Actively Recruiting
Fontan Udenafil Exercise Longitudinal Assessment Trial (FUEL-2)
Led by Mezzion Pharma Co. Ltd · Updated on 2025-10-28
436
Participants Needed
40
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the clinical efficacy and safety of udenafil, an oral drug that selectively inhibits PDE5, compared to a placebo in adolescents who have undergone the Fontan procedure for single ventricle heart disease. This Phase 3, randomized, double-blind, placebo-controlled study aims to measure improvements in exercise capacity and other health markers over 26 weeks. The study focuses on participants aged 12 to less than 19 years with Fontan physiology and is sponsored by Mezzion Pharma Co. Ltd. Participants will be randomly assigned to receive either udenafil or a matching placebo over the 26-week study period. Approximately 218 subjects will receive udenafil and another 218 will receive placebo across about 30 study sites. The main measurement will be the change in peak oxygen consumption during maximal cardiopulmonary exercise testing. Secondary assessments will include changes in ventilatory efficiency, liver fibrosis score, and exercise work rate. During the study, participants will undergo cardiopulmonary exercise tests and other evaluations to monitor respiratory and cardiovascular function, liver health, and exercise capacity. Researchers will track safety and adherence while blinded to treatment assignments. The primary outcome is the change in exercise capacity after 26 weeks. Participants' health and safety will be monitored throughout, with study visits and assessments planned at baseline and follow-up intervals over the 26-week duration.
CONDITIONS
Brief Title
Fontan Udenafil Exercise Longitudinal Assessment Trial - 2
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females with Fontan physiology aged 12 to less than 19 years at enrollment
- Participant consent or parental/guardian consent and participant assent
- Participant is fluent in the primary language of the country where the study is conducted
- Currently receiving antiplatelet or anticoagulant therapy
You will not qualify if you...
- Height less than 132 cm
- Weight less than 40 kg
- Hospitalization for acute decompensated heart failure within the last 12 months
- Current use of intravenous inotropic drugs
- Undergoing evaluation for or listed for heart transplantation
- Diagnosis of active protein losing enteropathy or plastic bronchitis within the last 3 years, or history of liver cirrhosis
- Known Fontan baffle obstruction, branch pulmonary artery stenosis, or pulmonary vein stenosis with mean gradient greater than 4 mmHg
- Single lung physiology with over 80% blood flow to one lung
- Failure to achieve maximal exertion (RER less than 1.10) on baseline exercise test
- Peak oxygen consumption less than 45% or greater than or equal to 80% of predicted for age and gender at enrollment
- Severe ventricular dysfunction or severe valvar regurgitation, ventricular outflow obstruction, or severe aortic arch obstruction within 6 months prior to enrollment
- History of significant renal, hepatic, gastrointestinal, or biliary disorders affecting medication processing
- Inability to complete exercise testing at baseline screening
- Pacemaker-dependent heart rate at peak exercise
- Use of PDE-5 inhibitors within 12 months prior to enrollment
- Use of other pulmonary hypertension medications within 3 months before study
- Known intolerance to oral udenafil
- Frequent use of medications or substances affecting CYP3A4 enzyme
- Current use of alpha-blockers or nitrates
- Participation in another conflicting research protocol
- Noncardiac medical, psychiatric, or social disorders preventing study completion
- Cardiac care at a non-study center impeding completion
- For females: pregnancy, planned pregnancy, or refusal to use contraception if sexually active
- Inability to abstain from grapefruit juice during the trial
- Refusal to provide informed consent/assent
- Likely non-compliance with study protocol
- History of clinically significant thromboembolic events
- COVID-19 vaccination or symptoms within 7 days of first visit
- Not taking antiplatelet or anticoagulant therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 26 weeks
Participants receive either udenafil or placebo as part of the study treatment to evaluate the effect on exercise capacity.
Regular visits during treatment as scheduled by the study team
Trial Site Locations
Total: 40 locations
1
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
Actively Recruiting
2
Arkansas Children's
Little Rock, Arkansas, United States, 72202
Actively Recruiting
3
Children's Hospital of Los Angeles
Los Angeles, California, United States, 90027
Actively Recruiting
4
Rady Children's Hospital
San Diego, California, United States, 92123
Actively Recruiting
5
UCSF Benioff Children's Hospital
San Francisco, California, United States, 94158
Actively Recruiting
6
Children's Hospital of Colorado
Denver, Colorado, United States, 80045
Actively Recruiting
7
Yale School of Medicine
New Haven, Connecticut, United States, 06510
Actively Recruiting
8
Nemours Children's Hospital
Wilmington, Delaware, United States, 19803
Actively Recruiting
9
Childrens National Medical Center
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
10
UF Health Shands Hospital
Gainesville, Florida, United States, 32608
Actively Recruiting
11
Joe DiMaggio Children's Hospital
Hollywood, Florida, United States, 33021
Actively Recruiting
12
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, United States, 33701
Actively Recruiting
13
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30329
Actively Recruiting
14
Children's Hospital of Georgia
Augusta, Georgia, United States, 30912
Actively Recruiting
15
Lurie Children's Hospital
Chicago, Illinois, United States, 60611
Actively Recruiting
16
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
17
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
18
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
19
Children's Mercy Hospital Kansas City
Kansas City, Missouri, United States, 64108
Actively Recruiting
20
Washington University
St Louis, Missouri, United States, 63130
Actively Recruiting
21
University of Nebraska Children's Hospital and Medical Center
Omaha, Nebraska, United States, 68114
Actively Recruiting
22
Mt. Sinai Children's Hospital
New York, New York, United States, 10029
Not Yet Recruiting
23
New York-Presbyterian Children's Hospital
New York, New York, United States, 10032
Actively Recruiting
24
Dana.Amaro@atriumhealth.org
Charlotte, North Carolina, United States, 28204
Not Yet Recruiting
25
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
26
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, United States, 45206
Actively Recruiting
27
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
28
Nationwide Children's Hospital
Columbus, Ohio, United States, 43215
Actively Recruiting
29
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
30
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
31
MUSC Pediatric Research Group
Charleston, South Carolina, United States, 29425
Actively Recruiting
32
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
33
UT Southwestern Medical Center
Dallas, Texas, United States, 75235
Actively Recruiting
34
Texas Children's Hospital
Houston, Texas, United States, 77030
Actively Recruiting
35
Primary Children's Medical Center
Salt Lake City, Utah, United States, 84113
Actively Recruiting
36
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Actively Recruiting
37
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
38
Sejong General Hospital
Bucheon-si, Gyeonggi-do, South Korea, 14754
Actively Recruiting
39
Seoul National University Children's Hospital
Seoul, South Korea, 03080
Actively Recruiting
40
Yonsei Severance Hospital
Seoul, South Korea, 03722
Actively Recruiting
Research Team
W
WG Kim
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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