Trial Outcomes & Findings for Chronotropic Incompetence (CI) Diagnostic Algorithm in Heart Failure Patients (NCT NCT02358603)
NCT ID: NCT02358603
Last Updated: 2020-02-05
Results Overview
Compare chronotropic incompetence index in patients with heart failure using an interventional diagnostic algorithm compared to standard of care diagnostics. Chronotropic Index = \[achieved maximal HR-resting HR\]/\[age-predicted maximal HR-resting HR\]. Normal CI is \~ 1 with low CI considered \< 0.8 Measurement described as: Chronotropic index=HRR/metabolic reserve.
TERMINATED
NA
48 participants
Implant through 6 months
2020-02-05
Participant Flow
Participant milestones
| Measure |
Case Group
At the beginning of the study, each subject of the case group will complete echo examination and related lab test for BNP. During the study, each subject will have a six minutes' walk test and 24 hour ambulatory monitoring while having an ActiGraph device placed on his/her wrist and a Holter device with ECG electrodes placed on his/her chest. The treadmill test is optional to patients per physicians' instruction and/or patients' own judgment. It would be performed at the end of the study if chosen.
|
Control Group
Each subject of the control group will do the same test and examination with the subjects in the case group.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
8
|
|
Overall Study
COMPLETED
|
40
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Chronotropic Incompetence (CI) Diagnostic Algorithm in Heart Failure Patients
Baseline characteristics by cohort
| Measure |
Case Group
n=40 Participants
At the beginning of the study, each subject of the case group will complete echo examination and related lab test for BNP. During the study, each subject will have a six minutes' walk test and 24 hour ambulatory monitoring while having an ActiGraph device placed on his/her wrist and a Holter device with ECG electrodes placed on his/her chest. The treadmill test is optional to patients per physicians' instruction and/or patients' own judgment. It would be performed at the end of the study if chosen.
|
Control Group
n=8 Participants
Each subject of the control group will do the same test and examination with the subjects in the case group.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.4 years
STANDARD_DEVIATION 11.7 • n=99 Participants
|
59.5 years
STANDARD_DEVIATION 3.2 • n=107 Participants
|
55.3 years
STANDARD_DEVIATION 10.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Implant through 6 monthsPopulation: Compare the case group for chronotropic incompetence using the interventional algorithm versus those in the control group.
Compare chronotropic incompetence index in patients with heart failure using an interventional diagnostic algorithm compared to standard of care diagnostics. Chronotropic Index = \[achieved maximal HR-resting HR\]/\[age-predicted maximal HR-resting HR\]. Normal CI is \~ 1 with low CI considered \< 0.8 Measurement described as: Chronotropic index=HRR/metabolic reserve.
Outcome measures
| Measure |
Case Group
n=40 Participants
At the beginning of the study, each subject of the case group will complete echo examination and related lab test for BNP. During the study, each subject will have a six minutes' walk test and 24 hour ambulatory monitoring while having an ActiGraph device placed on his/her wrist and a Holter device with ECG electrodes placed on his/her chest. The treadmill test is optional to patients per physicians' instruction and/or patients' own judgment. It would be performed at the end of the study if chosen.
|
Control Group
n=8 Participants
Each subject of the control group will do the same test and examination with the subjects in the case group.
|
|---|---|---|
|
Chronotropic Incompetence Index of Patients With Heart Failure Disease
|
0.61 Index
Standard Deviation 0.11
|
0.72 Index
Standard Deviation 0.01
|
Adverse Events
Case Group
Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Zhao, Jianrong
Department of Cardiology, Ruijin Hospital Luwan Branch, Shanghai Jiao Tong University School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place