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

Fontan Palliation Clinical Trial

Official title:

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy of Tadalafil Versus Placebo in Improving Hemodynamics and End-Organ Dysfunction in Fontan Physiology (TRIUMPH Trial)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05206955
• Other study ID #: 21-009890
• Secondary ID: R01HL160761-01
• Status: Recruiting
• Phase: Phase 3
• Start date: September 16, 2022
• Est. completion date: February 28, 2027

Study information

• Verified date: November 2023
• Source: Mayo Clinic
• Contact: ACHD Research Team
• Phone: 507-293-2565
• Email: RSTACHDRESPRG[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: February 28, 2027
• Est. primary completion date: February 28, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

• Fontan Palliation

Intervention

Drug:
• Tadalafil
10 mg once daily orally week 1, 20 mg once daily orally during week 2, and 40 mg once daily orally during weeks 3 through 52
• Placebo
Looks exactly like the study drug, but it contains no active ingredient

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microvascular endothelial function	Measured by the reactive hyperemic index using peripheral artery tonometry (EndoPAT)	52 weeks
Primary	Pulmonary vascular reserve	The slope of mean pulmonary artery pressure / cardiac output (mPAP/CO)	52 weeks
Secondary	Liver stiffness	Liver magnetic resonance elastography (MRE) will be used to assess liver stiffness expressed in Pascals (Pa)	52 weeks
Secondary	Renal function	Measured by the glomerular filtration rate	52 weeks
Secondary	Exercise capacity	Assessed using peak VO2 (oxygen consumption) obtained from an upright treadmill or supine bike cardiopulmonary exercise test with echocardiogram	52 weeks
Secondary	Patient reported quality of life	Measured by the Minnesota Living with Heart Failure Questionnaire that asks subjects to rate how much their heart failure (heart condition) has affected their life during the past month (4 weeks) on a scale of 0=no and 5=very much.	52 weeks

External Links

•   Mayo Clinic Clinical Trials