Status:
RECRUITING
Study of Tadalafil vs. Placebo for Improving Hemodynamics and End-Organ Dysfunction in Fontan Physiology
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Fontan Palliation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to find out more about the effectiveness of Tadalafil in improving hemodynamic capabilities, endothelial function, and end-organ function in patients who have previously u...
Eligibility Criteria
Inclusion
- Patients ≥ 18 years old.
- Have previously undergone a Fontan Palliation.
- Able to exercise using a supine bike.
- Ability and willingness to provide written consent.
- Undergoing a clinically indicated Cardiac Catheterization
Exclusion
- Patients \< 18 years old.
- Current intravenous inotropic drugs.
- Current use of alpha-blockers, pulmonary vasodilators, or nitrates.
- Unable to exercise.
- Pregnancy or lactating.
- Unable or unwilling to consent.
Key Trial Info
Start Date :
September 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05206955
Start Date
September 16 2022
End Date
November 1 2026
Last Update
November 14 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic
Rochester, Minnesota, United States, 55905