Effect of Carvedilol on Exercise Performance in Fontan Patients
Sponsor: American Heart Association
A PHASE4 clinical study on Fontan and Single Ventricle, this trial is completed. The trial is conducted by American Heart Association and has accumulated 12 data snapshots since 2016. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.
Study Description(click to expand)Carvedilol is a well studied heart failure medication in adult heart failure that has been shown to improve outcomes. However, it has not been studied in patients who have had a Fontan heart operation. Study participants will receive either placebo or carvedilol for 12 weeks, at the end of the 12 weeks participants will perform an exercise test. Then study participants will receive treatment with placebo or carvedilol for 12 weeks (opposite of what participants go the first 12 weeks) and will again perform an exercise test.
Carvedilol is a well studied heart failure medication in adult heart failure that has been shown to improve outcomes. However, it has not been studied in patients who have had a Fontan heart operation. Study participants will receive either placebo or carvedilol for 12 weeks, at the end of the 12 weeks participants will perform an exercise test. Then study participants will receive treatment with placebo or carvedilol for 12 weeks (opposite of what participants go the first 12 weeks) and will again perform an exercise test.
Status Flow
Change History
12 versions recorded-
Jan 2026 — Present [monthly]
Completed PHASE4
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Sep 2024 — Present [monthly]
Completed PHASE4
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE4
-
Jan 2023 — Jul 2024 [monthly]
Completed PHASE4
-
Dec 2022 — Jan 2023 [monthly]
Completed PHASE4
▶ Show 7 earlier versions
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Feb 2021 — Dec 2022 [monthly]
Completed PHASE4
-
Jan 2021 — Feb 2021 [monthly]
Completed PHASE4
-
Mar 2020 — Jan 2021 [monthly]
Completed PHASE4
Status: Recruiting → Completed
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Mar 2019 — Mar 2020 [monthly]
Recruiting PHASE4
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Jun 2018 — Mar 2019 [monthly]
Recruiting PHASE4
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Jul 2017 — Jun 2018 [monthly]
Recruiting PHASE4
Status: Not Yet Recruiting → Recruiting
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Jan 2017 — Jul 2017 [monthly]
Not Yet Recruiting PHASE4
First recorded
Nov 2016
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- American Heart Association
- University of Texas Southwestern Medical Center
For direct contact, visit the study record on ClinicalTrials.gov .