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

Humans Echocardiography Sulfonamides / therapeutic use Pyrimidines / therapeutic use Diastole Ventricular Function, Left
Fontan, echocardiography adolescents anaerobic threshold cardiopulmonary exercise test phosphodiestherase-5-inhibitor

Journal

Circulation. Cardiovascular imaging
ISSN: 1942-0080
Titre abrégé: Circ Cardiovasc Imaging
Pays: United States
ID NLM: 101479935

Informations de publication

Date de publication:
11 2022
Historique:
entrez: 15 11 2022
pubmed: 16 11 2022
medline: 19 11 2022
Statut: ppublish

Résumé

The 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. The 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. The udenafil participants (n=191) had significantly improved between baseline and 26 weeks visits compared to placebo participants (n=195) in myocardial performance index ( FUEL 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. URL: https://clinicaltrials.gov; Unique Identifier: NCT02741115.

Sections du résumé

BACKGROUND
The 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.
METHODS
The 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.
RESULTS
The udenafil participants (n=191) had significantly improved between baseline and 26 weeks visits compared to placebo participants (n=195) in myocardial performance index (
CONCLUSIONS
FUEL 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.

Identifiants

DOI: 10.1161/CIRCIMAGING.121.013676 PMID: 36378780 PMC: PMC9674374
pubmed: 36378780
doi: 10.1161/CIRCIMAGING.121.013676
pmc: PMC9674374
mid: NIHMS1842105
doi:

Substances chimiques

udenafil L5IB4XLY36
Sulfonamides 0
Pyrimidines 0

Banques de données

ClinicalTrials.gov
['NCT02741115']

Types de publication

Randomized Controlled Trial Journal Article Research Support, N.I.H., Extramural

Langues

eng

Sous-ensembles de citation

IM

Pagination

e013676

Subventions

Organisme : NHLBI NIH HHS
ID : UG1 HL135665
Pays : United States
Organisme : NHLBI NIH HHS
ID : UG1 HL135666
Pays : United States
Organisme : NHLBI NIH HHS
ID : UG1 HL135680
Pays : United States
Organisme : NHLBI NIH HHS
ID : UG1 HL135646
Pays : United States
Organisme : NHLBI NIH HHS
ID : UG1 HL135683
Pays : United States
Organisme : NHLBI NIH HHS
ID : UG1 HL135685
Pays : United States
Organisme : NHLBI NIH HHS
ID : UG1 HL135689
Pays : United States
Organisme : NHLBI NIH HHS
ID : U10 HL068270
Pays : United States
Organisme : NHLBI NIH HHS
ID : U01 HL068270
Pays : United States
Organisme : NHLBI NIH HHS
ID : UG1 HL135678
Pays : United States
Organisme : NHLBI NIH HHS
ID : U24 HL135691
Pays : United States
Organisme : NHLBI NIH HHS
ID : UG1 HL135682
Pays : United States

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Auteurs

Michael V Di Maria (MV)

Children's Hospital Colorado, University of Colorado School of Medicine, Aurora, CO (M.V.D.M.).
ORCID: 0000-0003-0346-8517

David J Goldberg (DJ)

Children's Hospital of Philadelphia, University of Pennsylvania School of Medicine, Philadelphia, PA (D.J.G., S.M.P.).

Victor Zak (V)

Healthcore, Watertown, MA (V.Z., C.H.).

Chenwei Hu (C)

Healthcore, Watertown, MA (V.Z., C.H.).

Adam M Lubert (AM)

Cincinnati 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 Dragulescu (A)

Hospital for Sick Children, Toronto, Ontario, Canada (A.D.).

Andrew S Mackie (AS)

Stollery Children's Hospital, University of Alberta, Edmonton, Canada (A.S.M.).

Andrew McCrary (A)

Duke University, Durham, NC (A.M.C.).

Angela Weingarten (A)

Vanderbilt Heart and Vascular Institute, Nashville, TN (A.W.).
ORCID: 0000-0001-5712-6470

Anitha Parthiban (A)

Texas Children's Hospital, Baylor College of Medicine, Houston, TX (A.P., P.E.).

Benjamin Goot (B)

Children's Hospital of Wisconsin, Medical College of Wisconsin, Milwaukee, WI (B.G., M.S., P.C.F.).

Bryan H Goldstein (BH)

Cincinnati Children's Hospital, Heart Institute, Department of Pediatrics, University of Cincinnati College of Medicine, OH (A.M., B.H.G., E.M.U.).
UPMC Children's Hospital of Pittsburgh, University of Pittsburgh, PA (B.H.G.).
ORCID: 0000-0001-8508-9523

Carolyn Taylor (C)

Shawn Jenkins Children's Hospital, Medical University of South Carolina, Charleston, SC (C.T.).

Christopher Lindblade (C)

Phoenix Children's Hospital, University of Arizona, Phoenix, AZ (C.L.).
ORCID: 0000-0001-9173-2458

Christopher J Petit (CJ)

Children's Heart Center, Emory University School of Medicine, Atlanta, GA (C.J.P.).
ORCID: 0000-0002-9939-3048

Christopher Spurney (C)

Children's National Hospital, Washington, DC (C.S.).

David M Harrild (DM)

Boston Children's Hospital, MA (D.M.H.).

Elaine M Urbina (EM)

Cincinnati 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 Schuchardt (E)

Rady Children's Hospital, University of California San Diego, CA (E.S.).
ORCID: 0000-0002-9106-8486

Gi Beom Kim (G)

Seoul National University Children's Hospital, Seoul National University College of Medicine, South Korea (G.B.K.).

Ja Kyoung Yoon (J)

Sejong Hospital Cardiovascular Center, Department of Pediatrics, Bucheon, South Korea (J.K.Y.).
ORCID: 0000-0002-6104-5259

Jamie N Colombo (JN)

St. Louis Children's Hospital, Washington University School of Medicine, St Louis, MO (J.N.C.).

Matthew D Files (MD)

Seattle Children's Hospital, University of Washington, Seattle, WA (M.D.F.).

Megan Schoessling (M)

Children's Hospital of Wisconsin, Medical College of Wisconsin, Milwaukee, WI (B.G., M.S., P.C.F.).

Peter Ermis (P)

Texas Children's Hospital, Baylor College of Medicine, Houston, TX (A.P., P.E.).

Pierre C Wong (PC)

Children's Hospital of Los Angeles, Keck School of Medicine of USC, Los Angeles, CA (P.C.W.).
ORCID: 0000-0003-3794-5887

Ruchira Garg (R)

Smidt Heart Institute, Cedars-Sinai, Los Angeles, CA (R.G.).

Sara K Swanson (SK)

Children's Hospital and Medical Center, Omaha, NE (S.K.S.).

Shaji C Menon (SC)

Primary Children's Hospital, University of Utah, Salt Lake City, UT (S.C.M.).

Shubhika Srivastava (S)

Nemours, AI DuPont, Wilmington, DE (S.S.).

Thor Thorsson (T)

C.S. Mott Children's Hospital, University of Michigan Congenital Heart Center, Ann Arbor, MI (T.T.).

Tiffanie R Johnson (TR)

Riley Children's Hospital (Prairieland), Indianapolis, IN (T.R.J.).

Usha S Krishnan (US)

Columbia University Irving Medical Center, Morgan Stanley Children's Hospital of New York, NY (U.S.K.).
ORCID: 0000-0002-5733-6096

Stephen M Paridon (SM)

Children'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 Frommelt (PC)

Children's Hospital of Wisconsin, Medical College of Wisconsin, Milwaukee, WI (B.G., M.S., P.C.F.).

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Classifications MeSH

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questionsmedicales.fr › Diagnostic › Techniques et procédures diagnostiques › Techniques de diagnostic cardiovasculaire › Tests de la fonction cardiaque › Échocardiographie › Impact of Udenafil on Echocardiographic...
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