PASSION


Study information
PASSION

Recruiting status

Recruiting stopped

Recruitment start

10/2018

Patients

123

356

Clinical Trials Registration

2017-003688-37

Category

Guideline relevant study

DZHK Funding

DZHK-assoziierte Studie (keine finanzielle Förderung)

Operative contact
Main study center
Kerstin Winterstein
kerstin.balthasar@kks.uni-marburg.de

Phosphodiesterase-5 inhibition in patients with combined pre- and postcapillary pulmonary hypertension due to heart failure with preserved ejection fraction (PASSION)

Update: In June 2022, the manufacturer "neuraxpharm" withdrew the verum test medication ("Tadalafil tablets") used in the double-blind PASSION study. This resulted in an immediate termination of the study therapy for all trial participants (irrespective of whether they were taking placebo or verum). It was no longer possible to ensure an adequate supply of the trial medication to the participants. The final documentation of the final examinations should be completed by the end of 01/2023 by the trial sites.

The DZHK associated trial PASSION investigates whether the drug Tadalafil can reduce cardiac-related hospital admissions and mortality of patients with combined pre- and post-capillary pulmonary hypertension due to heart failure. The randomised, placebo-controlled, double-blind study under the direction of Prof. Dr. Marius Hoeper, Hanover, and Prof. Dr. Stephan Rosenkranz, Cologne, involves 356 patients.

Patients in the intervention group will initially receive Tadalafil in a dose of 20 mg qd, which will be increased to the target dose of 40 mg qd after 4 weeks. The control group receives a placebo and is treated with the standard therapy. PASSION is funded by the German Federal Ministry of Education and Research (BMBF) and is being conducted in cooperation with the German Center for Lung Research (DZL).

Publications

There are no publications available yet.

Principal Investigators

Marius Hoeper (Hannover), Stephan Rosenkranz (Köln)