Study of Tadalafil Vs. Placebo for Improving Hemodynamics and End-Organ Dysfunction in Fontan Physiology
- Registration Number
- NCT05206955
- Lead Sponsor
- Mayo Clinic
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Group Placebo Study participants will receive a placebo capsule that looks identical to the Tadalafil capsule. The placebo will be taken orally once daily for 52 weeks. Tadalafil Group Tadalafil Study participants will receive 10 mg of Tadalafil daily for 1 week, then 20 mg daily for 1 week, and finally 40 mg daily for 50 weeks for a total therapy time of 52 weeks. Tadalafil will be taken orally in capsule form once daily.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Renal function 52 weeks Measured by the glomerular filtration rate
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.
Liver stiffness 52 weeks Liver magnetic resonance elastography (MRE) will be used to assess liver stiffness expressed in Pascals (Pa)
Exercise capacity 52 weeks Assessed using peak VO2 (oxygen consumption) obtained from an upright treadmill or supine bike cardiopulmonary exercise test with echocardiogram
Trial Locations
- Locations (1)
Mayo Clinic
🇺🇸Rochester, Minnesota, United States