Trial Outcomes & Findings for Novel Mechanisms and Predictors of VEGF Receptor Inhibitor- or Immune Checkpoint Inhibitor-Associated Hypertension and Cardiovascular Disease (NCT NCT03709771)
NCT ID: NCT03709771
Last Updated: 2024-01-12
Results Overview
Mean 24 hour blood pressure from ambulatory 24 hour recording
Recruitment status
TERMINATED
Target enrollment
2 participants
Primary outcome timeframe
Baseline and 1 month
Results posted on
2024-01-12
Participant Flow
Participant milestones
| Measure |
VEGF Inhibitor Alone
Ambulatory Blood Pressure Measurement: Baseline: Subjects will undergo an abbreviated physical exam, review changes in medical history since last oncology visit, blood collection, urine collection, blood pressure and heart rate in triplicate, baseline and hyperemic digital velocity time interval (VTI) using pulse amplitude tonometry, cubital vein endothelial cell harvest, and ambulatory 24 blood pressure measurement.
Follow-up Visit (approx 1 month after starting treatment): Review changes in medications and any medical events that happened since the last visit, an abbreviated physical exam, blood collection, urine collection, blood pressure and heart rate in triplicate, baseline and hyperemic velocity time interval (VTI), digital pulse amplitude tonometry, endothelial cell harvest, and ambulatory 24 blood pressure.
|
Immune Checkpoint Inhibitor (ICI) Alone
Ambulatory Blood Pressure Measurement: Baseline: Subjects will undergo an abbreviated physical exam, review changes in medical history since last oncology visit, blood collection, urine collection, blood pressure and heart rate in triplicate, baseline and hyperemic digital velocity time interval (VTI) using pulse amplitude tonometry, cubital vein endothelial cell harvest, and ambulatory 24 blood pressure measurement.
Follow-up Visit (approx 1 month after starting treatment): Review changes in medications and any medical events that happened since the last visit, an abbreviated physical exam, blood collection, urine collection, blood pressure and heart rate in triplicate, baseline and hyperemic velocity time interval (VTI), digital pulse amplitude tonometry, endothelial cell harvest, and ambulatory 24 blood pressure.
|
Combination (VEGF Inhibitor + ICI, or Combination of ICI)
Ambulatory Blood Pressure Measurement: Baseline: Subjects will undergo an abbreviated physical exam, review changes in medical history since last oncology visit, blood collection, urine collection, blood pressure and heart rate in triplicate, baseline and hyperemic digital velocity time interval (VTI) using pulse amplitude tonometry, cubital vein endothelial cell harvest, and ambulatory 24 blood pressure measurement.
Follow-up Visit (approx 1 month after starting treatment): Review changes in medications and any medical events that happened since the last visit, an abbreviated physical exam, blood collection, urine collection, blood pressure and heart rate in triplicate, baseline and hyperemic velocity time interval (VTI), digital pulse amplitude tonometry, endothelial cell harvest, and ambulatory 24 blood pressure.
|
No Treatment
Ambulatory Blood Pressure Measurement: Baseline: Subjects will undergo an abbreviated physical exam, review changes in medical history since last oncology visit, blood collection, urine collection, blood pressure and heart rate in triplicate, baseline and hyperemic digital velocity time interval (VTI) using pulse amplitude tonometry, cubital vein endothelial cell harvest, and ambulatory 24 blood pressure measurement.
Follow-up Visit (approx 1 month after starting treatment): Review changes in medications and any medical events that happened since the last visit, an abbreviated physical exam, blood collection, urine collection, blood pressure and heart rate in triplicate, baseline and hyperemic velocity time interval (VTI), digital pulse amplitude tonometry, endothelial cell harvest, and ambulatory 24 blood pressure.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
0
|
1
|
1
|
0
|
|
Overall Study
COMPLETED
|
0
|
1
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Novel Mechanisms and Predictors of VEGF Receptor Inhibitor- or Immune Checkpoint Inhibitor-Associated Hypertension and Cardiovascular Disease
Baseline characteristics by cohort
| Measure |
VEGF Inhibitor Alone
Ambulatory Blood Pressure Measurement: Baseline: Subjects will undergo an abbreviated physical exam, review changes in medical history since last oncology visit, blood collection, urine collection, blood pressure and heart rate in triplicate, baseline and hyperemic digital velocity time interval (VTI) using pulse amplitude tonometry, cubital vein endothelial cell harvest, and ambulatory 24 blood pressure measurement.
Follow-up Visit (approx 1 month after starting treatment): Review changes in medications and any medical events that happened since the last visit, an abbreviated physical exam, blood collection, urine collection, blood pressure and heart rate in triplicate, baseline and hyperemic velocity time interval (VTI), digital pulse amplitude tonometry, endothelial cell harvest, and ambulatory 24 blood pressure.
|
Immune Checkpoint Inhibitor (ICI) Alone
n=1 Participants
Ambulatory Blood Pressure Measurement: Baseline: Subjects will undergo an abbreviated physical exam, review changes in medical history since last oncology visit, blood collection, urine collection, blood pressure and heart rate in triplicate, baseline and hyperemic digital velocity time interval (VTI) using pulse amplitude tonometry, cubital vein endothelial cell harvest, and ambulatory 24 blood pressure measurement.
Follow-up Visit (approx 1 month after starting treatment): Review changes in medications and any medical events that happened since the last visit, an abbreviated physical exam, blood collection, urine collection, blood pressure and heart rate in triplicate, baseline and hyperemic velocity time interval (VTI), digital pulse amplitude tonometry, endothelial cell harvest, and ambulatory 24 blood pressure.
|
Combination (VEGF Inhibitor + ICI, or Combination of ICI)
n=1 Participants
Ambulatory Blood Pressure Measurement: Baseline: Subjects will undergo an abbreviated physical exam, review changes in medical history since last oncology visit, blood collection, urine collection, blood pressure and heart rate in triplicate, baseline and hyperemic digital velocity time interval (VTI) using pulse amplitude tonometry, cubital vein endothelial cell harvest, and ambulatory 24 blood pressure measurement.
Follow-up Visit (approx 1 month after starting treatment): Review changes in medications and any medical events that happened since the last visit, an abbreviated physical exam, blood collection, urine collection, blood pressure and heart rate in triplicate, baseline and hyperemic velocity time interval (VTI), digital pulse amplitude tonometry, endothelial cell harvest, and ambulatory 24 blood pressure.
|
No Treatment
Ambulatory Blood Pressure Measurement: Baseline: Subjects will undergo an abbreviated physical exam, review changes in medical history since last oncology visit, blood collection, urine collection, blood pressure and heart rate in triplicate, baseline and hyperemic digital velocity time interval (VTI) using pulse amplitude tonometry, cubital vein endothelial cell harvest, and ambulatory 24 blood pressure measurement.
Follow-up Visit (approx 1 month after starting treatment): Review changes in medications and any medical events that happened since the last visit, an abbreviated physical exam, blood collection, urine collection, blood pressure and heart rate in triplicate, baseline and hyperemic velocity time interval (VTI), digital pulse amplitude tonometry, endothelial cell harvest, and ambulatory 24 blood pressure.
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
—
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
—
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
—
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
—
|
1 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
—
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
—
|
1 Participants
n=31 Participants
|
|
Sex: Female, Male
Female
|
—
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
—
|
1 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
—
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
—
|
1 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
—
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
—
|
0 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
—
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
—
|
2 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
—
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
—
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
—
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
—
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
—
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
—
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
—
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
—
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
—
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
—
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
—
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
—
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
—
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
—
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
—
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
—
|
0 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Baseline and 1 monthPopulation: Data analysis was not completed because only one participant completed the study and disclosing data could violate privacy interests.
Mean 24 hour blood pressure from ambulatory 24 hour recording
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 1 monthPopulation: Data analysis was not completed because only one participant completed the study and disclosing data could violate privacy interests.
Digital pulse amplitude will be measured using peripheral artery tonometry
Outcome measures
Outcome data not reported
Adverse Events
VEGF Inhibitor Alone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Immune Checkpoint Inhibitor (ICI) Alone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Combination (VEGF Inhibitor + ICI, or Combination of ICI)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place