Participants
|
PRIMARY outcome
Timeframe: At baselinePopulation: We defined recruitment rate as the percent of patients approached about the study who consented to participate
percent of patients approached about the study who provided consent
Outcome measures
| Measure |
Intervention Arm Patients on Valsartan-Hydrochlorothiazide
Patients randomized to the intervention arm who initiated and/or titrated valsartan-hydrochlorothiazide for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Sacubitril-valsartan
Patients randomized to the intervention arm who initiated and/or titrated sacubitril-valsartan for NTproBNP elevation while on trial.
|
Biomarker Guided Arm
n=220 Participants
NTproBNP will be monitored serially prior to start of anthracycline based chemotherapy, at each cycle of anthracycline based chemotherapy, and at 3 month intervals for a total of 12 months. NTproBNP above the upper limit of normal triggers initiation and titration of neurohormonal therapy per protocol algorithm.
Clinical, echocardiographic, and biomarker data will be collected on all patients at baseline and at standardized intervals at 3, 6, 9, and 12 months following initiation of Anthracycline chemotherapy.
|
Usual Care
NTproBNP will not be monitored while patients are on study unless clinically indicated. Clinical, echocardiographic, and biomarker data will be collected on all patients at baseline and at standardized intervals at 3, 6, 9, and 12 months following initiation of Anthracycline chemotherapy. Biomarker data will also be collected at each cycle of Anthracycline chemotherapy.
|
Intervention Arm Patients on Lisinopril
Patients randomized to the intervention arm who initiated and/or titrated lisinopril for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Losartan
Patients randomized to the intervention arm who initiated and/or titrated losartan for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Irbesartan
Patients randomized to the intervention arm who initiated and/or titrated irbesartan for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Valsartan
Patients randomized to the intervention arm who initiated and/or titrated valsartan for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Spironolactone
Patients randomized to the intervention arm who initiated and/or titrated spironolactone for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Eplerenone
Patients randomized to the intervention arm who initiated and/or titrated eplerenone for NTproBNP elevation while on trial.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Recruitment Rate
|
—
|
—
|
108 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Through study completion (expected to be 1 year)Population: The analysis population for retention rate excludes those patients who died while on study.
percent of randomized patients who complete the study per protocol
Outcome measures
| Measure |
Intervention Arm Patients on Valsartan-Hydrochlorothiazide
Patients randomized to the intervention arm who initiated and/or titrated valsartan-hydrochlorothiazide for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Sacubitril-valsartan
Patients randomized to the intervention arm who initiated and/or titrated sacubitril-valsartan for NTproBNP elevation while on trial.
|
Biomarker Guided Arm
n=50 Participants
NTproBNP will be monitored serially prior to start of anthracycline based chemotherapy, at each cycle of anthracycline based chemotherapy, and at 3 month intervals for a total of 12 months. NTproBNP above the upper limit of normal triggers initiation and titration of neurohormonal therapy per protocol algorithm.
Clinical, echocardiographic, and biomarker data will be collected on all patients at baseline and at standardized intervals at 3, 6, 9, and 12 months following initiation of Anthracycline chemotherapy.
|
Usual Care
n=46 Participants
NTproBNP will not be monitored while patients are on study unless clinically indicated. Clinical, echocardiographic, and biomarker data will be collected on all patients at baseline and at standardized intervals at 3, 6, 9, and 12 months following initiation of Anthracycline chemotherapy. Biomarker data will also be collected at each cycle of Anthracycline chemotherapy.
|
Intervention Arm Patients on Lisinopril
Patients randomized to the intervention arm who initiated and/or titrated lisinopril for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Losartan
Patients randomized to the intervention arm who initiated and/or titrated losartan for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Irbesartan
Patients randomized to the intervention arm who initiated and/or titrated irbesartan for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Valsartan
Patients randomized to the intervention arm who initiated and/or titrated valsartan for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Spironolactone
Patients randomized to the intervention arm who initiated and/or titrated spironolactone for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Eplerenone
Patients randomized to the intervention arm who initiated and/or titrated eplerenone for NTproBNP elevation while on trial.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Retention Rate
|
—
|
—
|
47 Participants
|
42 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Through study completion (expected to be 1 year)Population: In total, 27 patients on the intervention arm experienced at least 1 NTproBNP elevation. Of these, 4 did not have any initiation or titration of neurohormonal medications at any point. The analysis population for compliance with study medications includes only those patients who initiated or titrated neurohormonal medications for NTproBNP elevation.
Compliance by Patient Reported Outcomes Information System (PROMIS) Scale v1.0 for patients in the biomarker guided arm initiated on heart failure medications. A higher PROMIS compliance score indicates better compliance with medications (score ranges from 9 - 45).
Outcome measures
| Measure |
Intervention Arm Patients on Valsartan-Hydrochlorothiazide
Patients randomized to the intervention arm who initiated and/or titrated valsartan-hydrochlorothiazide for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Sacubitril-valsartan
Patients randomized to the intervention arm who initiated and/or titrated sacubitril-valsartan for NTproBNP elevation while on trial.
|
Biomarker Guided Arm
n=23 Participants
NTproBNP will be monitored serially prior to start of anthracycline based chemotherapy, at each cycle of anthracycline based chemotherapy, and at 3 month intervals for a total of 12 months. NTproBNP above the upper limit of normal triggers initiation and titration of neurohormonal therapy per protocol algorithm.
Clinical, echocardiographic, and biomarker data will be collected on all patients at baseline and at standardized intervals at 3, 6, 9, and 12 months following initiation of Anthracycline chemotherapy.
|
Usual Care
NTproBNP will not be monitored while patients are on study unless clinically indicated. Clinical, echocardiographic, and biomarker data will be collected on all patients at baseline and at standardized intervals at 3, 6, 9, and 12 months following initiation of Anthracycline chemotherapy. Biomarker data will also be collected at each cycle of Anthracycline chemotherapy.
|
Intervention Arm Patients on Lisinopril
Patients randomized to the intervention arm who initiated and/or titrated lisinopril for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Losartan
Patients randomized to the intervention arm who initiated and/or titrated losartan for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Irbesartan
Patients randomized to the intervention arm who initiated and/or titrated irbesartan for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Valsartan
Patients randomized to the intervention arm who initiated and/or titrated valsartan for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Spironolactone
Patients randomized to the intervention arm who initiated and/or titrated spironolactone for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Eplerenone
Patients randomized to the intervention arm who initiated and/or titrated eplerenone for NTproBNP elevation while on trial.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Compliance Rate
|
—
|
—
|
31 score on a scale
Interval 17.0 to 33.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Through study completion (expected to be 1 year)Population: For this outcome measure, we consider only those patients randomized to the intervention arm who initiated and/or titrated at least one neurohormonal therapy for NTproBNP elevation on trial.
Maximum dose (mg) of neurohormonal antagonist therapy for participants in the intervention arm who initiated neurohormonal therapy for NTproBNP elevation across all study timepoints. Please note, due to numeric validation requirement, the max dose for combination drugs reported below is the max dose for the component in our algorithm (e.g. valsartan-hydrochlorothiazide is reported below as 325, which is the max dose of valsartan).
Outcome measures
| Measure |
Intervention Arm Patients on Valsartan-Hydrochlorothiazide
n=1 Participants
Patients randomized to the intervention arm who initiated and/or titrated valsartan-hydrochlorothiazide for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Sacubitril-valsartan
n=2 Participants
Patients randomized to the intervention arm who initiated and/or titrated sacubitril-valsartan for NTproBNP elevation while on trial.
|
Biomarker Guided Arm
n=9 Participants
NTproBNP will be monitored serially prior to start of anthracycline based chemotherapy, at each cycle of anthracycline based chemotherapy, and at 3 month intervals for a total of 12 months. NTproBNP above the upper limit of normal triggers initiation and titration of neurohormonal therapy per protocol algorithm.
Clinical, echocardiographic, and biomarker data will be collected on all patients at baseline and at standardized intervals at 3, 6, 9, and 12 months following initiation of Anthracycline chemotherapy.
|
Usual Care
n=5 Participants
NTproBNP will not be monitored while patients are on study unless clinically indicated. Clinical, echocardiographic, and biomarker data will be collected on all patients at baseline and at standardized intervals at 3, 6, 9, and 12 months following initiation of Anthracycline chemotherapy. Biomarker data will also be collected at each cycle of Anthracycline chemotherapy.
|
Intervention Arm Patients on Lisinopril
n=19 Participants
Patients randomized to the intervention arm who initiated and/or titrated lisinopril for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Losartan
n=4 Participants
Patients randomized to the intervention arm who initiated and/or titrated losartan for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Irbesartan
n=1 Participants
Patients randomized to the intervention arm who initiated and/or titrated irbesartan for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Valsartan
n=5 Participants
Patients randomized to the intervention arm who initiated and/or titrated valsartan for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Spironolactone
n=2 Participants
Patients randomized to the intervention arm who initiated and/or titrated spironolactone for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Eplerenone
n=5 Participants
Patients randomized to the intervention arm who initiated and/or titrated eplerenone for NTproBNP elevation while on trial.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Dose
|
320 mg
Interval 320.0 to 320.0
|
52 mg
Interval 52.0 to 52.0
|
12.5 mg
Interval 6.25 to 25.0
|
100 mg
Interval 50.0 to 125.0
|
6.25 mg
Interval 2.5 to 25.0
|
50 mg
Interval 25.0 to 100.0
|
75 mg
Interval 75.0 to 75.0
|
40 mg
Interval 40.0 to 73.0
|
25 mg
Interval 25.0 to 50.0
|
25 mg
Interval 25.0 to 50.0
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: 101 patients were randomized, but 1 withdrew immediately following randomization with no study procedures completed or data collected, so this individual is not included in the outcome reporting.
Number of patients that had at least one targeted AE of grade 3 or higher at any time on study.
Outcome measures
| Measure |
Intervention Arm Patients on Valsartan-Hydrochlorothiazide
Patients randomized to the intervention arm who initiated and/or titrated valsartan-hydrochlorothiazide for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Sacubitril-valsartan
Patients randomized to the intervention arm who initiated and/or titrated sacubitril-valsartan for NTproBNP elevation while on trial.
|
Biomarker Guided Arm
n=50 Participants
NTproBNP will be monitored serially prior to start of anthracycline based chemotherapy, at each cycle of anthracycline based chemotherapy, and at 3 month intervals for a total of 12 months. NTproBNP above the upper limit of normal triggers initiation and titration of neurohormonal therapy per protocol algorithm.
Clinical, echocardiographic, and biomarker data will be collected on all patients at baseline and at standardized intervals at 3, 6, 9, and 12 months following initiation of Anthracycline chemotherapy.
|
Usual Care
n=50 Participants
NTproBNP will not be monitored while patients are on study unless clinically indicated. Clinical, echocardiographic, and biomarker data will be collected on all patients at baseline and at standardized intervals at 3, 6, 9, and 12 months following initiation of Anthracycline chemotherapy. Biomarker data will also be collected at each cycle of Anthracycline chemotherapy.
|
Intervention Arm Patients on Lisinopril
Patients randomized to the intervention arm who initiated and/or titrated lisinopril for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Losartan
Patients randomized to the intervention arm who initiated and/or titrated losartan for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Irbesartan
Patients randomized to the intervention arm who initiated and/or titrated irbesartan for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Valsartan
Patients randomized to the intervention arm who initiated and/or titrated valsartan for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Spironolactone
Patients randomized to the intervention arm who initiated and/or titrated spironolactone for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Eplerenone
Patients randomized to the intervention arm who initiated and/or titrated eplerenone for NTproBNP elevation while on trial.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Incidence of Adverse Events
Number of particpants with a targeted AE (regardless of attribution)
|
—
|
—
|
23 Participants
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Incidence of Adverse Events
Number of participants with a targeted AE at least possibly related to the study intervention
|
—
|
—
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through study completion (1 year)Population: Randomized participants with baseline and at least one follow-up measure of NTproBNP.
Change in estimated core lab measured NTproBNP by group. GEE model adjusted for baseline values and time since anthracycline initiation, modeled with spline function. NTproBNP is a hormone released when the heart is under stress. Concentrations greater than 125 pg/ml are considered to be elevated.
Outcome measures
| Measure |
Intervention Arm Patients on Valsartan-Hydrochlorothiazide
Patients randomized to the intervention arm who initiated and/or titrated valsartan-hydrochlorothiazide for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Sacubitril-valsartan
Patients randomized to the intervention arm who initiated and/or titrated sacubitril-valsartan for NTproBNP elevation while on trial.
|
Biomarker Guided Arm
n=49 Participants
NTproBNP will be monitored serially prior to start of anthracycline based chemotherapy, at each cycle of anthracycline based chemotherapy, and at 3 month intervals for a total of 12 months. NTproBNP above the upper limit of normal triggers initiation and titration of neurohormonal therapy per protocol algorithm.
Clinical, echocardiographic, and biomarker data will be collected on all patients at baseline and at standardized intervals at 3, 6, 9, and 12 months following initiation of Anthracycline chemotherapy.
|
Usual Care
n=48 Participants
NTproBNP will not be monitored while patients are on study unless clinically indicated. Clinical, echocardiographic, and biomarker data will be collected on all patients at baseline and at standardized intervals at 3, 6, 9, and 12 months following initiation of Anthracycline chemotherapy. Biomarker data will also be collected at each cycle of Anthracycline chemotherapy.
|
Intervention Arm Patients on Lisinopril
Patients randomized to the intervention arm who initiated and/or titrated lisinopril for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Losartan
Patients randomized to the intervention arm who initiated and/or titrated losartan for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Irbesartan
Patients randomized to the intervention arm who initiated and/or titrated irbesartan for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Valsartan
Patients randomized to the intervention arm who initiated and/or titrated valsartan for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Spironolactone
Patients randomized to the intervention arm who initiated and/or titrated spironolactone for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Eplerenone
Patients randomized to the intervention arm who initiated and/or titrated eplerenone for NTproBNP elevation while on trial.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change in NTproBNP
9 months
|
—
|
—
|
0.49 log2 transformed (pg/ml)
Interval 0.22 to 0.77
|
0.73 log2 transformed (pg/ml)
Interval 0.5 to 0.97
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in NTproBNP
2 weeks
|
—
|
—
|
.06 log2 transformed (pg/ml)
Interval -0.26 to 0.37
|
.48 log2 transformed (pg/ml)
Interval 0.2 to 0.76
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in NTproBNP
3 months
|
—
|
—
|
.72 log2 transformed (pg/ml)
Interval 0.36 to 1.07
|
0.57 log2 transformed (pg/ml)
Interval 0.3 to 0.85
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in NTproBNP
6 months
|
—
|
—
|
0.57 log2 transformed (pg/ml)
Interval 0.21 to 0.94
|
0.73 log2 transformed (pg/ml)
Interval 0.47 to 0.99
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in NTproBNP
12 months
|
—
|
—
|
0.56 log2 transformed (pg/ml)
Interval 0.27 to 0.85
|
0.62 log2 transformed (pg/ml)
Interval 0.29 to 0.95
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Patients were included in the echocardiogram analysis if they had a baseline echocardiogram and at least 1 follow-up echocardiogram.
Change in core-lab quantitated LVEF by echocardiogram from baseline. GEE model adjusted for baseline values and time since anthracycline initiation, modeled with spline function. LVEF is a measurement of how much blood the heart pumps out with each beat. It is calculated by dividing the volume of blood ejected with each beat divided the volume of blood in the heart, multiplied by 100 and reported as a percentage. An LVEF of less than 50% is considered abnormal.
Outcome measures
| Measure |
Intervention Arm Patients on Valsartan-Hydrochlorothiazide
Patients randomized to the intervention arm who initiated and/or titrated valsartan-hydrochlorothiazide for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Sacubitril-valsartan
Patients randomized to the intervention arm who initiated and/or titrated sacubitril-valsartan for NTproBNP elevation while on trial.
|
Biomarker Guided Arm
n=45 Participants
NTproBNP will be monitored serially prior to start of anthracycline based chemotherapy, at each cycle of anthracycline based chemotherapy, and at 3 month intervals for a total of 12 months. NTproBNP above the upper limit of normal triggers initiation and titration of neurohormonal therapy per protocol algorithm.
Clinical, echocardiographic, and biomarker data will be collected on all patients at baseline and at standardized intervals at 3, 6, 9, and 12 months following initiation of Anthracycline chemotherapy.
|
Usual Care
n=47 Participants
NTproBNP will not be monitored while patients are on study unless clinically indicated. Clinical, echocardiographic, and biomarker data will be collected on all patients at baseline and at standardized intervals at 3, 6, 9, and 12 months following initiation of Anthracycline chemotherapy. Biomarker data will also be collected at each cycle of Anthracycline chemotherapy.
|
Intervention Arm Patients on Lisinopril
Patients randomized to the intervention arm who initiated and/or titrated lisinopril for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Losartan
Patients randomized to the intervention arm who initiated and/or titrated losartan for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Irbesartan
Patients randomized to the intervention arm who initiated and/or titrated irbesartan for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Valsartan
Patients randomized to the intervention arm who initiated and/or titrated valsartan for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Spironolactone
Patients randomized to the intervention arm who initiated and/or titrated spironolactone for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Eplerenone
Patients randomized to the intervention arm who initiated and/or titrated eplerenone for NTproBNP elevation while on trial.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Left Ventricular Ejection Fraction (LVEF)
3 month
|
—
|
—
|
0.9 percentage
Interval -0.4 to 2.1
|
-1.2 percentage
Interval -2.0 to -0.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Left Ventricular Ejection Fraction (LVEF)
6 month
|
—
|
—
|
0.9 percentage
Interval -0.2 to 2.0
|
-0.2 percentage
Interval -1.0 to 0.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Left Ventricular Ejection Fraction (LVEF)
9 month
|
—
|
—
|
0.7 percentage
Interval -0.4 to 1.8
|
0.3 percentage
Interval -0.6 to 1.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Left Ventricular Ejection Fraction (LVEF)
12 month
|
—
|
—
|
0.5 percentage
Interval -0.6 to 1.5
|
0.4 percentage
Interval -0.6 to 1.4
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Patients were included in analysis if they had a baseline echocardiogram and at least 1 follow-up echocardiogram.
Incidence of cardiotoxicity defined as LVEF decline of at least 10% to less than 50%
Outcome measures
| Measure |
Intervention Arm Patients on Valsartan-Hydrochlorothiazide
Patients randomized to the intervention arm who initiated and/or titrated valsartan-hydrochlorothiazide for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Sacubitril-valsartan
Patients randomized to the intervention arm who initiated and/or titrated sacubitril-valsartan for NTproBNP elevation while on trial.
|
Biomarker Guided Arm
n=45 Participants
NTproBNP will be monitored serially prior to start of anthracycline based chemotherapy, at each cycle of anthracycline based chemotherapy, and at 3 month intervals for a total of 12 months. NTproBNP above the upper limit of normal triggers initiation and titration of neurohormonal therapy per protocol algorithm.
Clinical, echocardiographic, and biomarker data will be collected on all patients at baseline and at standardized intervals at 3, 6, 9, and 12 months following initiation of Anthracycline chemotherapy.
|
Usual Care
n=47 Participants
NTproBNP will not be monitored while patients are on study unless clinically indicated. Clinical, echocardiographic, and biomarker data will be collected on all patients at baseline and at standardized intervals at 3, 6, 9, and 12 months following initiation of Anthracycline chemotherapy. Biomarker data will also be collected at each cycle of Anthracycline chemotherapy.
|
Intervention Arm Patients on Lisinopril
Patients randomized to the intervention arm who initiated and/or titrated lisinopril for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Losartan
Patients randomized to the intervention arm who initiated and/or titrated losartan for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Irbesartan
Patients randomized to the intervention arm who initiated and/or titrated irbesartan for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Valsartan
Patients randomized to the intervention arm who initiated and/or titrated valsartan for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Spironolactone
Patients randomized to the intervention arm who initiated and/or titrated spironolactone for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Eplerenone
Patients randomized to the intervention arm who initiated and/or titrated eplerenone for NTproBNP elevation while on trial.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Incidence of Cardiotoxicity
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 101 patients were randomized, but 1 withdrew immediately following randomization with no study procedures completed or data collected, so this individual is not included in the outcome reporting.
Incidence of new or worsened clinical heart failure, defined as urgent or new office or emergency department visit or hospitalization for adjudicated heart failure.
Outcome measures
| Measure |
Intervention Arm Patients on Valsartan-Hydrochlorothiazide
Patients randomized to the intervention arm who initiated and/or titrated valsartan-hydrochlorothiazide for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Sacubitril-valsartan
Patients randomized to the intervention arm who initiated and/or titrated sacubitril-valsartan for NTproBNP elevation while on trial.
|
Biomarker Guided Arm
n=50 Participants
NTproBNP will be monitored serially prior to start of anthracycline based chemotherapy, at each cycle of anthracycline based chemotherapy, and at 3 month intervals for a total of 12 months. NTproBNP above the upper limit of normal triggers initiation and titration of neurohormonal therapy per protocol algorithm.
Clinical, echocardiographic, and biomarker data will be collected on all patients at baseline and at standardized intervals at 3, 6, 9, and 12 months following initiation of Anthracycline chemotherapy.
|
Usual Care
n=50 Participants
NTproBNP will not be monitored while patients are on study unless clinically indicated. Clinical, echocardiographic, and biomarker data will be collected on all patients at baseline and at standardized intervals at 3, 6, 9, and 12 months following initiation of Anthracycline chemotherapy. Biomarker data will also be collected at each cycle of Anthracycline chemotherapy.
|
Intervention Arm Patients on Lisinopril
Patients randomized to the intervention arm who initiated and/or titrated lisinopril for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Losartan
Patients randomized to the intervention arm who initiated and/or titrated losartan for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Irbesartan
Patients randomized to the intervention arm who initiated and/or titrated irbesartan for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Valsartan
Patients randomized to the intervention arm who initiated and/or titrated valsartan for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Spironolactone
Patients randomized to the intervention arm who initiated and/or titrated spironolactone for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Eplerenone
Patients randomized to the intervention arm who initiated and/or titrated eplerenone for NTproBNP elevation while on trial.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Incidence of Heart Failure (HF)
|
—
|
—
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Through study completion (expected to be 1 year)Population: 101 patients were randomized, but 1 withdrew immediately following randomization with no study procedures completed or data collected, so this individual is not included in the outcome reporting.
Frequency of cancer treatment interruptions (holds or early discontinuations)
Outcome measures
| Measure |
Intervention Arm Patients on Valsartan-Hydrochlorothiazide
Patients randomized to the intervention arm who initiated and/or titrated valsartan-hydrochlorothiazide for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Sacubitril-valsartan
Patients randomized to the intervention arm who initiated and/or titrated sacubitril-valsartan for NTproBNP elevation while on trial.
|
Biomarker Guided Arm
n=50 Participants
NTproBNP will be monitored serially prior to start of anthracycline based chemotherapy, at each cycle of anthracycline based chemotherapy, and at 3 month intervals for a total of 12 months. NTproBNP above the upper limit of normal triggers initiation and titration of neurohormonal therapy per protocol algorithm.
Clinical, echocardiographic, and biomarker data will be collected on all patients at baseline and at standardized intervals at 3, 6, 9, and 12 months following initiation of Anthracycline chemotherapy.
|
Usual Care
n=50 Participants
NTproBNP will not be monitored while patients are on study unless clinically indicated. Clinical, echocardiographic, and biomarker data will be collected on all patients at baseline and at standardized intervals at 3, 6, 9, and 12 months following initiation of Anthracycline chemotherapy. Biomarker data will also be collected at each cycle of Anthracycline chemotherapy.
|
Intervention Arm Patients on Lisinopril
Patients randomized to the intervention arm who initiated and/or titrated lisinopril for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Losartan
Patients randomized to the intervention arm who initiated and/or titrated losartan for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Irbesartan
Patients randomized to the intervention arm who initiated and/or titrated irbesartan for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Valsartan
Patients randomized to the intervention arm who initiated and/or titrated valsartan for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Spironolactone
Patients randomized to the intervention arm who initiated and/or titrated spironolactone for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Eplerenone
Patients randomized to the intervention arm who initiated and/or titrated eplerenone for NTproBNP elevation while on trial.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Frequency of Cancer Treatment Interruptions
Interuptions due to cardiotoxicity
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Frequency of Cancer Treatment Interruptions
Interruptions due to study intervention
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: Patients were included in the echocardiogram analysis if they had a baseline echocardiogram and at least 1 follow-up echocardiogram.
GEE model of change in core lab measured E/e'. E/e' is a measure of diastolic function derived from the ratio of the pulse wave Doppler interrogations of the mitral inflow at the mitral valve leaflet tips and at the lateral and septal mitral annulus via tissue Doppler imaging. This measure provided insight into myocardial relaxation, preload, and left ventricular filling pressures, with values \> 14 indicative of elevated filling pressure. GEE model is adjusted for baseline values and time since anthracycline initiation, modeled with spline function.
Outcome measures
| Measure |
Intervention Arm Patients on Valsartan-Hydrochlorothiazide
Patients randomized to the intervention arm who initiated and/or titrated valsartan-hydrochlorothiazide for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Sacubitril-valsartan
Patients randomized to the intervention arm who initiated and/or titrated sacubitril-valsartan for NTproBNP elevation while on trial.
|
Biomarker Guided Arm
n=45 Participants
NTproBNP will be monitored serially prior to start of anthracycline based chemotherapy, at each cycle of anthracycline based chemotherapy, and at 3 month intervals for a total of 12 months. NTproBNP above the upper limit of normal triggers initiation and titration of neurohormonal therapy per protocol algorithm.
Clinical, echocardiographic, and biomarker data will be collected on all patients at baseline and at standardized intervals at 3, 6, 9, and 12 months following initiation of Anthracycline chemotherapy.
|
Usual Care
n=47 Participants
NTproBNP will not be monitored while patients are on study unless clinically indicated. Clinical, echocardiographic, and biomarker data will be collected on all patients at baseline and at standardized intervals at 3, 6, 9, and 12 months following initiation of Anthracycline chemotherapy. Biomarker data will also be collected at each cycle of Anthracycline chemotherapy.
|
Intervention Arm Patients on Lisinopril
Patients randomized to the intervention arm who initiated and/or titrated lisinopril for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Losartan
Patients randomized to the intervention arm who initiated and/or titrated losartan for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Irbesartan
Patients randomized to the intervention arm who initiated and/or titrated irbesartan for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Valsartan
Patients randomized to the intervention arm who initiated and/or titrated valsartan for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Spironolactone
Patients randomized to the intervention arm who initiated and/or titrated spironolactone for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Eplerenone
Patients randomized to the intervention arm who initiated and/or titrated eplerenone for NTproBNP elevation while on trial.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Diastolic Function on Echo
3 months
|
—
|
—
|
0.2 ratio
Interval -0.5 to 1.0
|
0.9 ratio
Interval 0.0 to 1.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Diastolic Function on Echo
6 months
|
—
|
—
|
0.2 ratio
Interval -0.5 to 1.0
|
0.6 ratio
Interval -0.2 to 1.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Diastolic Function on Echo
9 months
|
—
|
—
|
0.1 ratio
Interval -0.6 to 0.7
|
0.1 ratio
Interval -0.5 to 0.6
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Diastolic Function on Echo
12 months
|
—
|
—
|
0.9 ratio
Interval -1.0 to 2.7
|
-0.1 ratio
Interval -0.6 to 0.4
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: Patients were included in the echocardiogram analysis if they had a baseline echocardiogram and at least 1 follow-up echocardiogram.
Change in core-lab quantitated estimated global longitudinal strain by echocardiogram. GEE model adjusted for baseline values and time since anthracycline initiation, modeled with spline function. Global longitudinal strain (GLS, %) averaged from 3 apical views (left ventricular apical 4-chamber, 2-chamber, and 3-chamber) was obtained using speckle-tracking technology using Tomtec Imaging Systems. GLS is a more sensitive measure of cardiac function, with values greater than -16% (e.g., -15%) for GLS associated with worse outcomes.
Outcome measures
| Measure |
Intervention Arm Patients on Valsartan-Hydrochlorothiazide
Patients randomized to the intervention arm who initiated and/or titrated valsartan-hydrochlorothiazide for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Sacubitril-valsartan
Patients randomized to the intervention arm who initiated and/or titrated sacubitril-valsartan for NTproBNP elevation while on trial.
|
Biomarker Guided Arm
n=45 Participants
NTproBNP will be monitored serially prior to start of anthracycline based chemotherapy, at each cycle of anthracycline based chemotherapy, and at 3 month intervals for a total of 12 months. NTproBNP above the upper limit of normal triggers initiation and titration of neurohormonal therapy per protocol algorithm.
Clinical, echocardiographic, and biomarker data will be collected on all patients at baseline and at standardized intervals at 3, 6, 9, and 12 months following initiation of Anthracycline chemotherapy.
|
Usual Care
n=47 Participants
NTproBNP will not be monitored while patients are on study unless clinically indicated. Clinical, echocardiographic, and biomarker data will be collected on all patients at baseline and at standardized intervals at 3, 6, 9, and 12 months following initiation of Anthracycline chemotherapy. Biomarker data will also be collected at each cycle of Anthracycline chemotherapy.
|
Intervention Arm Patients on Lisinopril
Patients randomized to the intervention arm who initiated and/or titrated lisinopril for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Losartan
Patients randomized to the intervention arm who initiated and/or titrated losartan for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Irbesartan
Patients randomized to the intervention arm who initiated and/or titrated irbesartan for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Valsartan
Patients randomized to the intervention arm who initiated and/or titrated valsartan for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Spironolactone
Patients randomized to the intervention arm who initiated and/or titrated spironolactone for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Eplerenone
Patients randomized to the intervention arm who initiated and/or titrated eplerenone for NTproBNP elevation while on trial.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Longitudinal Strain
3 months
|
—
|
—
|
0 percentage points
Interval -0.6 to 0.6
|
0.6 percentage points
Interval -0.1 to 1.2
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Longitudinal Strain
6 months
|
—
|
—
|
0.1 percentage points
Interval -0.5 to 0.8
|
0.6 percentage points
Interval 0.0 to 1.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Longitudinal Strain
9 months
|
—
|
—
|
0.2 percentage points
Interval -0.4 to 0.8
|
0.3 percentage points
Interval -0.4 to 1.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Longitudinal Strain
12 months
|
—
|
—
|
0.9 percentage points
Interval 0.3 to 1.4
|
0.6 percentage points
Interval 0.0 to 1.2
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: Patients were included in the echocardiogram analysis if they had a baseline echocardiogram and at least 1 follow-up echocardiogram.
Change in core-lab measured circumferential strain by echocardiogram. GEE model adjusted for baseline values and time since anthracycline initiation, modeled with spline function. Circumferential strain (%) from the short axis view (mid left ventricle) was obtained using speckle-tracking technology using Tomtec Imaging Systems. Circumferential strain is a more sensitive measure of cardiac function, with values or greater than -20% (e.g., -19%) associated with worse outcomes.
Outcome measures
| Measure |
Intervention Arm Patients on Valsartan-Hydrochlorothiazide
Patients randomized to the intervention arm who initiated and/or titrated valsartan-hydrochlorothiazide for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Sacubitril-valsartan
Patients randomized to the intervention arm who initiated and/or titrated sacubitril-valsartan for NTproBNP elevation while on trial.
|
Biomarker Guided Arm
n=45 Participants
NTproBNP will be monitored serially prior to start of anthracycline based chemotherapy, at each cycle of anthracycline based chemotherapy, and at 3 month intervals for a total of 12 months. NTproBNP above the upper limit of normal triggers initiation and titration of neurohormonal therapy per protocol algorithm.
Clinical, echocardiographic, and biomarker data will be collected on all patients at baseline and at standardized intervals at 3, 6, 9, and 12 months following initiation of Anthracycline chemotherapy.
|
Usual Care
n=47 Participants
NTproBNP will not be monitored while patients are on study unless clinically indicated. Clinical, echocardiographic, and biomarker data will be collected on all patients at baseline and at standardized intervals at 3, 6, 9, and 12 months following initiation of Anthracycline chemotherapy. Biomarker data will also be collected at each cycle of Anthracycline chemotherapy.
|
Intervention Arm Patients on Lisinopril
Patients randomized to the intervention arm who initiated and/or titrated lisinopril for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Losartan
Patients randomized to the intervention arm who initiated and/or titrated losartan for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Irbesartan
Patients randomized to the intervention arm who initiated and/or titrated irbesartan for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Valsartan
Patients randomized to the intervention arm who initiated and/or titrated valsartan for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Spironolactone
Patients randomized to the intervention arm who initiated and/or titrated spironolactone for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Eplerenone
Patients randomized to the intervention arm who initiated and/or titrated eplerenone for NTproBNP elevation while on trial.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change in Circumferential Strain
3 months
|
—
|
—
|
0.4 percentage points
Interval -1.2 to 2.0
|
1.5 percentage points
Interval 0.1 to 2.9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Circumferential Strain
6 months
|
—
|
—
|
0.5 percentage points
Interval -1.1 to 2.1
|
1.3 percentage points
Interval -0.1 to 2.7
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Circumferential Strain
9 months
|
—
|
—
|
1.9 percentage points
Interval 0.3 to 3.5
|
1.9 percentage points
Interval 0.6 to 3.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Circumferential Strain
12 months
|
—
|
—
|
0.6 percentage points
Interval -0.8 to 2.0
|
0.8 percentage points
Interval -0.5 to 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: 101 patients were randomized, but 1 withdrew immediately following randomization with no study procedures completed or data collected, so this individual is not included in the outcome reporting.
We utilized the Patient Reported Outcomes Information System (PROMIS) Fatigue T-Score. A PROMIS Fatigue T-score of 50 indicates the population mean with a standard deviation of 10. A higher score corresponds to higher levels of reported fatigue.
Outcome measures
| Measure |
Intervention Arm Patients on Valsartan-Hydrochlorothiazide
Patients randomized to the intervention arm who initiated and/or titrated valsartan-hydrochlorothiazide for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Sacubitril-valsartan
Patients randomized to the intervention arm who initiated and/or titrated sacubitril-valsartan for NTproBNP elevation while on trial.
|
Biomarker Guided Arm
n=50 Participants
NTproBNP will be monitored serially prior to start of anthracycline based chemotherapy, at each cycle of anthracycline based chemotherapy, and at 3 month intervals for a total of 12 months. NTproBNP above the upper limit of normal triggers initiation and titration of neurohormonal therapy per protocol algorithm.
Clinical, echocardiographic, and biomarker data will be collected on all patients at baseline and at standardized intervals at 3, 6, 9, and 12 months following initiation of Anthracycline chemotherapy.
|
Usual Care
n=50 Participants
NTproBNP will not be monitored while patients are on study unless clinically indicated. Clinical, echocardiographic, and biomarker data will be collected on all patients at baseline and at standardized intervals at 3, 6, 9, and 12 months following initiation of Anthracycline chemotherapy. Biomarker data will also be collected at each cycle of Anthracycline chemotherapy.
|
Intervention Arm Patients on Lisinopril
Patients randomized to the intervention arm who initiated and/or titrated lisinopril for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Losartan
Patients randomized to the intervention arm who initiated and/or titrated losartan for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Irbesartan
Patients randomized to the intervention arm who initiated and/or titrated irbesartan for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Valsartan
Patients randomized to the intervention arm who initiated and/or titrated valsartan for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Spironolactone
Patients randomized to the intervention arm who initiated and/or titrated spironolactone for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Eplerenone
Patients randomized to the intervention arm who initiated and/or titrated eplerenone for NTproBNP elevation while on trial.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Patient Reported Fatigue
12 Months
|
—
|
—
|
48 T-score
Standard Deviation 9
|
54 T-score
Standard Deviation 9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Reported Fatigue
Baseline
|
—
|
—
|
51 T-score
Standard Deviation 8
|
54 T-score
Standard Deviation 9
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Reported Fatigue
3 Months
|
—
|
—
|
55 T-score
Standard Deviation 9
|
56 T-score
Standard Deviation 10
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Reported Fatigue
6 Months
|
—
|
—
|
50 T-score
Standard Deviation 10
|
53 T-score
Standard Deviation 10
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Reported Fatigue
9 Months
|
—
|
—
|
50 T-score
Standard Deviation 9
|
54 T-score
Standard Deviation 10
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: 101 patients were randomized, but 1 withdrew immediately following randomization with no study procedures completed or data collected, so this individual is not included in the outcome reporting.
We utilized the Patient Reported Outcomes Information System (PROMIS) Global Health T-score. PROMIS v1.2 Global Health was used to assess physical and mental health. A T-Score of 50 indicates the population mean with a standard deviation of 10. Higher scores indicate better global physical or mental health.
Outcome measures
| Measure |
Intervention Arm Patients on Valsartan-Hydrochlorothiazide
Patients randomized to the intervention arm who initiated and/or titrated valsartan-hydrochlorothiazide for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Sacubitril-valsartan
Patients randomized to the intervention arm who initiated and/or titrated sacubitril-valsartan for NTproBNP elevation while on trial.
|
Biomarker Guided Arm
n=50 Participants
NTproBNP will be monitored serially prior to start of anthracycline based chemotherapy, at each cycle of anthracycline based chemotherapy, and at 3 month intervals for a total of 12 months. NTproBNP above the upper limit of normal triggers initiation and titration of neurohormonal therapy per protocol algorithm.
Clinical, echocardiographic, and biomarker data will be collected on all patients at baseline and at standardized intervals at 3, 6, 9, and 12 months following initiation of Anthracycline chemotherapy.
|
Usual Care
n=50 Participants
NTproBNP will not be monitored while patients are on study unless clinically indicated. Clinical, echocardiographic, and biomarker data will be collected on all patients at baseline and at standardized intervals at 3, 6, 9, and 12 months following initiation of Anthracycline chemotherapy. Biomarker data will also be collected at each cycle of Anthracycline chemotherapy.
|
Intervention Arm Patients on Lisinopril
Patients randomized to the intervention arm who initiated and/or titrated lisinopril for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Losartan
Patients randomized to the intervention arm who initiated and/or titrated losartan for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Irbesartan
Patients randomized to the intervention arm who initiated and/or titrated irbesartan for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Valsartan
Patients randomized to the intervention arm who initiated and/or titrated valsartan for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Spironolactone
Patients randomized to the intervention arm who initiated and/or titrated spironolactone for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Eplerenone
Patients randomized to the intervention arm who initiated and/or titrated eplerenone for NTproBNP elevation while on trial.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Patient Reported Quality of Life
Mental Health Baseline
|
—
|
—
|
49 T-score
Standard Deviation 8
|
48 T-score
Standard Deviation 10
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Reported Quality of Life
Mental Health 3 Months
|
—
|
—
|
48 T-score
Standard Deviation 8
|
48 T-score
Standard Deviation 10
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Reported Quality of Life
Mental Health 6 Months
|
—
|
—
|
48 T-score
Standard Deviation 8
|
47 T-score
Standard Deviation 8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Reported Quality of Life
Mental Health 9 Months
|
—
|
—
|
50 T-score
Standard Deviation 7
|
48 T-score
Standard Deviation 10
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Reported Quality of Life
Mental Health 12 Months
|
—
|
—
|
49 T-score
Standard Deviation 9
|
48 T-score
Standard Deviation 11
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Reported Quality of Life
Physical Health Baseline
|
—
|
—
|
48 T-score
Standard Deviation 9
|
46 T-score
Standard Deviation 8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Reported Quality of Life
Physical Health 3 Months
|
—
|
—
|
45 T-score
Standard Deviation 7
|
44 T-score
Standard Deviation 10
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Reported Quality of Life
Physical Health 9 Months
|
—
|
—
|
49 T-score
Standard Deviation 7
|
45 T-score
Standard Deviation 8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Reported Quality of Life
Physical Health 12 Months
|
—
|
—
|
50 T-score
Standard Deviation 9
|
47 T-score
Standard Deviation 10
|
—
|
—
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: 101 patients were randomized, but 1 withdrew immediately following randomization with no study procedures completed or data collected, so this individual is not included in the outcome reporting.
NCI Patient Reported Outcomes - Common Terms and Criteria for Adverse Events (PRO CTCAE) was used to ascertain presence of 7 symptoms (Shortness of Breath, Cough, Fatigue, Dizziness, Chest Pain, Palpitations, Limb Swelling).
Outcome measures
| Measure |
Intervention Arm Patients on Valsartan-Hydrochlorothiazide
Patients randomized to the intervention arm who initiated and/or titrated valsartan-hydrochlorothiazide for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Sacubitril-valsartan
Patients randomized to the intervention arm who initiated and/or titrated sacubitril-valsartan for NTproBNP elevation while on trial.
|
Biomarker Guided Arm
n=50 Participants
NTproBNP will be monitored serially prior to start of anthracycline based chemotherapy, at each cycle of anthracycline based chemotherapy, and at 3 month intervals for a total of 12 months. NTproBNP above the upper limit of normal triggers initiation and titration of neurohormonal therapy per protocol algorithm.
Clinical, echocardiographic, and biomarker data will be collected on all patients at baseline and at standardized intervals at 3, 6, 9, and 12 months following initiation of Anthracycline chemotherapy.
|
Usual Care
n=50 Participants
NTproBNP will not be monitored while patients are on study unless clinically indicated. Clinical, echocardiographic, and biomarker data will be collected on all patients at baseline and at standardized intervals at 3, 6, 9, and 12 months following initiation of Anthracycline chemotherapy. Biomarker data will also be collected at each cycle of Anthracycline chemotherapy.
|
Intervention Arm Patients on Lisinopril
Patients randomized to the intervention arm who initiated and/or titrated lisinopril for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Losartan
Patients randomized to the intervention arm who initiated and/or titrated losartan for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Irbesartan
Patients randomized to the intervention arm who initiated and/or titrated irbesartan for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Valsartan
Patients randomized to the intervention arm who initiated and/or titrated valsartan for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Spironolactone
Patients randomized to the intervention arm who initiated and/or titrated spironolactone for NTproBNP elevation while on trial.
|
Intervention Arm Patients on Eplerenone
Patients randomized to the intervention arm who initiated and/or titrated eplerenone for NTproBNP elevation while on trial.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Patient Reported Symptoms
6 Months - Chest Pain
|
—
|
—
|
2 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Reported Symptoms
9 Months - Chest Pain
|
—
|
—
|
6 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Reported Symptoms
12 Months - Chest Pain
|
—
|
—
|
3 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Reported Symptoms
Baseline - Palpitations
|
—
|
—
|
13 Participants
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Reported Symptoms
3 Months - Palpitations
|
—
|
—
|
17 Participants
|
19 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Reported Symptoms
6 Months - Palpitations
|
—
|
—
|
9 Participants
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Reported Symptoms
9 Months - Palpitations
|
—
|
—
|
9 Participants
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Reported Symptoms
12 Months - Cough
|
—
|
—
|
9 Participants
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Reported Symptoms
Baseline - Fatigue
|
—
|
—
|
34 Participants
|
41 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Reported Symptoms
3 Months - Fatigue
|
—
|
—
|
43 Participants
|
42 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Reported Symptoms
6 Months - Fatigue
|
—
|
—
|
33 Participants
|
35 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Reported Symptoms
9 Months - Fatigue
|
—
|
—
|
34 Participants
|
38 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Reported Symptoms
12 Months - Fatigue
|
—
|
—
|
30 Participants
|
34 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Reported Symptoms
Baseline - Dizziness
|
—
|
—
|
9 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Reported Symptoms
3 Months - Dizziness
|
—
|
—
|
16 Participants
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Reported Symptoms
6 Months - Dizziness
|
—
|
—
|
8 Participants
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Reported Symptoms
9 Months - Dizziness
|
—
|
—
|
10 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Reported Symptoms
12 Months - Dizziness
|
—
|
—
|
8 Participants
|
10 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Reported Symptoms
Baseline - Chest Pain
|
—
|
—
|
4 Participants
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Reported Symptoms
3 Months - Chest Pain
|
—
|
—
|
8 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Reported Symptoms
12 Months - Palpitations
|
—
|
—
|
8 Participants
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Reported Symptoms
Baseline - Swelling in Arms/Legs
|
—
|
—
|
4 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Reported Symptoms
3 Months - Swelling in Arms/Legs
|
—
|
—
|
6 Participants
|
12 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Reported Symptoms
6 Months - Swelling in Arms/Legs
|
—
|
—
|
7 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Reported Symptoms
9 Months - Swelling in Arms/Legs
|
—
|
—
|
11 Participants
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Reported Symptoms
12 Months - Swelling in Arms/Legs
|
—
|
—
|
10 Participants
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Reported Symptoms
Baseline - Shortness of Breath
|
—
|
—
|
15 Participants
|
22 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Reported Symptoms
3 Months - Shortness of Breath
|
—
|
—
|
24 Participants
|
19 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Reported Symptoms
6 Months - Shortness of Breath
|
—
|
—
|
11 Participants
|
18 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Reported Symptoms
9 Months - Shortness of Breath
|
—
|
—
|
15 Participants
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Reported Symptoms
12 Months - Shortness of Breath
|
—
|
—
|
11 Participants
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Reported Symptoms
Baseline - Cough
|
—
|
—
|
7 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Reported Symptoms
3 Months - Cough
|
—
|
—
|
14 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Reported Symptoms
6 Months - Cough
|
—
|
—
|
7 Participants
|
10 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Patient Reported Symptoms
9 Months - Cough
|
—
|
—
|
13 Participants
|
13 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Biomarker Guided Arm
Serious events: 9 serious events
Other events: 47 other events
Deaths: 0 deaths
Usual Care
Serious events: 14 serious events
Other events: 46 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Biomarker Guided Arm
n=50 participants at risk
NTproBNP will be monitored serially prior to start of anthracycline based chemotherapy, at each cycle of anthracycline based chemotherapy, and at 3 month intervals for a total of 12 months. NTproBNP above the upper limit of normal triggers initiation and titration of neurohormonal therapy per protocol algorithm.
Clinical, echocardiographic, and biomarker data will be collected on all patients at baseline and at standardized intervals at 3, 6, 9, and 12 months following initiation of Anthracycline chemotherapy.
|
Usual Care
n=50 participants at risk
NTproBNP will not be monitored while patients are on study unless clinically indicated. Clinical, echocardiographic, and biomarker data will be collected on all patients at baseline and at standardized intervals at 3, 6, 9, and 12 months following initiation of Anthracycline chemotherapy. Biomarker data will also be collected at each cycle of Anthracycline chemotherapy.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
2.0%
1/50 • From enrollment through end of follow-up (up to 12 months)
At each visit, grade 3 (CTCAEv5) and higher targeted events as well as events ending in death were collected by chart review and patient interview. Patients also completed 7 items from the NCI PROCTCAE at each visit. All SAEs and AEs collected per protocol and meeting reporting requirements are reported. 101 patients were randomized, but 1 withdrew immediately following randomization with no study procedures completed/data collected so this patient is not included in AE/SAE reporting.
|
0.00%
0/50 • From enrollment through end of follow-up (up to 12 months)
At each visit, grade 3 (CTCAEv5) and higher targeted events as well as events ending in death were collected by chart review and patient interview. Patients also completed 7 items from the NCI PROCTCAE at each visit. All SAEs and AEs collected per protocol and meeting reporting requirements are reported. 101 patients were randomized, but 1 withdrew immediately following randomization with no study procedures completed/data collected so this patient is not included in AE/SAE reporting.
|
|
General disorders
Disease Progression
|
0.00%
0/50 • From enrollment through end of follow-up (up to 12 months)
At each visit, grade 3 (CTCAEv5) and higher targeted events as well as events ending in death were collected by chart review and patient interview. Patients also completed 7 items from the NCI PROCTCAE at each visit. All SAEs and AEs collected per protocol and meeting reporting requirements are reported. 101 patients were randomized, but 1 withdrew immediately following randomization with no study procedures completed/data collected so this patient is not included in AE/SAE reporting.
|
4.0%
2/50 • From enrollment through end of follow-up (up to 12 months)
At each visit, grade 3 (CTCAEv5) and higher targeted events as well as events ending in death were collected by chart review and patient interview. Patients also completed 7 items from the NCI PROCTCAE at each visit. All SAEs and AEs collected per protocol and meeting reporting requirements are reported. 101 patients were randomized, but 1 withdrew immediately following randomization with no study procedures completed/data collected so this patient is not included in AE/SAE reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/50 • From enrollment through end of follow-up (up to 12 months)
At each visit, grade 3 (CTCAEv5) and higher targeted events as well as events ending in death were collected by chart review and patient interview. Patients also completed 7 items from the NCI PROCTCAE at each visit. All SAEs and AEs collected per protocol and meeting reporting requirements are reported. 101 patients were randomized, but 1 withdrew immediately following randomization with no study procedures completed/data collected so this patient is not included in AE/SAE reporting.
|
2.0%
1/50 • From enrollment through end of follow-up (up to 12 months)
At each visit, grade 3 (CTCAEv5) and higher targeted events as well as events ending in death were collected by chart review and patient interview. Patients also completed 7 items from the NCI PROCTCAE at each visit. All SAEs and AEs collected per protocol and meeting reporting requirements are reported. 101 patients were randomized, but 1 withdrew immediately following randomization with no study procedures completed/data collected so this patient is not included in AE/SAE reporting.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
2.0%
1/50 • From enrollment through end of follow-up (up to 12 months)
At each visit, grade 3 (CTCAEv5) and higher targeted events as well as events ending in death were collected by chart review and patient interview. Patients also completed 7 items from the NCI PROCTCAE at each visit. All SAEs and AEs collected per protocol and meeting reporting requirements are reported. 101 patients were randomized, but 1 withdrew immediately following randomization with no study procedures completed/data collected so this patient is not included in AE/SAE reporting.
|
0.00%
0/50 • From enrollment through end of follow-up (up to 12 months)
At each visit, grade 3 (CTCAEv5) and higher targeted events as well as events ending in death were collected by chart review and patient interview. Patients also completed 7 items from the NCI PROCTCAE at each visit. All SAEs and AEs collected per protocol and meeting reporting requirements are reported. 101 patients were randomized, but 1 withdrew immediately following randomization with no study procedures completed/data collected so this patient is not included in AE/SAE reporting.
|
|
Vascular disorders
Hypotension
|
2.0%
1/50 • From enrollment through end of follow-up (up to 12 months)
At each visit, grade 3 (CTCAEv5) and higher targeted events as well as events ending in death were collected by chart review and patient interview. Patients also completed 7 items from the NCI PROCTCAE at each visit. All SAEs and AEs collected per protocol and meeting reporting requirements are reported. 101 patients were randomized, but 1 withdrew immediately following randomization with no study procedures completed/data collected so this patient is not included in AE/SAE reporting.
|
0.00%
0/50 • From enrollment through end of follow-up (up to 12 months)
At each visit, grade 3 (CTCAEv5) and higher targeted events as well as events ending in death were collected by chart review and patient interview. Patients also completed 7 items from the NCI PROCTCAE at each visit. All SAEs and AEs collected per protocol and meeting reporting requirements are reported. 101 patients were randomized, but 1 withdrew immediately following randomization with no study procedures completed/data collected so this patient is not included in AE/SAE reporting.
|
|
Blood and lymphatic system disorders
Neutrophil Count Decreased
|
16.0%
8/50 • From enrollment through end of follow-up (up to 12 months)
At each visit, grade 3 (CTCAEv5) and higher targeted events as well as events ending in death were collected by chart review and patient interview. Patients also completed 7 items from the NCI PROCTCAE at each visit. All SAEs and AEs collected per protocol and meeting reporting requirements are reported. 101 patients were randomized, but 1 withdrew immediately following randomization with no study procedures completed/data collected so this patient is not included in AE/SAE reporting.
|
16.0%
8/50 • From enrollment through end of follow-up (up to 12 months)
At each visit, grade 3 (CTCAEv5) and higher targeted events as well as events ending in death were collected by chart review and patient interview. Patients also completed 7 items from the NCI PROCTCAE at each visit. All SAEs and AEs collected per protocol and meeting reporting requirements are reported. 101 patients were randomized, but 1 withdrew immediately following randomization with no study procedures completed/data collected so this patient is not included in AE/SAE reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/50 • From enrollment through end of follow-up (up to 12 months)
At each visit, grade 3 (CTCAEv5) and higher targeted events as well as events ending in death were collected by chart review and patient interview. Patients also completed 7 items from the NCI PROCTCAE at each visit. All SAEs and AEs collected per protocol and meeting reporting requirements are reported. 101 patients were randomized, but 1 withdrew immediately following randomization with no study procedures completed/data collected so this patient is not included in AE/SAE reporting.
|
4.0%
2/50 • From enrollment through end of follow-up (up to 12 months)
At each visit, grade 3 (CTCAEv5) and higher targeted events as well as events ending in death were collected by chart review and patient interview. Patients also completed 7 items from the NCI PROCTCAE at each visit. All SAEs and AEs collected per protocol and meeting reporting requirements are reported. 101 patients were randomized, but 1 withdrew immediately following randomization with no study procedures completed/data collected so this patient is not included in AE/SAE reporting.
|
|
Blood and lymphatic system disorders
White blood cell decreased
|
14.0%
7/50 • From enrollment through end of follow-up (up to 12 months)
At each visit, grade 3 (CTCAEv5) and higher targeted events as well as events ending in death were collected by chart review and patient interview. Patients also completed 7 items from the NCI PROCTCAE at each visit. All SAEs and AEs collected per protocol and meeting reporting requirements are reported. 101 patients were randomized, but 1 withdrew immediately following randomization with no study procedures completed/data collected so this patient is not included in AE/SAE reporting.
|
12.0%
6/50 • From enrollment through end of follow-up (up to 12 months)
At each visit, grade 3 (CTCAEv5) and higher targeted events as well as events ending in death were collected by chart review and patient interview. Patients also completed 7 items from the NCI PROCTCAE at each visit. All SAEs and AEs collected per protocol and meeting reporting requirements are reported. 101 patients were randomized, but 1 withdrew immediately following randomization with no study procedures completed/data collected so this patient is not included in AE/SAE reporting.
|
Other adverse events
| Measure |
Biomarker Guided Arm
n=50 participants at risk
NTproBNP will be monitored serially prior to start of anthracycline based chemotherapy, at each cycle of anthracycline based chemotherapy, and at 3 month intervals for a total of 12 months. NTproBNP above the upper limit of normal triggers initiation and titration of neurohormonal therapy per protocol algorithm.
Clinical, echocardiographic, and biomarker data will be collected on all patients at baseline and at standardized intervals at 3, 6, 9, and 12 months following initiation of Anthracycline chemotherapy.
|
Usual Care
n=50 participants at risk
NTproBNP will not be monitored while patients are on study unless clinically indicated. Clinical, echocardiographic, and biomarker data will be collected on all patients at baseline and at standardized intervals at 3, 6, 9, and 12 months following initiation of Anthracycline chemotherapy. Biomarker data will also be collected at each cycle of Anthracycline chemotherapy.
|
|---|---|---|
|
Renal and urinary disorders
Acute Kidney Injury
|
4.0%
2/50 • From enrollment through end of follow-up (up to 12 months)
At each visit, grade 3 (CTCAEv5) and higher targeted events as well as events ending in death were collected by chart review and patient interview. Patients also completed 7 items from the NCI PROCTCAE at each visit. All SAEs and AEs collected per protocol and meeting reporting requirements are reported. 101 patients were randomized, but 1 withdrew immediately following randomization with no study procedures completed/data collected so this patient is not included in AE/SAE reporting.
|
4.0%
2/50 • From enrollment through end of follow-up (up to 12 months)
At each visit, grade 3 (CTCAEv5) and higher targeted events as well as events ending in death were collected by chart review and patient interview. Patients also completed 7 items from the NCI PROCTCAE at each visit. All SAEs and AEs collected per protocol and meeting reporting requirements are reported. 101 patients were randomized, but 1 withdrew immediately following randomization with no study procedures completed/data collected so this patient is not included in AE/SAE reporting.
|
|
Cardiac disorders
Chest pain - cardiac
|
2.0%
1/50 • From enrollment through end of follow-up (up to 12 months)
At each visit, grade 3 (CTCAEv5) and higher targeted events as well as events ending in death were collected by chart review and patient interview. Patients also completed 7 items from the NCI PROCTCAE at each visit. All SAEs and AEs collected per protocol and meeting reporting requirements are reported. 101 patients were randomized, but 1 withdrew immediately following randomization with no study procedures completed/data collected so this patient is not included in AE/SAE reporting.
|
0.00%
0/50 • From enrollment through end of follow-up (up to 12 months)
At each visit, grade 3 (CTCAEv5) and higher targeted events as well as events ending in death were collected by chart review and patient interview. Patients also completed 7 items from the NCI PROCTCAE at each visit. All SAEs and AEs collected per protocol and meeting reporting requirements are reported. 101 patients were randomized, but 1 withdrew immediately following randomization with no study procedures completed/data collected so this patient is not included in AE/SAE reporting.
|
|
Metabolism and nutrition disorders
Dehydration
|
4.0%
2/50 • From enrollment through end of follow-up (up to 12 months)
At each visit, grade 3 (CTCAEv5) and higher targeted events as well as events ending in death were collected by chart review and patient interview. Patients also completed 7 items from the NCI PROCTCAE at each visit. All SAEs and AEs collected per protocol and meeting reporting requirements are reported. 101 patients were randomized, but 1 withdrew immediately following randomization with no study procedures completed/data collected so this patient is not included in AE/SAE reporting.
|
2.0%
1/50 • From enrollment through end of follow-up (up to 12 months)
At each visit, grade 3 (CTCAEv5) and higher targeted events as well as events ending in death were collected by chart review and patient interview. Patients also completed 7 items from the NCI PROCTCAE at each visit. All SAEs and AEs collected per protocol and meeting reporting requirements are reported. 101 patients were randomized, but 1 withdrew immediately following randomization with no study procedures completed/data collected so this patient is not included in AE/SAE reporting.
|
|
Nervous system disorders
Dizziness
|
40.0%
20/50 • From enrollment through end of follow-up (up to 12 months)
At each visit, grade 3 (CTCAEv5) and higher targeted events as well as events ending in death were collected by chart review and patient interview. Patients also completed 7 items from the NCI PROCTCAE at each visit. All SAEs and AEs collected per protocol and meeting reporting requirements are reported. 101 patients were randomized, but 1 withdrew immediately following randomization with no study procedures completed/data collected so this patient is not included in AE/SAE reporting.
|
32.0%
16/50 • From enrollment through end of follow-up (up to 12 months)
At each visit, grade 3 (CTCAEv5) and higher targeted events as well as events ending in death were collected by chart review and patient interview. Patients also completed 7 items from the NCI PROCTCAE at each visit. All SAEs and AEs collected per protocol and meeting reporting requirements are reported. 101 patients were randomized, but 1 withdrew immediately following randomization with no study procedures completed/data collected so this patient is not included in AE/SAE reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Dypsnea
|
6.0%
3/50 • From enrollment through end of follow-up (up to 12 months)
At each visit, grade 3 (CTCAEv5) and higher targeted events as well as events ending in death were collected by chart review and patient interview. Patients also completed 7 items from the NCI PROCTCAE at each visit. All SAEs and AEs collected per protocol and meeting reporting requirements are reported. 101 patients were randomized, but 1 withdrew immediately following randomization with no study procedures completed/data collected so this patient is not included in AE/SAE reporting.
|
2.0%
1/50 • From enrollment through end of follow-up (up to 12 months)
At each visit, grade 3 (CTCAEv5) and higher targeted events as well as events ending in death were collected by chart review and patient interview. Patients also completed 7 items from the NCI PROCTCAE at each visit. All SAEs and AEs collected per protocol and meeting reporting requirements are reported. 101 patients were randomized, but 1 withdrew immediately following randomization with no study procedures completed/data collected so this patient is not included in AE/SAE reporting.
|
|
General disorders
Fatigue
|
54.0%
27/50 • From enrollment through end of follow-up (up to 12 months)
At each visit, grade 3 (CTCAEv5) and higher targeted events as well as events ending in death were collected by chart review and patient interview. Patients also completed 7 items from the NCI PROCTCAE at each visit. All SAEs and AEs collected per protocol and meeting reporting requirements are reported. 101 patients were randomized, but 1 withdrew immediately following randomization with no study procedures completed/data collected so this patient is not included in AE/SAE reporting.
|
34.0%
17/50 • From enrollment through end of follow-up (up to 12 months)
At each visit, grade 3 (CTCAEv5) and higher targeted events as well as events ending in death were collected by chart review and patient interview. Patients also completed 7 items from the NCI PROCTCAE at each visit. All SAEs and AEs collected per protocol and meeting reporting requirements are reported. 101 patients were randomized, but 1 withdrew immediately following randomization with no study procedures completed/data collected so this patient is not included in AE/SAE reporting.
|
|
Nervous system disorders
Headache
|
4.0%
2/50 • From enrollment through end of follow-up (up to 12 months)
At each visit, grade 3 (CTCAEv5) and higher targeted events as well as events ending in death were collected by chart review and patient interview. Patients also completed 7 items from the NCI PROCTCAE at each visit. All SAEs and AEs collected per protocol and meeting reporting requirements are reported. 101 patients were randomized, but 1 withdrew immediately following randomization with no study procedures completed/data collected so this patient is not included in AE/SAE reporting.
|
0.00%
0/50 • From enrollment through end of follow-up (up to 12 months)
At each visit, grade 3 (CTCAEv5) and higher targeted events as well as events ending in death were collected by chart review and patient interview. Patients also completed 7 items from the NCI PROCTCAE at each visit. All SAEs and AEs collected per protocol and meeting reporting requirements are reported. 101 patients were randomized, but 1 withdrew immediately following randomization with no study procedures completed/data collected so this patient is not included in AE/SAE reporting.
|
|
Cardiac disorders
Heart failure
|
2.0%
1/50 • From enrollment through end of follow-up (up to 12 months)
At each visit, grade 3 (CTCAEv5) and higher targeted events as well as events ending in death were collected by chart review and patient interview. Patients also completed 7 items from the NCI PROCTCAE at each visit. All SAEs and AEs collected per protocol and meeting reporting requirements are reported. 101 patients were randomized, but 1 withdrew immediately following randomization with no study procedures completed/data collected so this patient is not included in AE/SAE reporting.
|
0.00%
0/50 • From enrollment through end of follow-up (up to 12 months)
At each visit, grade 3 (CTCAEv5) and higher targeted events as well as events ending in death were collected by chart review and patient interview. Patients also completed 7 items from the NCI PROCTCAE at each visit. All SAEs and AEs collected per protocol and meeting reporting requirements are reported. 101 patients were randomized, but 1 withdrew immediately following randomization with no study procedures completed/data collected so this patient is not included in AE/SAE reporting.
|
|
Vascular disorders
Hypertension
|
22.0%
11/50 • From enrollment through end of follow-up (up to 12 months)
At each visit, grade 3 (CTCAEv5) and higher targeted events as well as events ending in death were collected by chart review and patient interview. Patients also completed 7 items from the NCI PROCTCAE at each visit. All SAEs and AEs collected per protocol and meeting reporting requirements are reported. 101 patients were randomized, but 1 withdrew immediately following randomization with no study procedures completed/data collected so this patient is not included in AE/SAE reporting.
|
14.0%
7/50 • From enrollment through end of follow-up (up to 12 months)
At each visit, grade 3 (CTCAEv5) and higher targeted events as well as events ending in death were collected by chart review and patient interview. Patients also completed 7 items from the NCI PROCTCAE at each visit. All SAEs and AEs collected per protocol and meeting reporting requirements are reported. 101 patients were randomized, but 1 withdrew immediately following randomization with no study procedures completed/data collected so this patient is not included in AE/SAE reporting.
|
|
Vascular disorders
Hypotension
|
6.0%
3/50 • From enrollment through end of follow-up (up to 12 months)
At each visit, grade 3 (CTCAEv5) and higher targeted events as well as events ending in death were collected by chart review and patient interview. Patients also completed 7 items from the NCI PROCTCAE at each visit. All SAEs and AEs collected per protocol and meeting reporting requirements are reported. 101 patients were randomized, but 1 withdrew immediately following randomization with no study procedures completed/data collected so this patient is not included in AE/SAE reporting.
|
0.00%
0/50 • From enrollment through end of follow-up (up to 12 months)
At each visit, grade 3 (CTCAEv5) and higher targeted events as well as events ending in death were collected by chart review and patient interview. Patients also completed 7 items from the NCI PROCTCAE at each visit. All SAEs and AEs collected per protocol and meeting reporting requirements are reported. 101 patients were randomized, but 1 withdrew immediately following randomization with no study procedures completed/data collected so this patient is not included in AE/SAE reporting.
|
|
Cardiac disorders
Left Ventricular Systolic Dysfunction
|
2.0%
1/50 • From enrollment through end of follow-up (up to 12 months)
At each visit, grade 3 (CTCAEv5) and higher targeted events as well as events ending in death were collected by chart review and patient interview. Patients also completed 7 items from the NCI PROCTCAE at each visit. All SAEs and AEs collected per protocol and meeting reporting requirements are reported. 101 patients were randomized, but 1 withdrew immediately following randomization with no study procedures completed/data collected so this patient is not included in AE/SAE reporting.
|
0.00%
0/50 • From enrollment through end of follow-up (up to 12 months)
At each visit, grade 3 (CTCAEv5) and higher targeted events as well as events ending in death were collected by chart review and patient interview. Patients also completed 7 items from the NCI PROCTCAE at each visit. All SAEs and AEs collected per protocol and meeting reporting requirements are reported. 101 patients were randomized, but 1 withdrew immediately following randomization with no study procedures completed/data collected so this patient is not included in AE/SAE reporting.
|
|
Nervous system disorders
Syncope
|
6.0%
3/50 • From enrollment through end of follow-up (up to 12 months)
At each visit, grade 3 (CTCAEv5) and higher targeted events as well as events ending in death were collected by chart review and patient interview. Patients also completed 7 items from the NCI PROCTCAE at each visit. All SAEs and AEs collected per protocol and meeting reporting requirements are reported. 101 patients were randomized, but 1 withdrew immediately following randomization with no study procedures completed/data collected so this patient is not included in AE/SAE reporting.
|
6.0%
3/50 • From enrollment through end of follow-up (up to 12 months)
At each visit, grade 3 (CTCAEv5) and higher targeted events as well as events ending in death were collected by chart review and patient interview. Patients also completed 7 items from the NCI PROCTCAE at each visit. All SAEs and AEs collected per protocol and meeting reporting requirements are reported. 101 patients were randomized, but 1 withdrew immediately following randomization with no study procedures completed/data collected so this patient is not included in AE/SAE reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
48.0%
24/50 • From enrollment through end of follow-up (up to 12 months)
At each visit, grade 3 (CTCAEv5) and higher targeted events as well as events ending in death were collected by chart review and patient interview. Patients also completed 7 items from the NCI PROCTCAE at each visit. All SAEs and AEs collected per protocol and meeting reporting requirements are reported. 101 patients were randomized, but 1 withdrew immediately following randomization with no study procedures completed/data collected so this patient is not included in AE/SAE reporting.
|
40.0%
20/50 • From enrollment through end of follow-up (up to 12 months)
At each visit, grade 3 (CTCAEv5) and higher targeted events as well as events ending in death were collected by chart review and patient interview. Patients also completed 7 items from the NCI PROCTCAE at each visit. All SAEs and AEs collected per protocol and meeting reporting requirements are reported. 101 patients were randomized, but 1 withdrew immediately following randomization with no study procedures completed/data collected so this patient is not included in AE/SAE reporting.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
40.0%
20/50 • From enrollment through end of follow-up (up to 12 months)
At each visit, grade 3 (CTCAEv5) and higher targeted events as well as events ending in death were collected by chart review and patient interview. Patients also completed 7 items from the NCI PROCTCAE at each visit. All SAEs and AEs collected per protocol and meeting reporting requirements are reported. 101 patients were randomized, but 1 withdrew immediately following randomization with no study procedures completed/data collected so this patient is not included in AE/SAE reporting.
|
34.0%
17/50 • From enrollment through end of follow-up (up to 12 months)
At each visit, grade 3 (CTCAEv5) and higher targeted events as well as events ending in death were collected by chart review and patient interview. Patients also completed 7 items from the NCI PROCTCAE at each visit. All SAEs and AEs collected per protocol and meeting reporting requirements are reported. 101 patients were randomized, but 1 withdrew immediately following randomization with no study procedures completed/data collected so this patient is not included in AE/SAE reporting.
|
|
Cardiac disorders
Chest Pain
|
26.0%
13/50 • From enrollment through end of follow-up (up to 12 months)
At each visit, grade 3 (CTCAEv5) and higher targeted events as well as events ending in death were collected by chart review and patient interview. Patients also completed 7 items from the NCI PROCTCAE at each visit. All SAEs and AEs collected per protocol and meeting reporting requirements are reported. 101 patients were randomized, but 1 withdrew immediately following randomization with no study procedures completed/data collected so this patient is not included in AE/SAE reporting.
|
18.0%
9/50 • From enrollment through end of follow-up (up to 12 months)
At each visit, grade 3 (CTCAEv5) and higher targeted events as well as events ending in death were collected by chart review and patient interview. Patients also completed 7 items from the NCI PROCTCAE at each visit. All SAEs and AEs collected per protocol and meeting reporting requirements are reported. 101 patients were randomized, but 1 withdrew immediately following randomization with no study procedures completed/data collected so this patient is not included in AE/SAE reporting.
|
|
Cardiac disorders
Palpitations
|
28.0%
14/50 • From enrollment through end of follow-up (up to 12 months)
At each visit, grade 3 (CTCAEv5) and higher targeted events as well as events ending in death were collected by chart review and patient interview. Patients also completed 7 items from the NCI PROCTCAE at each visit. All SAEs and AEs collected per protocol and meeting reporting requirements are reported. 101 patients were randomized, but 1 withdrew immediately following randomization with no study procedures completed/data collected so this patient is not included in AE/SAE reporting.
|
38.0%
19/50 • From enrollment through end of follow-up (up to 12 months)
At each visit, grade 3 (CTCAEv5) and higher targeted events as well as events ending in death were collected by chart review and patient interview. Patients also completed 7 items from the NCI PROCTCAE at each visit. All SAEs and AEs collected per protocol and meeting reporting requirements are reported. 101 patients were randomized, but 1 withdrew immediately following randomization with no study procedures completed/data collected so this patient is not included in AE/SAE reporting.
|
|
Vascular disorders
Limb Edema
|
38.0%
19/50 • From enrollment through end of follow-up (up to 12 months)
At each visit, grade 3 (CTCAEv5) and higher targeted events as well as events ending in death were collected by chart review and patient interview. Patients also completed 7 items from the NCI PROCTCAE at each visit. All SAEs and AEs collected per protocol and meeting reporting requirements are reported. 101 patients were randomized, but 1 withdrew immediately following randomization with no study procedures completed/data collected so this patient is not included in AE/SAE reporting.
|
46.0%
23/50 • From enrollment through end of follow-up (up to 12 months)
At each visit, grade 3 (CTCAEv5) and higher targeted events as well as events ending in death were collected by chart review and patient interview. Patients also completed 7 items from the NCI PROCTCAE at each visit. All SAEs and AEs collected per protocol and meeting reporting requirements are reported. 101 patients were randomized, but 1 withdrew immediately following randomization with no study procedures completed/data collected so this patient is not included in AE/SAE reporting.
|
Additional Information
Bonnie Ky
Perelman School of Medicine at the University of Pennsylvania
Phone: 215-662-7700
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place