Effect of phosphodiesterase-5 inhibition on SystEmic Right VEntricular size and function - a multi-center, double-blind, randomized, placebo-controlled trial - SERVE.

Greutmann, Matthias; Tobler, Daniel; Engel, Reto; Heg, Dik; Mueller, Christian; Frenk, André; Gabriel, Harald; Rutz, Tobias; Buechel, Ronny R; Willhelm, Matthias; Trachsel, Lukas; Freese, Michael; Ruperti-Repilado, Francisco Javier; Buechel, Emanuela Valsangiacomo; Beitzke, Dietrich; Haaf, Philip; Wustmann, Kerstin; Schwitz, Fabienne; Possner, Mathias; Schwitter, Juerg; ... (2023). Effect of phosphodiesterase-5 inhibition on SystEmic Right VEntricular size and function - a multi-center, double-blind, randomized, placebo-controlled trial - SERVE. European journal of heart failure, 25(7), pp. 1105-1114. Wiley 10.1002/ejhf.2924

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BACKGROUND AND AIMS

In adults with congenital heart disease and systemic right ventricles, progressive right ventricular systolic dysfunction is common and is associated with adverse outcomes. Our aim was to assess the impact of the phosphodiesterase-5-inhibitor tadalafil on right ventricular systolic function.

METHODS AND RESULTS

This was a double-blind, randomized, placebo-controlled, multi-center superiority trial (NCT03049540) involving 100 adults with systemic right ventricles (33 women, mean age: 40.7 years, SD 10.7), comparing tadalafil 20mg once daily versus placebo (1:1-ratio). Primary endpoint was the change in right ventricular endsystolic volume after three years of therapy. Secondary endpoints were changes in right ventricular ejection fraction, exercise capacity and NT-proBNP-concentration. Primary endpoint assessment by intention to treat analysis at three years of follow up was possible in 83 patients (42 patients in the tadalafil group and 41 patients in the placebo group). No significant changes over time in right ventricular endsystolic volumes were observed in the tadalafil and the placebo-group, and no significant differences between treatment groups (3.4ml, 95% CI, -4.3 to 11.0, p=0.39). No significant changes over time were observed for the pre-specified secondary endpoints for the entire study population, without differences between the tadalafil and the placebo-group.

CONLCUSIONS

In this trial in adults with systemic right ventricles, right ventricular systolic function, exercise capacity and neuro-hormonal activation remained stable over a three-year follow-up period. No significant treatment effect of tadalafil was observed. Further research is needed to find effective treatment for improvement of ventricular function in adults with systemic right ventricles. This article is protected by copyright. All rights reserved.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Cardiology
04 Faculty of Medicine > Pre-clinic Human Medicine > Department of Clinical Research (DCR)

UniBE Contributor:

Heg, Dierik Hans, Frenk, André, Trachsel, Lukas Daniel, Schwitz, Fabienne Muriel, Schwerzmann, Markus

Subjects:

600 Technology > 610 Medicine & health

ISSN:

1879-0844

Publisher:

Wiley

Funders:

[4] Swiss National Science Foundation

Language:

English

Submitter:

Pubmed Import

Date Deposited:

05 Jun 2023 12:07

Last Modified:

03 Jun 2024 00:25

Publisher DOI:

10.1002/ejhf.2924

PubMed ID:

37264734

Additional Information:

Open access funding provided by Universität Zürich.

Uncontrolled Keywords:

atrial switch operation congenitally corrected transposition of the great arteries d-transposition of the great arteries phosphodiesterase-5-inhibitor systemic right ventricle

BORIS DOI:

10.48350/183136

URI:

https://boris.unibe.ch/id/eprint/183136

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