Fontan Udenafil Exercise Longitudinal Assessment Trial - 2

Recruiting now · 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 who have had the Fontan procedure.

Key facts

Study ID

NCT05918211

Run by

Mezzion Pharma Co. Ltd

People needed

436

Starts

2023-10-30

Expected to finish

2025-10-28

Last updated by the study team

2025-10-28

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.
• Current antiplatelet or anticoagulant therapy.

You may not qualify if…

• Height < 132 cm.
• Weight < 40 kg.
• 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.
• Failure to achieve maximal exertion (defined as RER < 1.10) on screening/baseline exercise test.
• Peak minute oxygen consumption (VO2) less than 45% or ≥ 80% of predicated for age and gender at enrollment.
• Severe ventricular dysfunction assessed qualitatively by clinical echocardiography within 6 months prior to enrollment.
• Severe valvar regurgitation, ventricular outflow obstruction, or severe aortic arch obstruction assessed by clinical echocardiography within six months prior to enrollment.
• History of 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.
• Inability to complete exercise testing at baseline screening.
• Subjects with a pacemaker whose heart rate at peak exercise is controlled by the extrinsic pacemaker as opposed to a native atrial rhythm.
• History of PDE-5 inhibitor use within 12 months prior to enrollment. (Treatment is defined as chronic therapy as opposed to a single dose.)
• 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 and grapefruit containing drinks during the duration of the trial.

Where it is running

• Yonsei Severance Hospital — Seoul, South Korea (enrolling)
• Arkansas Children's — Little Rock, Arkansas, United States (enrolling)
• Children's Hospital of Los Angeles — Los Angeles, California, United States (enrolling)
• Rady Children's Hospital — San Diego, California, United States (enrolling)
• UCSF Benioff Children's Hospital — San Francisco, California, United States (enrolling)
• Children's Hospital of Colorado — Denver, Colorado, United States (enrolling)
• Yale School of Medicine — New Haven, Connecticut, United States (enrolling)
• Nemours Children's Hospital — Wilmington, Delaware, United States (enrolling)
• Childrens National Medical Center — Washington D.C., District of Columbia, United States (enrolling)
• UF Health Shands Hospital — Gainesville, Florida, United States (enrolling)
• Joe DiMaggio Children's Hospital — Hollywood, Florida, United States (enrolling)
• Johns Hopkins All Children's Hospital — St. Petersburg, Florida, United States (enrolling)
• Children's Healthcare of Atlanta — Atlanta, Georgia, United States (enrolling)
• Children's Hospital of Georgia — Augusta, Georgia, United States (enrolling)
• Lurie Children's Hospital — Chicago, Illinois, United States (enrolling)
• University of Chicago — Chicago, Illinois, United States (enrolling)
• Boston Children's Hospital — Boston, Massachusetts, United States (enrolling)
• University of Michigan — Ann Arbor, Michigan, United States (enrolling)
• Children's Mercy Hospital Kansas City — Kansas City, Missouri, United States (enrolling)
• Washington University — St Louis, Missouri, United States (enrolling)
• University of Nebraska Children's Hospital and Medical Center — Omaha, Nebraska, United States (enrolling)
• Seoul National University Children's Hospital — Seoul, South Korea (enrolling)
• Phoenix Children's Hospital — Phoenix, Arizona, United States (enrolling)
• New York-Presbyterian Children's Hospital — New York, New York, United States (enrolling)
• Duke University Medical Center — Durham, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.