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New treatment option for Single Ventricle Heart Disease
Official title Fontan Udenafil Exercise Longitudinal Assessment Trial - 2
ClinicalTrials.gov ID: NCT05918211
What this study is testing
What is Udenafil?
Udenafil is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for single ventricle heart disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 18
You may be able to join 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 likely can't join 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.
See the full eligibility criteria
- 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.
- 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...
- 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...
- Inability to complete exercise testing at baseline screening.
- people 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.
- Refusal to provide written informed consent/assent.
- In the opinion of the investigator, the subject is likely to be non-compliant with the study protocol.
- History of clinically significant thromboembolic event, in the option of the site Principal Investigator, that may put the subject at increased risk of a subsequent event while participating in the study.
- Coronavirus disease 2019 (COVID-19) vaccination or symptoms of COVID-19 infection within 7 days of Visit 1.
- Not taking antiplatelet or anticoagulant therapy.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Little Rock, Arkansas, United States
- Los Angeles, California, United States
- San Diego, California, United States
- San Francisco, California, United States
- Denver, Colorado, United States
- New Haven, Connecticut, United States
- Wilmington, Delaware, United States
- Washington D.C., District of Columbia, United States
- Gainesville, Florida, United States
- Hollywood, Florida, United States
- St. Petersburg, Florida, United States
- Atlanta, Georgia, United States
- Augusta, Georgia, United States
- Chicago, Illinois, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Kansas City, Missouri, United States
- St Louis, Missouri, United States
- Omaha, Nebraska, United States
+ 17 more site(s).
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Little Rock, Arkansas, United States; Los Angeles, California, United States; San Diego, California, United States; San Francisco, California, United States; Denver, Colorado, United States and 31 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.