PASSION
Trial question
What is the role of tadalafil in patients with HFpEF and combined postcapillary and precapillary pulmonary hypertension?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
73.0% female
27.0% male
N = 125
125 patients (91 female, 34 male).
Inclusion criteria: patients with HFpEF and combined postcapillary and precapillary pulmonary hypertension.
Key exclusion criteria: age < 18 years; pregnancy or lactation.
Interventions
N=62 tadalafil (target dose of 40 mg once daily).
N=63 placebo (matching placebo).
Primary outcome
Time to first heart failure hospitalization or death
27%
32%
32.0 %
24.0 %
16.0 %
8.0 %
0.0 %
Tadalafil
Placebo
No significant
difference ↔
No significant difference in time to first HF hospitalization or death (27% vs. 32%; HR 1.02, 95% CI 0.52 to 2.01).
Secondary outcomes
No significant difference in time to clinical worsening (27% vs. 38%; HR 0.75, 95% CI 0.4 to 1.39).
Significantly greater improvement in mean 6MWD (5.2 m vs. 16.3 m; MD 11.1, 95% CI 12.6 to 34.8).
Safety outcomes
No significant difference in serious adverse events.
Conclusion
In patients with HFpEF and combined postcapillary and precapillary pulmonary hypertension, tadalafil was not superior to placebo with respect to time to first HF hospitalization or death.
Reference
Marius M Hoeper, Britta Oerke, Max Wissmüller et al. 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. 2024 Aug 20;150(8):600-610.
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