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

Recruiting
18 years of age
Both
Phase 3
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Overview

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

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.

Study details

Fontan Palliation

NCT05206955

Mayo Clinic

25 January 2024

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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