Heart failure & cardiomyopathiesRandomised controlled trial
Tadalafil for Treatment of Combined Postcapillary and Precapillary Pulmonary Hypertension in Patients With Heart Failure and Preserved Ejection Fraction: A Randomized Controlled Phase 3 Study
- Randomised controlled trial
- double-blind
- placebo-controlled
- terminated early
- Terminated early because of disruption in study medication supply
Authors' conclusion
The PASSION trial, terminated prematurely due to study medication supply disruption, does not support tadalafil use in patients with heart failure with preserved ejection fraction and combined postcapillary and precapillary pulmonary hypertension, with potential safety concerns and no observed benefits in primary and secondary end points.
Study context
- Population
- Patients with HFpEF and combined postcapillary and precapillary pulmonary hypertension372 targeted
- Participants
- 125 patients
- Comparison
- Tadalafil vs placebo
- Tadalafiln = 62
- Placebon = 63reference
- Primary endpoint
- Time to first composite of:
- Adjudicated HF hospitalization
- All-cause death
Primary result
As reported in the abstract
Hazard ratio
1.02
95% CI 0.52–2.01
P = 0.95
Events by treatment group
Tadalafil vs Placebo
HR 1.02 (95% CI 0.52–2.01); P = 0.95
Secondary outcomes
| Outcome | HR (95% CI) | P value | |
|---|---|---|---|
| All-cause mortality · possible signal of higher mortality with tadalafil | 5.10 (1.10–23.69) | P = 0.04 | |
| 0.050.21520Hazard ratio (log scale) |
Other secondary end points (NYHA class or ≥10% improvement in 6-minute walking distance)
- No significant between-group differences
Safety
Serious adverse events
Original publication
Tadalafil for Treatment of Combined Postcapillary and Precapillary Pulmonary Hypertension in Patients With Heart Failure and Preserved Ejection Fraction: A Randomized Controlled Phase 3 Study. Circulation. Published 28 June 2024. doi:10.1161/circulationaha.124.069340
Summarised from the published abstract; every number is checked against it