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Effect of phosphodiesterase-5 inhibition on SystEmic Right VEntricular size and function - A multicentre, double-blind, randomized, placebo-controlled trial - SERVE

Authors :
Greutmann, Matthias; https://orcid.org/0000-0002-8692-6108
Tobler, Daniel; https://orcid.org/0000-0002-0821-3196
Engel, Reto
Heg, Dik
Mueller, Christian; https://orcid.org/0000-0002-1120-6405
Frenk, André
Gabriel, Harald
Rutz, Tobias
Buechel, Ronny R; https://orcid.org/0000-0001-8064-8904
Willhelm, Matthias
Trachsel, Lukas
Freese, Michael
Ruperti-Repilado, Francisco Javier; https://orcid.org/0000-0002-9904-0402
Valsangiacomo Buechel, Emanuela
Beitzke, Dietrich; https://orcid.org/0000-0003-3179-3827
Haaf, Philip; https://orcid.org/0000-0002-5657-6637
Wustmann, Kerstin
Schwitz, Fabienne
Possner, Mathias
Schwitter, Juerg
Bouchardy, Judith
Schwerzmann, Markus; https://orcid.org/0000-0002-4006-8929
SERVE Investigators
Greutmann, Matthias; https://orcid.org/0000-0002-8692-6108
Tobler, Daniel; https://orcid.org/0000-0002-0821-3196
Engel, Reto
Heg, Dik
Mueller, Christian; https://orcid.org/0000-0002-1120-6405
Frenk, André
Gabriel, Harald
Rutz, Tobias
Buechel, Ronny R; https://orcid.org/0000-0001-8064-8904
Willhelm, Matthias
Trachsel, Lukas
Freese, Michael
Ruperti-Repilado, Francisco Javier; https://orcid.org/0000-0002-9904-0402
Valsangiacomo Buechel, Emanuela
Beitzke, Dietrich; https://orcid.org/0000-0003-3179-3827
Haaf, Philip; https://orcid.org/0000-0002-5657-6637
Wustmann, Kerstin
Schwitz, Fabienne
Possner, Mathias
Schwitter, Juerg
Bouchardy, Judith
Schwerzmann, Markus; https://orcid.org/0000-0002-4006-8929
SERVE Investigators
Source :
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; Valsangiacomo Buechel, Emanuela; Beitzke, Dietrich; Haaf, Philip; Wustmann, Kerstin; Schwitz, Fabienne; Possner, Mathias; Schwitter, Juerg; Bouchardy, Judith; Schwerzmann, Markus; SERVE Investigators (2023). Effect of phosphodiesterase-5 inhibition on SystEmic Right VEntricular size and function - A multicentre, double-blind, randomized, placebo-controlled trial - SERVE. European Journal of Heart Failure, 25(7):1105-1114.
Publication Year :
2023

Abstract

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, multicentre superiority trial (NCT03049540) involving 100 adults with systemic right ventricles (33 women, mean age: 40.7 ± 10.7 years), comparing tadalafil 20 mg once daily versus placebo (1:1 ratio). The primary endpoint was the change in right ventricular end-systolic volume after 3 years of therapy. Secondary endpoints were changes in right ventricular ejection fraction, exercise capacity and N-terminal pro-B-type natriuretic peptide concentration. Primary endpoint assessment by intention to treat analysis at 3 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 end-systolic volumes were observed in the tadalafil and the placebo group, and no significant differences between treatment groups (3.4 ml, 95% confidence interval -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. CONCLUSIONS In this trial in adults with systemic right ventricles, right ventricular systolic function, exercise capacity and neuro-hormonal activation remained stable over a 3-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.

Details

Database :
OAIster
Journal :
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; Valsangiacomo Buechel, Emanuela; Beitzke, Dietrich; Haaf, Philip; Wustmann, Kerstin; Schwitz, Fabienne; Possner, Mathias; Schwitter, Juerg; Bouchardy, Judith; Schwerzmann, Markus; SERVE Investigators (2023). Effect of phosphodiesterase-5 inhibition on SystEmic Right VEntricular size and function - A multicentre, double-blind, randomized, placebo-controlled trial - SERVE. European Journal of Heart Failure, 25(7):1105-1114.
Notes :
application/pdf, info:doi/10.5167/uzh-234638, English, English
Publication Type :
Electronic Resource
Accession number :
edsoai.on1443052547
Document Type :
Electronic Resource