The PennZone

SEOUL, South Korea, Aug. 12, 2025 ~ A recent study published in the Journal of the American Heart Association has revealed promising results for adolescents with single ventricle congenital heart disease (SV-CHD) who have undergone the Fontan procedure. The post-hoc analysis of the FUEL Trial, a landmark study on udenafil, a PDE5 inhibitor, showed that it significantly improves peak oxygen consumption (peak VO₂) in this patient population.

The original FUEL trial, which was a multinational, randomized, placebo-controlled Phase 3 trial, had already demonstrated significant improvements in secondary endpoints such as VO₂ at ventilatory anaerobic threshold (VAT) and myocardial performance index (MPI). However, it narrowly missed statistical significance for the primary endpoint of peak VO₂ in the overall population.

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Upon further analysis, researchers discovered a subgroup of participants with high exercise capacity known as "Super Fontans." This prompted them to stratify the data based on baseline peak VO₂ levels. The results showed that udenafil had a significant impact on improving peak VO₂ in this subgroup.

These findings provide hope for adolescents with SV-CHD who have undergone the Fontan procedure and struggle with reduced exercise capacity. Further research is needed to fully understand the potential benefits of udenafil in this patient population.

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