Publication Date

11-1-2022

Journal

Circulation: Cardiovascular Imaging

DOI

10.1161/CIRCIMAGING.121.013676

PMID

36378780

PMCID

PMC9674374

PubMedCentral® Posted Date

11-15-2023

PubMedCentral® Full Text Version

Author MSS

Published Open-Access

yes

Keywords

Humans, Echocardiography, Sulfonamides, Pyrimidines, Diastole, Ventricular Function, Left, Fontan, echocardiography, cardiopulmonary exercise test, phosphodiestherase-5-inhibitor, Congenital Heart Disease, Echocardiography, Exercise

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 (

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.

Clinical Trial Registration Information: ClinicalTrials.gov Identifier: NCT02741115; https://clinicaltrials.gov/ct2/show/NCT02741115

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