Fontan Udenafil Exercise Longitudinal Assessment Trial

Completed · Phase 3 · Has a placebo group

Conditions studied: Single Ventricle Heart Disease

In brief

This study will evaluate the clinical efficacy and safety of udenafil, an orally administered, potent and selective inhibitor of PDE5, versus placebo for the treatment of adolescent subjects who have undergone the Fontan procedure.

Key facts

Study ID

NCT02741115

Run by

Mezzion Pharma Co. Ltd

People needed

400

Starts

2016-07-22

Expected to finish

2019-04-30

Last updated by the study team

2025-06-17

Who can join

Age: 12 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and females with Fontan physiology who are 12 to less than 19 years of age at enrollment.
• Participant consent or parental/guardian consent and participant assent
• Participant fluency in primary language of country in which study is being conducted

You may not qualify if…

• Weight < 40 kg
• Height < 132 cm.
• Hospitalization for acute decompensated heart failure within the last 12 months.
• Current intravenous inotropic drugs.
• Undergoing evaluation for heart transplantation or listed for transplantation.
• Diagnosis of active protein losing enteropathy or plastic bronchitis within the last 3 years, or a history of liver cirrhosis.
• Known Fontan baffle obstruction, branch pulmonary artery stenosis, or pulmonary vein stenosis resulting in a mean gradient of > 4 mmHg between the regions proximal and distal to the obstruction as measured by either catheterization or echocardiography, obtained prior to screening for the trial.
• Single lung physiology with greater than 80% flow to one lung.
• VO2 less than 50%
• Severe ventricular dysfunction assessed qualitatively by clinical echocardiography within six months prior to enrollment.
• Severe valvar regurgitation, ventricular outflow obstruction, or aortic arch obstruction assessed by clinical echocardiography within six months prior to enrollment.
• Significant renal (serum creatinine > 2.0), hepatic (serum AST and/or ALT > 3 times upper limit of normal), gastrointestinal or biliary disorders that could impair absorption, metabolism or excretion of orally administered medications, based on laboratory assessment six weeks prior to screening for the trial.
• Inability to complete exercise testing at baseline screening.
• History of PDE-5 inhibitor use within 3 months before study onset.
• History of any other medication for treatment of pulmonary hypertension within 3 months before study onset.
• Known intolerance to oral udenafil.
• Frequent use of medications or other substances that inhibit or induce CYP3A4.
• Current use of alpha-blockers or nitrates.
• Ongoing or planned participation in another research protocol that would either prevent successful completion of planned study testing or invalidate its results.
• Noncardiac medical, psychiatric, and/or social disorder that would prevent successful completion of planned study testing or would invalidate its results.
• Cardiac care, ongoing or planned, at a non-study center that would impede study completion.
• For females: Pregnancy at the time of screening, pregnancy planned before study completion, or refusal to use an acceptable method of contraception for study duration if sexually active.
• Unable to abstain or limit intake of grapefruit juice during the duration of the trial.
• Refusal to provide written informed consent/assent.
• In the opinion of the primary care physician, the subject is likely to be non-compliant with the study protocol.

Where it is running

• Phoenix Children's Hospital/Children's Heart Center at Phoenix Children's Hospital — Phoenix, Arizona, United States
• Children's Hospital Los Angeles — Los Angeles, California, United States
• Cedars/Sinai Heart Institute — Los Angeles, California, United States
• Rady Children's Hospital — San Diego, California, United States
• Children's Hospital Colorado — Aurora, Colorado, United States
• Nemours Cardiac Center/Alfred I. duPont Hospital for Children — Wilmington, Delaware, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Johns Hopkins All Children's Heart Institute — St. Petersburg, Florida, United States
• Children's Healthcare of Atlanta — Atlanta, Georgia, United States
• Riley Hospital for Children/Herman B. Wells Center for Pediatric Research — Indianapolis, Indiana, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• University of Michigan Congenital Heart Center/C.S. Mott Children's Hospital — Ann Arbor, Michigan, United States
• Children's Mercy Hospital Kansas City — Kansas City, Missouri, United States
• Washington University St. Louis/St.Louis Children's Hospital — St Louis, Missouri, United States
• University of Nebraska Children's Hospital and Medical Center — Omaha, Nebraska, United States
• Children's Hospital of New York — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Nationwide Children's Hosptial — Columbus, Ohio, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Texas Children's Hospital — Houston, Texas, United States
• Primary Children's Medical Hospital/Dept. of Pediatric Cardiology — Salt Lake City, Utah, United States
• Seattle Children's Hosptial — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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