RecruitingSingle Ventricle Heart Disease

Fontan Udenafil Exercise Longitudinal Assessment Trial - 2

Eligible age

12–18 yrs

Accepts

All genders

Locations

24 states

Healthy volunteers

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About this study

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.

Sponsor: Mezzion Pharma Co. Ltd

You may qualify if…

✓ 1. Males and females with Fontan physiology who are 12 to less than 19 years of age at enrollment.
✓ 2. Participant consent or parental/guardian consent and participant assent.
✓ 3. Participant fluency in primary language of country in which study is being conducted.
✓ 4. Current antiplatelet or anticoagulant therapy.

You may not qualify if…

✕ 1. Height \< 132 cm.
✕ 2. Weight \< 40 kg.
✕ 3. Hospitalization for acute decompensated heart failure within the last 12 months.
✕ 4. Current intravenous inotropic drugs.
✕ 5. Undergoing evaluation for heart transplantation or listed for transplantation.
✕ 6. Diagnosis of active protein losing enteropathy or plastic bronchitis within the last 3 years, or a history of liver cirrhosis.
✕ 7. 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.
✕ 8. Single lung physiology with greater than 80% flow to one lung.