Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT05206955

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Mayo Clinic

Rochester, Minnesota, United States, 55905

Actively Recruiting

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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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