Effect of phosphodiesterase-5 inhibition on SystEmic Right VEntricular size and function. A multicentre, double-blind, randomized, placebo-controlled trial: SERVE.
Atrial switch operation
Congenitally corrected transposition of the great arteries
Phosphodiesterase-5 inhibitor
Systemic right ventricle
d-Transposition of the great arteries
Journal
European journal of heart failure
ISSN: 1879-0844
Titre abrégé: Eur J Heart Fail
Pays: England
ID NLM: 100887595
Informations de publication
Date de publication:
07 2023
07 2023
Historique:
revised:
11
04
2023
received:
28
01
2023
accepted:
24
05
2023
medline:
9
8
2023
pubmed:
2
6
2023
entrez:
2
6
2023
Statut:
ppublish
Résumé
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. 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. 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.
Substances chimiques
Tadalafil
742SXX0ICT
Cyclic Nucleotide Phosphodiesterases, Type 5
EC 3.1.4.35
Banques de données
ClinicalTrials.gov
['NCT03049540']
Types de publication
Randomized Controlled Trial
Multicenter Study
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1105-1114Investigateurs
David Herzig
(D)
Prisca Eser
(P)
Coralie Blanche
(C)
Dominik Stambach
(D)
Niklas Ehl
(N)
Irene M Lang
(IM)
Julia Mascherbauer
(J)
Matthias Schneider
(M)
Rochus Pokan
(R)
Christine H Attenhofer Jost
(CH)
Bruno Santos Lopes
(BS)
Francesca Bonassin Tempesta
(FB)
Lukas Meier
(L)
Daniela Babic
(D)
Georgios Benetos
(G)
David Jean Winkel
(DJ)
Informations de copyright
© 2023 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.
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