At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 26 enrolled
Drug / intervention
Carvedilol +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Effect of Carvedilol on Exercise Performance in Fontan Patients
University of Texas Southwestern Medical Center·interventional·Posted Oct 27, 2016·Updated Jan 22, 2021
In Brief
A Phase 4 clinical trial evaluating Carvedilol and Placebo for Single Ventricle and Fontan. Completed, enrolled 26 participants across 1 site.
Detailed Summary
This study evaluates the effect of carvedilol in patients who have undergone a Fontan heart operation. All participants will receive carvedilol and placebo for 12 weeks. Exercise tests will be performed at the end of each 12 week period.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSingle Ventricle, Fontan
CountriesUnited States
CollaboratorsAmerican Heart Association
Timeline
Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedOct 2016
Enrollment StartNov 2016
Primary CompletionDec 2019
Study CompletionJan 2020
TodayJul 2026
First PostedOct 27, 2016
Enrollment StartNov 1, 2016
Primary CompletionDec 1, 2019
Study CompletionJan 1, 2020
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 9.7 years ago
Interventions
Carvediloldrug
Carvedilol will be given for 12 weeks and then an exercise test will be performed
Placebodrug
Placebo will be given for 12 weeks and then an exercise test will be performed