{"id":"44530ab64959","type":"article","url":"https://hartvaat.nl/2024/08/20/tadalafil-bij-gecombineerde-post-en-precapillaire-ph-en-hfpef/","title":"Tadalafil bij gecombineerde post- en precapillaire PH en HFpEF","title_en":"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.","category":"hartfalen","category_label":"Hartfalen","professions":["cardioloog"],"tags":["step-hfpef"],"journal":"Circulation","doi":"10.1161/CIRCULATIONAHA.124.069340","source_url":"https://doi.org/10.1161/CIRCULATIONAHA.124.069340","authors":["Marius M Hoeper","Britta Oerke","Max Wissmüller","Hanno Leuchte","Christian Opitz","Michael Halank","Hans-Juergen Seyfarth","Stephan Baldus","Johann Bauersachs","Michael Böhm","Hossein-Ardeschir Ghofrani","Stavros Konstantinides","Karen M Olsson","Rolf Wachter","Carolyn S P Lam","Behnaz Aminossadati","Stephan Rosenkranz"],"significance":6,"published":"2024-08-20","source_date":"2024-08-20","image":"","kennis":[],"congress":"","summary_en":"This study evaluated tadalafil for combined pre- and post-capillary pulmonary hypertension in HFpEF, showing modest hemodynamic improvement but failing to demonstrate robust clinical benefit for phosphodiesterase-5 inhibition in this phenotype.","created":"2026-07-03T10:31:06Z","updated":"2026-07-03T13:30:08Z","licence":"Citeer vrij, met bronvermelding en een link naar hartvaat.nl (de url van het record). Samenvattingen zijn redactioneel werk van HartVaat; de oorspronkelijke publicaties blijven van hun uitgevers (doi). Geen medisch advies.","body_markdown":"Studie onderzocht tadalafil bij gecombineerde PH (CpcPH) en HFpEF. Het middel verbeterde de pulmonale hemodynamiek bescheiden maar het klinische voordeel was beperkt. PDE5-remming bij HFpEF-PH blijft onbewezen.","abstract_original":"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 ≥10% improvement in 6-minute walking distance from baseline. RESULTS: Initially targeting 372 patients, the study was terminated early because of disruption in study medication supply. At that point, 125 patients had been randomized (placebo: 63; tadalafil: 62,). Combined primary end-point events occurred in 20 patients (32%) assigned to placebo and 17 patients (27%) assigned to tadalafil (hazard ratio, 1.02 [95% CI, 0.52-2.01]; P=0.95). There was a possible signal of higher all-cause mortality in the tadalafil group (hazard ratio, 5.10 [95% CI, 1.10-23.69]; P=0.04). No significant between-group differences were observed in other secondary end points. Serious adverse events occurred in 29 participants (48%) in the tadalafil group and 35 (56%) in the placebo group. CONCLUSIONS: 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. REGISTRATION: URL: https://www.clinicaltrialsregister.eu/; Unique identifier: 2017-003688-37. URL: https://drks.de; Unique identifier: DRKS -DRKS00014595."}