Trial Outcomes & Findings for Effect of Carvedilol on Exercise Performance in Fontan Patients (NCT NCT02946892)
NCT ID: NCT02946892
Last Updated: 2021-01-22
Results Overview
during exercise test on week 12 and week 30
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
26 participants
Primary outcome timeframe
on week 12 and week 30 of the study
Results posted on
2021-01-22
Participant Flow
Participant milestones
| Measure |
Carvedilol First, Then Placebo
Study participants will receive carvedilol for 12 weeks, washout for 6 weeks, then placebo for 12 weeks
|
Placebo First, Then Carvedilol
Study participants will receive placebo (sugar pill) for 12 weeks, then washout for 6 weeks, then carvedilol for 12 weeks
|
|---|---|---|
|
First Intervention (12 Weeks)
STARTED
|
11
|
15
|
|
First Intervention (12 Weeks)
COMPLETED
|
11
|
14
|
|
First Intervention (12 Weeks)
NOT COMPLETED
|
0
|
1
|
|
Washout (6 Weeks)
STARTED
|
11
|
14
|
|
Washout (6 Weeks)
COMPLETED
|
9
|
14
|
|
Washout (6 Weeks)
NOT COMPLETED
|
2
|
0
|
|
Second Intervention
STARTED
|
9
|
14
|
|
Second Intervention
COMPLETED
|
9
|
14
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Carvedilol on Exercise Performance in Fontan Patients
Baseline characteristics by cohort
| Measure |
All Study Participants
n=23 Participants
Since All Participants Would Be Randomized to Both Interventions, all Patients were Analyzed
|
|---|---|
|
Age, Continuous
|
14.9 years
STANDARD_DEVIATION 2.8 • n=99 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Non-Caucasian
|
5 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
18 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: on week 12 and week 30 of the studyduring exercise test on week 12 and week 30
Outcome measures
| Measure |
Carvedilol
n=23 Participants
Study participants will receive carvedilol for 12 weeks
Carvedilol: Carvedilol will be given for 12 weeks and then an exercise test will be performed
|
Placebo
n=23 Participants
Study participants will receive placebo (sugar pill) for 12 weeks
Placebo: Placebo will be given for 12 weeks and then an exercise test will be performed
|
|---|---|---|
|
Change in Peak Oxygen Uptake From Baseline Peak Oxygen Uptake
|
-2.01 ml/kg/min
Standard Deviation 3.57
|
-1.01 ml/kg/min
Standard Deviation 3.36
|
SECONDARY outcome
Timeframe: on week 12 and week 30 of the studyduring exercise test on week 12 and week 30
Outcome measures
| Measure |
Carvedilol
n=23 Participants
Study participants will receive carvedilol for 12 weeks
Carvedilol: Carvedilol will be given for 12 weeks and then an exercise test will be performed
|
Placebo
n=23 Participants
Study participants will receive placebo (sugar pill) for 12 weeks
Placebo: Placebo will be given for 12 weeks and then an exercise test will be performed
|
|---|---|---|
|
Change in Peak Heart Rate
|
-32.3 beats per minute
Standard Deviation 24.2
|
1.9 beats per minute
Standard Deviation 12.6
|
SECONDARY outcome
Timeframe: on week 12 and week 30 of the studyduring exercise test on week 12 and week 30
Outcome measures
| Measure |
Carvedilol
n=23 Participants
Study participants will receive carvedilol for 12 weeks
Carvedilol: Carvedilol will be given for 12 weeks and then an exercise test will be performed
|
Placebo
n=23 Participants
Study participants will receive placebo (sugar pill) for 12 weeks
Placebo: Placebo will be given for 12 weeks and then an exercise test will be performed
|
|---|---|---|
|
Change in Oxygen Uptake at Anaerobic Threshold
|
-1.02 ml/kg/min
Standard Deviation 3.75
|
-1.78 ml/kg/min
Standard Deviation 4.55
|
Adverse Events
Carvedilol
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Carvedilol
n=25 participants at risk
Study participants will receive carvedilol for 12 weeks
Carvedilol: Carvedilol will be given for 12 weeks and then an exercise test will be performed
|
Placebo
n=24 participants at risk
Study participants will receive placebo (sugar pill) for 12 weeks
Placebo: Placebo will be given for 12 weeks and then an exercise test will be performed
|
|---|---|---|
|
Cardiac disorders
Bradycardia
|
16.0%
4/25 • Number of events 4 • 36 weeks
AE were classified as serious or non-serious also related to study drug or unrelated to study drug at the time of the study visit.
|
0.00%
0/24 • 36 weeks
AE were classified as serious or non-serious also related to study drug or unrelated to study drug at the time of the study visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place