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

BACKGROUND: We assessed the efficacy and safety of tadalafil, a phosphodiesterase type 5 inhibitor, in patients with heart failure with preserved ejection fraction and combined postcapillary and precapillary pulmonary hypertension. METHODS: In the double-blind PASSION study (Phosphodiesterase-5 Inhibition in Patients With Heart Failure With Preserved Ejection Fraction and Combined Post- and Pre-Capillary Pulmonary Hypertension), patients with heart failure with preserved ejection fraction and combined postcapillary and precapillary pulmonary hypertension were randomized 1:1 to receive tadalafil at a target dose of 40 mg or placebo. The primary end point was the time to the first composite event of adjudicated heart failure hospitalization or all-cause death. Secondary end points included all-cause mortality and improvements in New York Heart Association functional class or

• Hoeper, M. M.
• Oerke, B.
• Wissmüller, M.
• Leuchte, H.
• Opitz, C.
• Halank, M.
• Seyfarth, H. J.
• Baldus, S.
• Bauersachs, J.
• Böhm, M.
• Ghofrani, H. A.
• Konstantinides, S.
• Olsson, K. M.
• Wachter, R.
• Lam, C. S. P.
• Aminossadati, B.
• Rosenkranz, S.