Mayo Clinic
Rochester, Minnesota, 55905, United States
Location status: Recruiting
Location contact
ACHD Research Team
CONTACT
Alexander C Egbe, MBBS, MPH
PRINCIPAL_INVESTIGATOR
Recruiting
NCT Number: NCT05206955
Study of Tadalafil vs. Placebo for Improving Hemodynamics and End-Organ Dysfunction in Fontan Physiology
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Tadalafil
Drug10 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
DrugLooks exactly like the study drug, but it contains no active ingredient
Primary outcomes
-
Microvascular endothelial function
Time frame: 52 weeks
Measured by the reactive hyperemic index using peripheral artery tonometry (EndoPAT)
-
Pulmonary vascular reserve
Time frame: 52 weeks
The slope of mean pulmonary artery pressure / cardiac output (mPAP/CO)
Secondary outcomes
-
Liver stiffness
Time frame: 52 weeks
Liver magnetic resonance elastography (MRE) will be used to assess liver stiffness expressed in Pascals (Pa)
-
Renal function
Time frame: 52 weeks
Measured by the glomerular filtration rate
-
Exercise capacity
Time frame: 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
Time frame: 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.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Mayo Clinic
Other
Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
Registry information
Official study 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)
Important dates
- Study start
- 2022
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Jan 25, 2022
- Registry last updated
- Nov 14, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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