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NCT05206955
Study of Tadalafil vs. Placebo for Improving Hemodynamics and End-Organ Dysfunction in Fontan Physiology
Conditions: Fontan Palliation
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 42
Sponsor: Mayo Clinic
Location: Mayo Clinic Rochester Minnesota
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.
Eligibility Criteria
Inclusion Criteria:
* 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 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.
Source: ClinicalTrials.gov (NCT05206955). StuddyBuddy aggregates publicly available trial information.
