Trial Outcomes & Findings for Exercise Training in Heart Failure: Changes in Cardiac Structure and Function (NCT NCT02275819)
NCT ID: NCT02275819
Last Updated: 2021-03-08
Results Overview
Change in left ventricular ejection fraction.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
11 participants
Primary outcome timeframe
Baseline and endpoint at 3-5 months
Results posted on
2021-03-08
Participant Flow
Recruitment occurred at VA Boston Healthcare System cardiology related clinics from 6/6/2016 to 12/21/2018. As per the protocol the recruitment was supposed to begin in 2014. Unfortunately there were a number of issues including the fact that the parent study moved to Pittsburgh and we were not able to start recruitment till 2016.
13 participants were consented but only 11 were enrolled. Two were excluded from randomization due to subsequent echocardiogram or pulmonary function screening not meeting enrollment criteria. One was withdrawn after enrollment due to increasing symptoms of heart failure. Due to the small number of participants enrolled in each of the active intervention arms we combined participants from both intervention groups and analyzed against the controls.
Participant milestones
| Measure |
Control
Will not receive intervention with exercise
|
Intervention Group
2 groups will receive 2 different types of exercise
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
6
|
|
Overall Study
COMPLETED
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Control
Will not receive intervention with exercise
|
Intervention Group
2 groups will receive 2 different types of exercise
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
Exercise Training in Heart Failure: Changes in Cardiac Structure and Function
Baseline characteristics by cohort
| Measure |
Control
n=5 Participants
Will not receive intervention with exercise
|
Intervention Group
n=5 Participants
2 groups will receive 2 different types of exercise
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Age, Continuous
|
69.6 years
STANDARD_DEVIATION 8.4 • n=99 Participants
|
67.2 years
STANDARD_DEVIATION 4.4 • n=107 Participants
|
68.4 years
STANDARD_DEVIATION 6.4 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and endpoint at 3-5 monthsChange in left ventricular ejection fraction.
Outcome measures
| Measure |
Control
n=5 Participants
Will not receive intervention with exercise
|
Intervention Group
n=5 Participants
2 groups will receive 2 different types of exercise
|
|---|---|---|
|
Change in Left Ventricular Systolic Function.
|
.82 percent LVEF
Standard Deviation 3.54
|
-1.90 percent LVEF
Standard Deviation 1.14
|
PRIMARY outcome
Timeframe: Baseline and endpoint at 3-5 monthsChange in left ventricular mass.
Outcome measures
| Measure |
Control
n=5 Participants
Will not receive intervention with exercise
|
Intervention Group
n=5 Participants
2 groups will receive 2 different types of exercise
|
|---|---|---|
|
Change in Left Ventricular Structure.
|
-34.8 grams
Standard Deviation 49.8
|
3.1 grams
Standard Deviation 40.8
|
PRIMARY outcome
Timeframe: Baseline and endpoint at 3-5 monthsChange in mitral annular early diastolic velocity (e')
Outcome measures
| Measure |
Control
n=5 Participants
Will not receive intervention with exercise
|
Intervention Group
n=5 Participants
2 groups will receive 2 different types of exercise
|
|---|---|---|
|
Change in Diastolic Function.
|
.31 centimeters/second
Standard Deviation .68
|
-1.07 centimeters/second
Standard Deviation 1.42
|
PRIMARY outcome
Timeframe: Baseline and endpoint at 3-5 monthsChange in the ratio of early mitral in-flow velocity (E) to mitral annular early diastolic velocity (e')
Outcome measures
| Measure |
Control
n=5 Participants
Will not receive intervention with exercise
|
Intervention Group
n=5 Participants
2 groups will receive 2 different types of exercise
|
|---|---|---|
|
Change in Left Ventricular (LV) Diastolic Function
|
-1.85 ratio
Standard Deviation 3.06
|
2.68 ratio
Standard Deviation 3.49
|
PRIMARY outcome
Timeframe: Baseline and endpoint at 3-5 monthsChange in tricuspid annular tissue doppler velocity
Outcome measures
| Measure |
Control
n=5 Participants
Will not receive intervention with exercise
|
Intervention Group
n=5 Participants
2 groups will receive 2 different types of exercise
|
|---|---|---|
|
Change in Right Ventricular Function
|
0.16 centimeters/second
Standard Deviation 1.04
|
-0.70 centimeters/second
Standard Deviation 2.05
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intervention Group
Serious events: 4 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Control
n=5 participants at risk
Will not receive intervention with exercise
|
Intervention Group
n=5 participants at risk
2 groups will receive 2 different types of exercise
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
ER Visit
|
0.00%
0/5 • Adverse event data was collected while participants were enrolled from enrollment until collection of the final study endpoint at 3-5 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected while participants were enrolled from enrollment until collection of the final study endpoint at 3-5 months.
|
|
Cardiac disorders
HF exacerbation
|
0.00%
0/5 • Adverse event data was collected while participants were enrolled from enrollment until collection of the final study endpoint at 3-5 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected while participants were enrolled from enrollment until collection of the final study endpoint at 3-5 months.
|
|
Cardiac disorders
Low BP
|
0.00%
0/5 • Adverse event data was collected while participants were enrolled from enrollment until collection of the final study endpoint at 3-5 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected while participants were enrolled from enrollment until collection of the final study endpoint at 3-5 months.
|
|
Cardiac disorders
A-fib Hospitalization
|
0.00%
0/5 • Adverse event data was collected while participants were enrolled from enrollment until collection of the final study endpoint at 3-5 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected while participants were enrolled from enrollment until collection of the final study endpoint at 3-5 months.
|
Other adverse events
| Measure |
Control
n=5 participants at risk
Will not receive intervention with exercise
|
Intervention Group
n=5 participants at risk
2 groups will receive 2 different types of exercise
|
|---|---|---|
|
General disorders
Not Fasted
|
0.00%
0/5 • Adverse event data was collected while participants were enrolled from enrollment until collection of the final study endpoint at 3-5 months.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected while participants were enrolled from enrollment until collection of the final study endpoint at 3-5 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place