Trial Outcomes & Findings for Right Ventricular Function and Exercise Capacity in Patients With Continuous-flow Left Ventricular Assist Devices (NCT NCT02658136)
NCT ID: NCT02658136
Last Updated: 2022-06-14
Results Overview
Cardiopulmonary exercise testing (CPET) measuring peak oxygen uptake in ml/kg/min.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
Day 1
Results posted on
2022-06-14
Participant Flow
Participant milestones
| Measure |
1 Arm Study: CCT Estimated Right Ventricular Function.
Fifteen patients with HeartMate (HM) II or III underwent echocardiography and maximal cardiopulmonary exercise test. Subsequently, contrast-enhanced 4D Cardiac Computed Tomography(CCT) scans were performed at rest and immediately after two minutes of supine 25 Watt ergometer bike exercise.
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|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Right Ventricular Function and Exercise Capacity in Patients With Continuous-flow Left Ventricular Assist Devices
Baseline characteristics by cohort
| Measure |
1 Arm Study: CCT Estimated Right Ventricular Function.
n=15 Participants
Cardiac Computed tomography
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|---|---|
|
Age, Customized
Age
|
60 years
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1Cardiopulmonary exercise testing (CPET) measuring peak oxygen uptake in ml/kg/min.
Outcome measures
| Measure |
Single-arm Study: Exercise and Right Ventricular Function in Patients With LVADs
n=15 Participants
Peak oxygen uptake (ml/kg/min) was measured on upright ergometer bicycle
|
|---|---|
|
Peak Oxygen Uptake
|
15 ml/kg/min
Standard Deviation 5
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SECONDARY outcome
Timeframe: Day 1Right ventricular function during exercise was estimated by use of contrast enhanced cardiac computed tomography.
Outcome measures
| Measure |
Single-arm Study: Exercise and Right Ventricular Function in Patients With LVADs
n=15 Participants
Peak oxygen uptake (ml/kg/min) was measured on upright ergometer bicycle
|
|---|---|
|
Right Ventricular Function (RVEF) During Exercise
|
37 percent of ejected blood
Standard Deviation 8
|
Adverse Events
1 Arm Study: CCT Estimated Right Ventricular Function.
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