Heart failure & cardiomyopathies
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
An erratum to this article was published (Circulation, 18 Mar 2025 ↗)
- 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
Methodological detailsdouble-blind, placebo-controlled
- Double-blind
- Placebo-controlled
Primary result
As reported in the abstract
Hazard ratio
1.02
95% CI 0.52–2.01
P = 0.95
Events by treatment group
Secondary outcomes
| Outcome | HR (95% CI) | P value | |
|---|---|---|---|
| All-cause mortalityPossible 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
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