Actively Recruiting
Study of Tadalafil vs. Placebo for Improving Hemodynamics and End-Organ Dysfunction in Fontan Physiology
Led by Mayo Clinic · Updated on 2025-11-14
80
Participants Needed
1
Research Sites
215 weeks
Total Duration
On this page
Sponsors
M
Mayo Clinic
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 undergone a Fontan Palliation.
CONDITIONS
Official Title
Study of Tadalafil vs. Placebo for Improving Hemodynamics and End-Organ Dysfunction in Fontan Physiology
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years or older
- Have previously undergone Fontan Palliation
- Able to exercise using a supine bike
- Able and willing to provide written consent
- Undergoing a clinically indicated Cardiac Catheterization
You will not qualify if you...
- Patients younger than 18 years
- Currently using intravenous inotropic drugs
- Currently using alpha-blockers, pulmonary vasodilators, or nitrates
- Unable to exercise
- Pregnant or breastfeeding
- Unable or unwilling to give consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
A
ACHD Research Team
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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