Evidence map›Paper›PMID 36378780›Full record

Trial reportCirculation. Cardiovascular imaging2022

Impact of Udenafil on Echocardiographic Indices of Single Ventricle Size and Function in FUEL Study Participants.

Michael V Di Maria, David J Goldberg, Victor Zak, Chenwei Hu, Adam M Lubert, Andreea Dragulescu, Andrew S Mackie, Andrew McCrary, Angela Weingarten, Anitha Parthiban and 26 more

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Circulation. Cardiovascular imaging, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02741115 (Fontan Udenafil Exercise Longitudinal Assessment Trial), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.9field-weighted citation impact, top 25% of its field
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

4 citing papers in PubMed, 6 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

36 authors at 20 institutions in 3 countries.

Michael V Di MariaChildren's Hospital Colorado, University of Colorado School of Medicine, Aurora, CO (M.V.D.M.).ORCID 0000-0003-0346-8517
David J GoldbergChildren's Hospital of Philadelphia, University of Pennsylvania School of Medicine, Philadelphia, PA (D.J.G., S.M.P.).
Victor ZakHealthcore, Watertown, MA (V.Z., C.H.).
Chenwei HuHealthcore, Watertown, MA (V.Z., C.H.).
Adam M LubertCincinnati Children's Hospital, Heart Institute, Department of Pediatrics, University of Cincinnati College of Medicine, OH (A.M., B.H.G., E.M.U.).ORCID 0000-0001-6401-9980
Andreea DragulescuHospital for Sick Children, Toronto, Ontario, Canada (A.D.).
Andrew S MackieStollery Children's Hospital, University of Alberta, Edmonton, Canada (A.S.M.).
Andrew McCraryDuke University, Durham, NC (A.M.C.).
Angela WeingartenVanderbilt Heart and Vascular Institute, Nashville, TN (A.W.).ORCID 0000-0001-5712-6470
Anitha ParthibanTexas Children's Hospital, Baylor College of Medicine, Houston, TX (A.P., P.E.).
Benjamin GootChildren's Hospital of Wisconsin, Medical College of Wisconsin, Milwaukee, WI (B.G., M.S., P.C.F.).
Bryan H GoldsteinCincinnati Children's Hospital, Heart Institute, Department of Pediatrics, University of Cincinnati College of Medicine, OH (A.M., B.H.G., E.M.U.).ORCID 0000-0001-8508-9523
Carolyn TaylorShawn Jenkins Children's Hospital, Medical University of South Carolina, Charleston, SC (C.T.).
Christopher LindbladePhoenix Children's Hospital, University of Arizona, Phoenix, AZ (C.L.).ORCID 0000-0001-9173-2458
Christopher J PetitChildren's Heart Center, Emory University School of Medicine, Atlanta, GA (C.J.P.).ORCID 0000-0002-9939-3048
Christopher SpurneyChildren's National Hospital, Washington, DC (C.S.).
David M HarrildBoston Children's Hospital, MA (D.M.H.).
Elaine M UrbinaCincinnati Children's Hospital, Heart Institute, Department of Pediatrics, University of Cincinnati College of Medicine, OH (A.M., B.H.G., E.M.U.).ORCID 0000-0002-5640-6777
Eleanor SchuchardtRady Children's Hospital, University of California San Diego, CA (E.S.).ORCID 0000-0002-9106-8486
Gi Beom KimSeoul National University Children's Hospital, Seoul National University College of Medicine, South Korea (G.B.K.).
Ja Kyoung YoonSejong Hospital Cardiovascular Center, Department of Pediatrics, Bucheon, South Korea (J.K.Y.).ORCID 0000-0002-6104-5259
Jamie N ColomboSt. Louis Children's Hospital, Washington University School of Medicine, St Louis, MO (J.N.C.).
Matthew D FilesSeattle Children's Hospital, University of Washington, Seattle, WA (M.D.F.).
Megan SchoesslingChildren's Hospital of Wisconsin, Medical College of Wisconsin, Milwaukee, WI (B.G., M.S., P.C.F.).
Peter ErmisTexas Children's Hospital, Baylor College of Medicine, Houston, TX (A.P., P.E.).
Pierre C WongChildren's Hospital of Los Angeles, Keck School of Medicine of USC, Los Angeles, CA (P.C.W.).ORCID 0000-0003-3794-5887
Ruchira GargSmidt Heart Institute, Cedars-Sinai, Los Angeles, CA (R.G.).
Sara K SwansonChildren's Hospital and Medical Center, Omaha, NE (S.K.S.).
Shaji C MenonPrimary Children's Hospital, University of Utah, Salt Lake City, UT (S.C.M.).
Shubhika SrivastavaNemours, AI DuPont, Wilmington, DE (S.S.).
Thor ThorssonC.S. Mott Children's Hospital, University of Michigan Congenital Heart Center, Ann Arbor, MI (T.T.).
Tiffanie R JohnsonRiley Children's Hospital (Prairieland), Indianapolis, IN (T.R.J.).
Usha S KrishnanColumbia University Irving Medical Center, Morgan Stanley Children's Hospital of New York, NY (U.S.K.).ORCID 0000-0002-5733-6096
Stephen M ParidonChildren's Hospital of Philadelphia, University of Pennsylvania School of Medicine, Philadelphia, PA (D.J.G., S.M.P.).ORCID 0000-0003-3330-0598
Peter C FrommeltChildren's Hospital of Wisconsin, Medical College of Wisconsin, Milwaukee, WI (B.G., M.S., P.C.F.).
Pediatric Heart Network
Children's Hospital of Wisconsin · USCincinnati Children's Hospital Medical Center · USChildren's Hospital of Philadelphia · USTexas Children's Hospital · USUnited Electric Controls (United States) · USBoston Children's Hospital · USCedars-Sinai Smidt Heart Institute · USChildren's Healthcare of Atlanta · USChildren's Hospital Colorado · USChildren's Hospital & Medical Center · USChildren's Hospital of Los Angeles · USChildren's National · USC. S. Mott Children's Hospital · USDuke University · USDuPont (United States) · USHospital for Sick Children · CAMedical University of South Carolina · USMorgan Stanley Children's Hospital · USPhoenix Children's Hospital · USPrimary Children's Hospital · US

Funding

Pediatric Heart network DCCU10HL068270 · NHLBI · NEW ENGLAND RESEARCH INSTITUTES, INC. · PI MILLER, JULIE ELAINE, TRACHTENBERG, FELICIA LYNN · 2011 to 2016
$44.9M
Ventricular Volumes and Varability (VVV)U01HL068270 · NHLBI · NEW ENGLAND RESEARCH INSTITUTES, INC. · PI SLEEPER, LYNN A · 2001 to 2010
$40.3M
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
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
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 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
Pediatric Heart Network Emory UniversityUG1HL135682 · NHLBI · EMORY UNIVERSITY · PI BOOK, WENDY M., KOCHILAS, LAZAROS K. · 2017 to 2023
$2.2M
Pediatric Heart Network - The Hospital for Sick Children, TorontoUG1HL135680 · NHLBI · HOSPITAL FOR SICK CHLDRN (TORONTO) · PI MCCRINDLE, BRIAN W, MITAL, SEEMA · 2017 to 2023
$1.7M
NHLBI NIH HHS U01 HL068270NHLBI NIH HHS U10 HL068270NHLBI 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 HL135689
6 · The paper itself

Abstract

backgroundThe FUEL trial (Fontan Udenafil Exercise Longitudinal) demonstrated statistical improvements in exercise capacity following 6 months of treatment with udenafil (87.5 mg po BID). The effect of udenafil on echocardiographic measures of single ventricle function in this cohort has not been studied.

methodsThe 400 enrolled participants were randomized 1:1 to udenafil or placebo. Protocol echocardiograms were obtained at baseline and 26 weeks after initiation of udenafil/placebo. Linear regression compared change from baseline indices of single ventricle systolic, diastolic and global function, atrioventricular valve regurgitation, and mean Fontan fenestration gradient in the udenafil cohort versus placebo, controlling for ventricular morphology (left ventricle versus right ventricle/other) and baseline value.

resultsThe udenafil participants (n=191) had significantly improved between baseline and 26 weeks visits compared to placebo participants (n=195) in myocardial performance index (

conclusionsFUEL participants who received udenafil demonstrated a statistically significant improvement in some global and diastolic echo indices. Although small, the changes in diastolic function suggest improvement in pulmonary venous return and/or augmented ventricular compliance, which may help explain improved exercise performance in that cohort. REGISTRATION: URL: https://clinicaltrials.gov; Unique Identifier: NCT02741115.

Indexed as

EchocardiographySulfonamidesBenzenesulfonamidesDiastoleHumansPyrimidinesVentricular Function, LeftBenzenesulfonamidesPyrimidinesSulfonamidesudenafiladolescentsanaerobic thresholdcardiopulmonary exercise testFontan, echocardiographyphosphodiestherase-5-inhibitor

Identifiers

PMID36378780
PMCPMC9674374
OpenAlexW4309193297

What Socratic holds

Textmetadata
LicenceTDM
Read underepoch 390

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 Socratic graph.