In The Fontan Udenafil Exercise Longitudinal Trial (FUEL), udenafil treatment was not associated with an improvement in oxygen consumption at peak exercise in patients with Fontan physiology; however, multiple measures of exercise performance at the ventilatory anaerobic threshold did show marked improvements.
Dr David Goldberg (Children’s Hospital of Philadelphia, USA) presented the 30-centre phase 3 clinical trial that attempted to address a problem resulting from the Fontan physiology, which can lead to deterioration of cardiovascular efficiency associated with a decline in exercise performance . The researchers hypothesised that udenafil may improve exercise performance. The primacy efficacy endpoint of this study was a between-group difference in the change in oxygen consumption (VO2) from baseline to 26 weeks at peak exercise. Key secondary endpoints included myocardial performance index, exerc...
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