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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
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Mezzion Pharma Co. Ltd

Study Description
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Brief Summary:
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 subjects who have undergone the Fontan procedure.

Condition or disease Intervention/treatment Phase
Single Ventricle Heart Disease Drug: Udenafil Drug: Placebo Phase 3

Detailed Description:
This study is a randomized, double-blinded, efficacy trial of the effects of udenafil vs. placebo on the background of standard therapy on maximal VO2 (ml/kg/min) from baseline to six months in adolescent survivors of the Fontan procedure. . The target sample size is 400 subjects (200 per group).
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Drug
Udenafil. One tablet twice daily for 26 weeks
 Drug: Udenafil
Active drug
Experimental: Placebo
Placebo. One tablet twice daily for 26 weeks
 Drug: Placebo
Matching Placebo


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion 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

Exclusion Criteria:

  1. Weight < 40 kg
  2. Height < 132 cm.
  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.
  9. VO2 less than 50%
  10. Severe ventricular dysfunction assessed qualitatively by clinical echocardiography within six months prior to enrollment.
  11. Severe valvar regurgitation, ventricular outflow obstruction, or aortic arch obstruction assessed by clinical echocardiography within six months prior to enrollment.
  12. 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.
  13. Inability to complete exercise testing at baseline screening.
  14. History of PDE-5 inhibitor use within 3 months before study onset.
  15. History of any other medication for treatment of pulmonary hypertension within 3 months before study onset.
  16. Known intolerance to oral udenafil.
  17. Frequent use of medications or other substances that inhibit or induce CYP3A4.
  18. Current use of alpha-blockers or nitrates.
  19. Ongoing or planned participation in another research protocol that would either prevent successful completion of planned study testing or invalidate its results.
  20. Noncardiac medical, psychiatric, and/or social disorder that would prevent successful completion of planned study testing or would invalidate its results.
  21. Cardiac care, ongoing or planned, at a non-study center that would impede study completion.
  22. 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.
  23. Unable to abstain or limit intake of grapefruit juice during the duration of the trial.
  24. Refusal to provide written informed consent/assent.
  25. In the opinion of the primary care physician, the subject is likely to be non-compliant with the study protocol.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
Mezzion Pharma Co. Ltd
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Steve Paridon, MD Children's Hospital of Phildelphia
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Mezzion Pharma Co. Ltd
ClinicalTrials.gov Identifier: NCT02741115    
Other Study ID Numbers: PHN-Udenafil-02
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mezzion Pharma Co. Ltd:
Fontan
Maximal Oxygen Consumption
Vascular Function
EndoPAT
Myocardial Performance
Additional relevant MeSH terms:
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Heart Diseases
Univentricular Heart
Cardiovascular Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities
 Udenafil
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action