Study of Tadalafil vs. Placebo for Improving Hemodynamics and End-Organ Dysfunction in Fontan Physiology

• Status: Recruiting
• Trial end date: 2027-02-01
• Target enrollment: 0
• Participant gender: All

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 undergone a Fontan Palliation.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Tadalafil

Criteria

Inclusion Criteria:

• Patients ≥ 18 years old.

• Have previously undergone a Fontan Palliation.

• Able to exercise using a supine bike.

• Able to undergo an MRI.

• Ability and willingness to provide written consent.

• Undergoing a clinically indicated Cardiac Catheterization

Exclusion Criteria:

• 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.