RECRUITING

Fontan Udenafil Exercise Longitudinal Assessment Trial - 2

Conditions

Single Ventricle Heart Disease Fontan Maximal Oxygen Consumption Work Rate VO2 at VAT Ventilatory Efficiency

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Fontan Udenafil Exercise Longitudinal Assessment Trial (FUEL-2)

Quick Facts

Study Start:2023-10-30

Study Completion:2025-10-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05918211

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
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.	1. Height \< 132 cm. 2. Hospitalization for acute decompensated heart failure within the last 12 months. 3. Current intravenous inotropic drugs. 4. Undergoing evaluation for heart transplantation or listed for transplantation. 5. Diagnosis of active protein losing enteropathy or plastic bronchitis within the last 3 years, or a history of liver cirrhosis. 6. 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. 7. Single lung physiology with greater than 80% flow to one lung. 8. Peak minute oxygen consumption (VO2) less than 45% or ≥ 80% of predicated for age and gender at enrollment. 9. Severe ventricular dysfunction assessed qualitatively by clinical echocardiography within 6 months prior to enrollment. 10. Severe valvar regurgitation, ventricular outflow obstruction, or severe aortic arch obstruction assessed by clinical echocardiography within six months prior to enrollment. 11. 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. 12. Inability to complete exercise testing at baseline screening. 13. History of PDE-5 inhibitor use within 12 months prior to enrollment. 14. History of any other medication for treatment of pulmonary hypertension within 3 months before study onset. 15. Known intolerance to oral udenafil. 16. Frequent use of medications or other substances that inhibit or induce CYP3A4. 17. Current use of alpha-blockers or nitrates. 18. Ongoing or planned participation in another research protocol that would either prevent successful completion of planned study testing or invalidate its results. 19. Noncardiac medical, psychiatric, and/or social disorder that would prevent successful completion of planned study testing or would invalidate its results. 20. Cardiac care, ongoing or planned, at a non-study center that would impede study completion. 21. 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. 22. Unable to abstain or limit intake of grapefruit juice and grapefruit containing drinks during the duration of the trial. 23. Refusal to provide written informed consent/assent. 24. In the opinion of the investigator, the subject is likely to be non-compliant with the study protocol. 25. 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. 26. Coronavirus disease 2019 (COVID-19) vaccination or symptoms of COVID-19 infection within 7 days of Visit 1. 27. Not taking antiplatelet or anticoagulant therapy.

Inclusion Criteria

Exclusion Criteria

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.

1. Height \< 132 cm.
2. Hospitalization for acute decompensated heart failure within the last 12 months.
3. Current intravenous inotropic drugs.
4. Undergoing evaluation for heart transplantation or listed for transplantation.
5. Diagnosis of active protein losing enteropathy or plastic bronchitis within the last 3 years, or a history of liver cirrhosis.
6. 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.
7. Single lung physiology with greater than 80% flow to one lung.
8. Peak minute oxygen consumption (VO2) less than 45% or ≥ 80% of predicated for age and gender at enrollment.
9. Severe ventricular dysfunction assessed qualitatively by clinical echocardiography within 6 months prior to enrollment.
10. Severe valvar regurgitation, ventricular outflow obstruction, or severe aortic arch obstruction assessed by clinical echocardiography within six months prior to enrollment.
11. 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.
12. Inability to complete exercise testing at baseline screening.
13. History of PDE-5 inhibitor use within 12 months prior to enrollment.
14. History of any other medication for treatment of pulmonary hypertension within 3 months before study onset.
15. Known intolerance to oral udenafil.
16. Frequent use of medications or other substances that inhibit or induce CYP3A4.
17. Current use of alpha-blockers or nitrates.
18. Ongoing or planned participation in another research protocol that would either prevent successful completion of planned study testing or invalidate its results.
19. Noncardiac medical, psychiatric, and/or social disorder that would prevent successful completion of planned study testing or would invalidate its results.
20. Cardiac care, ongoing or planned, at a non-study center that would impede study completion.
21. 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.
22. Unable to abstain or limit intake of grapefruit juice and grapefruit containing drinks during the duration of the trial.
23. Refusal to provide written informed consent/assent.
24. In the opinion of the investigator, the subject is likely to be non-compliant with the study protocol.
25. 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.
26. Coronavirus disease 2019 (COVID-19) vaccination or symptoms of COVID-19 infection within 7 days of Visit 1.
27. Not taking antiplatelet or anticoagulant therapy.

Contacts and Locations

Study Contact

John Hariadi, MD

CONTACT

443.699.6746

john.hariadi@mezzion.com

Kelly R Williams, BS

CONTACT

573.434.2579

kelly.williams@mezzion.com

Principal Investigator

John Hariadi, MD

STUDY_DIRECTOR

Mezzion Pharma Co. Ltd

Study Locations (Sites)

Phoenix Children's Hospital

Phoenix, Arizona, 85016

United States

Children's Hospital of Los Angeles

Los Angeles, California, 90027

United States

Children's Hospital of Colorado

Denver, Colorado, 80045

United States

Yale School of Medicine

New Haven, Connecticut, 06510

United States

Childrens National Medical Center

Washington, District of Columbia, 20010

United States

UF Health Shands Hospital

Gainesville, Florida, 32608

United States

Joe DiMaggio Children's Hospital

Hollywood, Florida, 33021

United States

Johns Hopkins All Children's Hospital

Saint Petersburg, Florida, 33701

United States

Children's Healthcare of Atlanta

Atlanta, Georgia, 30329

United States

Children's Hospital of Georgia

Augusta, Georgia, 30912

United States

University of Chicago

Chicago, Illinois, 60637

United States

Boston Children's Hospital

Boston, Massachusetts, 02115

United States

University of Michigan

Ann Arbor, Michigan, 48109

United States

Children's Mercy Hospital Kansas City

Kansas City, Missouri, 64108

United States

Washington University

Saint Louis, Missouri, 63130

United States

University of Nebraska Children's Hospital and Medical Center

Omaha, Nebraska, 68114

United States

New York-Presbyterian Children's Hospital

New York, New York, 10032

United States

Duke University Medical Center

Durham, North Carolina, 27710

United States

Cincinnati Childrens Hospital Medical Center

Cincinnati, Ohio, 45206

United States

Cleveland Clinic

Cleveland, Ohio, 44195

United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104

United States

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224

United States

MUSC Pediatric Research Group

Charleston, South Carolina, 29425

United States

Vanderbilt University Medical Center

Nashville, Tennessee, 37232

United States

Texas Children's Hospital

Houston, Texas, 77030

United States

Primary Children's Medical Center

Salt Lake City, Utah, 84113

United States

Seattle Children's Hospital

Seattle, Washington, 98105

United States

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226

United States

Collaborators and Investigators

Sponsor: Mezzion Pharma Co. Ltd

John Hariadi, MD, STUDY_DIRECTOR, Mezzion Pharma Co. Ltd

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-30

Study Completion Date2025-10-28

Study Record Updates

Study Start Date2023-10-30

Study Completion Date2025-10-28

Terms related to this study

Keywords Provided by Researchers

Fontan
Maximal Oxygen Consumption
Work Rate
VO2 at VAT
Ventilatory Efficiency

Additional Relevant MeSH Terms

Single Ventricle Heart Disease