Fontan Udenafil Exercise Longitudinal Assessment Trial (FUEL)
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|ClinicalTrials.gov Identifier: NCT02741115|
Recruitment Status : Completed
First Posted : April 18, 2016
Last Update Posted : January 14, 2020
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|Condition or disease||Intervention/treatment||Phase|
|Single Ventricle Heart Disease||Drug: Udenafil Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Fontan Udenafil Exercise Longitudinal Assessment Trial (FUEL)|
|Actual Study Start Date :||July 22, 2016|
|Actual Primary Completion Date :||December 27, 2018|
|Actual Study Completion Date :||April 30, 2019|
Udenafil. One tablet twice daily for 26 weeks
Placebo. One tablet twice daily for 26 weeks
- Change in Exercise Capacity [ Time Frame: Baseline to 26 Weeks ]The change in exercise capacity (as measured by maximal VO2 at maximum exercise effort) from baseline to 26 weeks (or study completion)
- Change in Myocardial Performance Index (MPI) [ Time Frame: Baseline to 26 weeks ]The change in the myocardial performance index (MPI) from baseline to 26 weeks determined by velocities obtained from blood pool Doppler assessment of the inflow and outflow tract of the dominant ventricle.
- Change in log-transformed reactive hyperemia index (InRH) [ Time Frame: Baseline to 26 weeks ]The change in log-transformed reactive hyperemia index (lnRHI) from baseline to 26 weeks as measured by pulse amplitude tonometry (PAT) testing using the EndoPAT® device.
- Change in Level of Serum serum brain-type natriuretic peptide BNP [ Time Frame: Baseline to 26 weeks ]Change in Level of Serum serum brain-type natriuretic peptide BNP from baseline to 26 weeks.
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|Ages Eligible for Study:||12 Years to 18 Years (Child, Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02741115
|Principal Investigator:||Steve Paridon, MD||Children's Hospital of Phildelphia|
|Responsible Party:||Mezzion Pharma Co. Ltd|
|Other Study ID Numbers:||
U01HL068270 ( U.S. NIH Grant/Contract )
|First Posted:||April 18, 2016 Key Record Dates|
|Last Update Posted:||January 14, 2020|
|Last Verified:||January 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Maximal Oxygen Consumption
Heart Defects, Congenital
Phosphodiesterase 5 Inhibitors
Molecular Mechanisms of Pharmacological Action