Evidence map›Paper›PMID 31736357›Full record

Trial reportCirculation2020

Results of the FUEL Trial.

David J Goldberg, Victor Zak, Bryan H Goldstein, Kurt R Schumacher, Jonathan Rhodes, Daniel J Penny, Christopher J Petit, Salil Ginde, Shaji C Menon, Seong-Ho Kim and 33 more

Erratum issued Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Circulation, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT02741115 (Fontan Udenafil Exercise Longitudinal Assessment Trial), which is not on this map. Cited by 83 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
83citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02741115 phase3completednot on this map

Fontan Udenafil Exercise Longitudinal Assessment Trial (FUEL)

TypeinterventionalSponsorMezzion Pharma Co. LtdRan2016 to 2019Enrolled400ConditionsSingle Ventricle Heart DiseaseArmsUdenafil, Placebo
3 · Its place in the literature

Who cites it

83 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Article
  8. Article
  9. Changes in pharmacotherapy in adults with Fontan circulation and associations with outcomes.International journal of cardiology. Congenital heart disease · 2026
    Article
  10. Article
  11. Review
  12. Article
  13. Article
  14. Article
  15. Article
  16. Article
  17. Single Ventricle Fontan: The Basics for General Cardiologists.Methodist DeBakey cardiovascular journal · 2026
    Review
  18. Article
  19. Article
  20. Article

23 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

43 authors.

David J GoldbergDivision of Cardiology, The Children's Hospital of Philadelphia, Perelman School of Medicine, PA (D.J.G., S.W., M.G.M., S.M.P.).
Victor ZakNew England Research Institutes, Watertown, MA (V.Z.).
Bryan H GoldsteinDivision of Cardiology, Cincinnati Children's Hospital Medical Center, OH (B.H.G., M.S.H., K.A.R., E.M.U.).
Kurt R SchumacherDivision of Cardiology, C.S. Mott Children's Hospital, Ann Arbor, MI (K.R.S., M.W.R.).
Jonathan RhodesDepartment of Cardiology, Children's Hospital Boston, MA (J.R.).
Daniel J PennyDivision of Cardiology, Texas Children's Hospital, Baylor College of Medicine, Houston, TX (D.J.P.).
Christopher J PetitEmory University School of Medicine, Children's Healthcare of Atlanta, GA (C.J.P.).
Salil GindeDivision of Cardiology, Medical College of Wisconsin, Children's Hospital of Wisconsin, Milwaukee (S.G., P.C.F.).
Shaji C MenonDivision of Pediatric Cardiology, University of Utah, Salt Lake City (S.C.M.).
Seong-Ho KimDepartment of Pediatrics, Sejong General Hospital, Bucheon-Si, South Korea (S.-H.K.).
Gi Beom KimSeoul National University School of Medicine, Seoul National University Children's Hospital, South Korea (G.B.K.).
Todd T NowlenHeart Center, Phoenix Children's Hospital, AZ (T.T.N.).
Michael V DiMariaDepartment of Pediatrics, Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (M.V.D.).
Benjamin P FrischhertzDivision of Cardiology, Vanderbilt University School of Medicine, Nashville, TN (B.P.F.).
Jonathan B WagnerDivisions of Cardiology and Clinical Pharmacology, Children's Mercy Kansas City, MO (J.B.W.).
Kimberly E McHughDivision of Pediatric Cardiology, Medical University of South Carolina, Charleston (K.E.M.).
Brian W McCrindleDivision of Cardiology, The Hospital for Sick Children, University of Toronto, Ontario (B.W.M.).
Amanda J ShillingfordNemours Cardiac Center, Nemours/Alfred I. DuPont Hospital for Children, Wilmington, DE (A.J.S.).
Arash A SabatiLos Angeles Children's Hospital, Division of Cardiology, CA (A.A.S.).
Anji T YetmanChildren's Hospital and Medical Center, University of Nebraska, Omaha (A.T.Y.).
Anitha S JohnDivision of Cardiology, Children's National Health System, Washington, DC (A.S.J.).
Marc E RichmondDivision of Pediatric Cardiology, Morgan Stanley Children's Hospital, Columbia University Medical Center, New York, NY (M.E.R.).
Matthew D FilesDivision of Cardiology, Seattle Children's Hospital, WA (M.D.F.).
R Mark PayneDivision of Cardiology, Riley Hospital for Children, Indianapolis, IN (R.M.P.).
Andrew S MackieDivision of Cardiology, Stollery Children's Hospital, Edmonton, Alberta, Canada (A.S.M.).
Christopher K DavisDivision of Cardiology, Rady Children's Hospital, San Diego, CA (C.K.D.).
Shabana ShahanavazDivision of Cardiology, St Louis Children's Hospital, MO (S.S.).
Kevin D HillDuke Children's Pediatric and Congenital Heart Center, Durham, NC (K.D.H.).
Ruchira GargDivision of Cardiology, Cedars-Sinai Medical Center, Los Angeles, CA (R.G.).
Jeffrey P JacobsJohns Hopkins All Children's Hospital, Department of Surgery, St Petersburg, FL (J.P.J.).
Michelle S HamstraDivision of Cardiology, Cincinnati Children's Hospital Medical Center, OH (B.H.G., M.S.H., K.A.R., E.M.U.).
Stacy WoyciechowskiDivision of Cardiology, The Children's Hospital of Philadelphia, Perelman School of Medicine, PA (D.J.G., S.W., M.G.M., S.M.P.).
Kathleen A RathgeDivision of Cardiology, Cincinnati Children's Hospital Medical Center, OH (B.H.G., M.S.H., K.A.R., E.M.U.).
Michael G McBrideDivision of Cardiology, The Children's Hospital of Philadelphia, Perelman School of Medicine, PA (D.J.G., S.W., M.G.M., S.M.P.).
Peter C FrommeltDivision of Cardiology, Medical College of Wisconsin, Children's Hospital of Wisconsin, Milwaukee (S.G., P.C.F.).
Mark W RussellDivision of Cardiology, C.S. Mott Children's Hospital, Ann Arbor, MI (K.R.S., M.W.R.).
Elaine M UrbinaDivision of Cardiology, Cincinnati Children's Hospital Medical Center, OH (B.H.G., M.S.H., K.A.R., E.M.U.).
James L YeagerConsultant to Mezzion Pharma Co Ltd, Mezzion Pharma Co Ltd, Seoul, South Korea (J.L.Y.).
Victoria L PembertonDivision of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (V.L.P., M.P.S., G.D.P.).
Mario P StylianouDivision of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (V.L.P., M.P.S., G.D.P.).
Gail D PearsonDivision of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (V.L.P., M.P.S., G.D.P.).
Stephen M ParidonDivision of Cardiology, The Children's Hospital of Philadelphia, Perelman School of Medicine, PA (D.J.G., S.W., M.G.M., S.M.P.).
Pediatric Heart Network Investigators

Funding

Pediatric Heart network DCCU10HL068270 · NHLBI · NEW ENGLAND RESEARCH INSTITUTES, INC. · PI MILLER, JULIE ELAINE, TRACHTENBERG, FELICIA LYNN · 2011 to 2016
$44.9M
MIS-C Program: Data Coordinating Center for the Pediatric Heart Network MIS-C ProgramU24HL135691 · NHLBI · NEW ENGLAND RESEARCH INSTITUTES, INC. · PI MILLER, JULIE ELAINE, TRACHTENBERG, FELICIA LYNN · 2017 to 2024
$37.9M
Institutional Career Development CoreKL2TR002367 · NCATS · UNIVERSITY OF KANSAS MEDICAL CENTER · PI MATTHEW W MOSCONI, NICOLE L NOLLEN · 2017 to 2026
$7.3M
Pediatric Heart Network Clinical Research Centers - Boston Children's HospitalUG1HL135685 · NHLBI · BOSTON CHILDREN'S HOSPITAL · PI NEWBURGER, JANE W., TRIEDMAN, JOHN K · 2017 to 2023
$2.7M
Sidenafil Impacts Exercise Performance in Adolescent Survivors of the FontanU10HL109818 · NHLBI · CHILDREN'S HOSP OF PHILADELPHIA · PI GAYNOR, JAMES WILLIAM, PARIDON, STEPHEN · 2011 to 2015
$2.7M
Pediatric Heart Network Children's Hospital of PhiladelphiaUG1HL135683 · NHLBI · CHILDREN'S HOSP OF PHILADELPHIA · PI GAYNOR, JAMES WILLIAM, GOLDBERG, DAVID J · 2017 to 2023
$2.6M
Baylor/Texas Children's Hospital Pediatric Heart NetworkUG1HL135666 · NHLBI · BAYLOR COLLEGE OF MEDICINE · PI HEINLE, JEFFREY STEPHEN, PENNY, DANIEL J · 2017 to 2023
$2.4M
Pediatric Heart Network Prairieland ConsortiumUG1HL135678 · NHLBI · CINCINNATI CHILDRENS HOSP MED CTR · PI CNOTA, JAMES, PAYNE, RONALD MARK · 2017 to 2023
$2.4M
Pediatric Heart Network Regents of the University of MichiganUG1HL135665 · NHLBI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI GOLDBERG, CAREN S, OHYE, RICHARD G · 2017 to 2023
$2.4M
Pediatric Heart Network - Utah CenterUG1HL135646 · NHLBI · UNIVERSITY OF UTAH · PI MINICH, L. LUANN, WILLIAMS, RICHARD VINCENT · 2017 to 2023
$2.3M
Pediatric Heart Network Prairieland ConsortiumU10HL109673 · NHLBI · CINCINNATI CHILDRENS HOSP MED CTR · PI CNOTA, JAMES, PAYNE, RONALD MARK · 2011 to 2015
$2.3M
Pediatric Heart Network Clinical Research Center - Medical University of South CarolinaUG1HL135689 · NHLBI · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI ATZ, ANDREW M, GRAHAM, ERIC M. · 2017 to 2023
$2.3M
NCATS NIH HHS KL2 TR002367NHLBI NIH HHS U10 HL068270NHLBI NIH HHS U10 HL109673NHLBI NIH HHS U10 HL109818NHLBI NIH HHS U24 HL135691NHLBI NIH HHS UG1 HL135646NHLBI NIH HHS UG1 HL135665NHLBI NIH HHS UG1 HL135666NHLBI NIH HHS UG1 HL135678NHLBI NIH HHS UG1 HL135680NHLBI NIH HHS UG1 HL135682NHLBI NIH HHS UG1 HL135683NHLBI NIH HHS UG1 HL135685NHLBI NIH HHS UG1 HL135689NHLBI NIH HHS UM1 HL172717
6 · The paper itself

Abstract

backgroundThe Fontan operation creates a total cavopulmonary connection, a circulation in which the importance of pulmonary vascular resistance is magnified. Over time, this circulation leads to deterioration of cardiovascular efficiency associated with a decline in exercise performance. Rigorous clinical trials aimed at improving physiology and guiding pharmacotherapy are lacking.

methodsThe FUEL trial (Fontan Udenafil Exercise Longitudinal) was a phase III clinical trial conducted at 30 centers. Participants were randomly assigned udenafil, 87.5 mg twice daily, or placebo in a 1:1 ratio. The primary outcome was the between-group difference in change in oxygen consumption at peak exercise. Secondary outcomes included between-group differences in changes in submaximal exercise at the ventilatory anaerobic threshold, the myocardial performance index, the natural log of the reactive hyperemia index, and serum brain-type natriuretic peptide.

resultsBetween 2017 and 2019, 30 clinical sites in North America and the Republic of Korea randomly assigned 400 participants with Fontan physiology. The mean age at randomization was 15.5±2 years; 60% of participants were male, and 81% were white. All 400 participants were included in the primary analysis with imputation of the 26-week end point for 21 participants with missing data (11 randomly assigned to udenafil and 10 to placebo). Among randomly assigned participants, peak oxygen consumption increased by 44±245 mL/min (2.8%) in the udenafil group and declined by 3.7±228 mL/min (-0.2%) in the placebo group (

conclusionsIn the FUEL trial, treatment with udenafil (87.5 mg twice daily) was not associated with an improvement in oxygen consumption at peak exercise but was associated with improvements in multiple measures of exercise performance at the ventilatory anaerobic threshold. CLINICAL

trial registrationURL: https://www.clinicaltrials.gov. Unique identifier: NCT02741115.

Indexed as

AdolescentBenzenesulfonamidesChildDouble-Blind MethodDrug Administration ScheduleExerciseFemaleFontan ProcedureHeart DiseasesHeart RateHumansMaleNatriuretic Peptide, BrainOxygen ConsumptionPhosphodiesterase 5 InhibitorsPlacebo EffectBenzenesulfonamidesNatriuretic Peptide, BrainPhosphodiesterase 5 InhibitorsPyrimidinesSulfonamidesudenafilexercise testFontan procedureheart defects, congenitalphosphodiesterase 5 inhibitor

Identifiers

PMID31736357
PMCPMC7042084

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.