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

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)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05206955

Enrollment

Registered

2022-01-25

Start date

2022-09-16

Completion date

2026-11-01

Last updated

2026-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fontan Palliation

Brief 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.

Interventions

DRUGTadalafil

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

DRUGPlacebo

Looks exactly like the study drug, but it contains no active ingredient

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Microvascular endothelial function	52 weeks	Measured by the reactive hyperemic index using peripheral artery tonometry (EndoPAT)
Pulmonary vascular reserve	52 weeks	The slope of mean pulmonary artery pressure / cardiac output (mPAP/CO)

Secondary

Measure	Time frame	Description
Liver stiffness	52 weeks	Liver magnetic resonance elastography (MRE) will be used to assess liver stiffness expressed in Pascals (Pa)
Renal function	52 weeks	Measured by the glomerular filtration rate
Exercise capacity	52 weeks	Assessed using peak VO2 (oxygen consumption) obtained from an upright treadmill or supine bike cardiopulmonary exercise test with echocardiogram
Patient reported quality of life	52 weeks	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.

Countries

United States

Contacts

CONTACTACHD Research Team

RSTACHDRESPRG@mayo.edu507-293-2565

PRINCIPAL_INVESTIGATORAlexander C Egbe, MBBS, MPH

Mayo Clinic

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 14, 2026