Congenital heart diseaseRandomised controlled trial
Results of the FUEL Trial
- Randomised controlled trial
- phase III
- placebo-controlled
- 30 centres
Authors' conclusion
In the FUEL trial, treatment with udenafil (87.5 mg twice daily) was not associated with an improvement in oxygen consumption at peak exercise but was associated with improvements in multiple measures of exercise performance at the ventilatory anaerobic threshold.
Study context
- Population
- Participants with Fontan physiology, North America and Republic of Korea, 2017–2019all 400 in primary analysis
- Participants
- 400 participants
- Comparison
- Udenafil vs placebo
- Primary endpoint
- Between-group difference in change in oxygen consumption at peak exercise
- Follow-up
- 26 weeks
Primary result
As reported in the abstract
Change in peak oxygen consumption
| Group | Value | percent change |
|---|---|---|
| Udenafil | mean change 44 (SD 245) mL/min | 2.8% |
| Placebo | mean decline 3.7 (SD 228) mL/min | −0.2% |
- Udenafil vs Placebo: P = 0.071
Secondary outcomes
| Outcome | Udenafil | Placebo | P value |
|---|---|---|---|
| Oxygen consumption at ventilatory anaerobic threshold | mean change +33 (SD 185) mL/min | mean change −9 (SD 193) mL/min | P = 0.012 |
| percent change | 3.2% | −0.9% | |
| Ventilatory equivalents of CO2 at ventilatory anaerobic threshold | −0.8 | −0.06 | P = 0.014 |
| Work rate at ventilatory anaerobic threshold | +3.8 W | +0.34 W | P = 0.021 |
Myocardial performance index, ln reactive hyperemia index, serum BNP
- No difference in change
Original publication
Results of the FUEL Trial. Circulation. Published 17 November 2019. doi:10.1161/circulationaha.119.044352
Summarised from the published abstract; every number is checked against it