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

Autor:	Di Maria MV; Children's Hospital Colorado, University of Colorado School of Medicine, Aurora, CO (M.V.D.M.)., Goldberg DJ; Children's Hospital of Philadelphia, University of Pennsylvania School of Medicine, Philadelphia, PA (D.J.G., S.M.P.)., Zak V; Healthcore, Watertown, MA (V.Z., C.H.)., Hu C; Healthcore, Watertown, MA (V.Z., C.H.)., 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.)., Dragulescu A; Hospital for Sick Children, Toronto, Ontario, Canada (A.D.)., Mackie AS; Stollery Children's Hospital, University of Alberta, Edmonton, Canada (A.S.M.)., McCrary A; Duke University, Durham, NC (A.M.C.)., Weingarten A; Vanderbilt Heart and Vascular Institute, Nashville, TN (A.W.)., Parthiban A; Texas Children's Hospital, Baylor College of Medicine, Houston, TX (A.P., P.E.)., Goot B; Children's Hospital of Wisconsin, Medical College of Wisconsin, Milwaukee, WI (B.G., M.S., P.C.F.)., 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.)., Taylor C; Shawn Jenkins Children's Hospital, Medical University of South Carolina, Charleston, SC (C.T.)., Lindblade C; Phoenix Children's Hospital, University of Arizona, Phoenix, AZ (C.L.)., Petit CJ; Children's Heart Center, Emory University School of Medicine, Atlanta, GA (C.J.P.)., Spurney C; Children's National Hospital, Washington, DC (C.S.)., Harrild DM; Boston Children's Hospital, MA (D.M.H.)., 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.)., Schuchardt E; Rady Children's Hospital, University of California San Diego, CA (E.S.)., Beom Kim G; Seoul National University Children's Hospital, Seoul National University College of Medicine, South Korea (G.B.K.)., Kyoung Yoon J; Sejong Hospital Cardiovascular Center, Department of Pediatrics, Bucheon, South Korea (J.K.Y.)., Colombo JN; St. Louis Children's Hospital, Washington University School of Medicine, St Louis, MO (J.N.C.)., Files MD; Seattle Children's Hospital, University of Washington, Seattle, WA (M.D.F.)., Schoessling M; Children's Hospital of Wisconsin, Medical College of Wisconsin, Milwaukee, WI (B.G., M.S., P.C.F.)., Ermis P; Texas Children's Hospital, Baylor College of Medicine, Houston, TX (A.P., P.E.)., Wong PC; Children's Hospital of Los Angeles, Keck School of Medicine of USC, Los Angeles, CA (P.C.W.)., Garg R; Smidt Heart Institute, Cedars-Sinai, Los Angeles, CA (R.G.)., Swanson SK; Children's Hospital and Medical Center, Omaha, NE (S.K.S.)., Menon SC; Primary Children's Hospital, University of Utah, Salt Lake City, UT (S.C.M.)., Srivastava S; Nemours, AI DuPont, Wilmington, DE (S.S.)., Thorsson T; C.S. Mott Children's Hospital, University of Michigan Congenital Heart Center, Ann Arbor, MI (T.T.)., Johnson TR; Riley Children's Hospital (Prairieland), Indianapolis, IN (T.R.J.)., Krishnan US; Columbia University Irving Medical Center, Morgan Stanley Children's Hospital of New York, NY (U.S.K.)., Paridon SM; Children's Hospital of Philadelphia, University of Pennsylvania School of Medicine, Philadelphia, PA (D.J.G., S.M.P.)., Frommelt PC; Children's Hospital of Wisconsin, Medical College of Wisconsin, Milwaukee, WI (B.G., M.S., P.C.F.).
Jazyk:	angličtina
Zdroj:	Circulation. Cardiovascular imaging [Circ Cardiovasc Imaging] 2022 Nov; Vol. 15 (11), pp. e013676. Date of Electronic Publication: 2022 Nov 15.
DOI:	10.1161/CIRCIMAGING.121.013676
Abstrakt:	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 ( P =0.03, adjusted mean difference [SE] of changes between groups -0.03[0.01]), atrioventricular valve inflow peak E ( P =0.009, 3.95 [1.50]), and A velocities ( P =0.034, 3.46 [1.62]), and annular Doppler tissue imaging-derived peak e' velocity ( P =0.008, 0.60[0.23]). There were no significant differences in change in single ventricle size, systolic function, atrioventricular valve regurgitation severity, or mean fenestration gradient. Participants with a dominant left ventricle had significantly more favorable baseline values of indices of single ventricle size and function (lower volumes and areas, E/e' ratio, systolic:diastolic time and atrioventricular valve regurgitation, and higher annular s' and e' velocity). 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.
Databáze:	MEDLINE
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