Impact of Udenafil on Echocardiographic Indices of Single Ventricle Size and Function in FUEL Study Participants-Reference-Cited by-同舟云学术

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

Published:2022-11 Issue:11 Volume:15 Page:
ISSN:1941-9651
Container-title:Circulation: Cardiovascular Imaging
language:en
Short-container-title:Circ: Cardiovascular Imaging

Author:

Di Maria Michael V.¹^ORCID,Goldberg David J.²,Zak Victor³,Hu Chenwei³,Lubert Adam M.⁴^ORCID,Dragulescu Andreea⁵,Mackie Andrew S.⁶,McCrary Andrew⁷,Weingarten Angela⁸^ORCID,Parthiban Anitha⁹,Goot Benjamin¹⁰,Goldstein Bryan H.⁴¹¹^ORCID,Taylor Carolyn¹²,Lindblade Christopher¹³^ORCID,Petit Christopher J.¹⁴^ORCID,Spurney Christopher¹⁵,Harrild David M.¹⁶,Urbina Elaine M.⁴^ORCID,Schuchardt Eleanor¹⁷^ORCID,Beom Kim Gi¹⁸,Kyoung Yoon Ja¹⁹^ORCID,Colombo Jamie N.²⁰,Files Matthew D.²¹,Schoessling Megan¹⁰,Ermis Peter⁹,Wong Pierre C.²²^ORCID,Garg Ruchira²³,Swanson Sara K.²⁴,Menon Shaji C.²⁵,Srivastava Shubhika²⁶,Thorsson Thor²⁷,Johnson Tiffanie R.²⁸,Krishnan Usha S.²⁹^ORCID,Paridon Stephen M.²^ORCID,Frommelt Peter C.¹⁰,

Affiliation:

1. Children’s Hospital Colorado, University of Colorado School of Medicine, Aurora, CO (M.V.D.M.).

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

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

4. Cincinnati Children’s Hospital, Heart Institute, Department of Pediatrics, University of Cincinnati College of Medicine, OH (A.M., B.H.G., E.M.U.).

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

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

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

8. Vanderbilt Heart and Vascular Institute, Nashville, TN (A.W.).

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

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

11. UPMC Children’s Hospital of Pittsburgh, University of Pittsburgh, PA (B.H.G.).

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

13. Phoenix Children’s Hospital, University of Arizona, Phoenix, AZ (C.L.).

14. Children’s Heart Center, Emory University School of Medicine, Atlanta, GA (C.J.P.).

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

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

17. Rady Children’s Hospital, University of California San Diego, CA (E.S.).

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

19. Sejong Hospital Cardiovascular Center, Department of Pediatrics, Bucheon, South Korea (J.K.Y.).

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

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

22. Children’s Hospital of Los Angeles, Keck School of Medicine of USC, Los Angeles, CA (P.C.W.).

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

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

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

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

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

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

29. Columbia University Irving Medical Center, Morgan Stanley Children’s Hospital of New York, NY (U.S.K.).

Abstract

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.

Publisher

Ovid Technologies (Wolters Kluwer Health)

Subject

Cardiology and Cardiovascular Medicine,Radiology, Nuclear Medicine and imaging

Reference46 articles.

1. Surgical repair of tricuspid atresia

2. The Fontan circulation after 45 years: update in physiology

3. Failure of the Fontan Circulation

4. Hemodynamics of Fontan Failure

5. The Fontan circulation: who controls cardiac output?

Cited by 2 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Advancements in Phosphodiesterase 5 Inhibitors: Unveiling Present and Future Perspectives;Pharmaceuticals;2023-09-06

2. Comparison of serum N-terminal pro-brain natriuretic peptide levels, conventional echocardiography, exercise parameters, and dyssynchrony measurements in Fontan patients;Cardiology in the Young;2023-09