Details

Autor(en) / Beteiligte

• 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
• Herzig, David
• Eser, Prisca
• Blanche, Coralie
• Stambach, Dominik
• Ehl, Niklas
• Lang, Irene M.
• Mascherbauer, Julia
• Schneider, Matthias
• Pokan, Rochus
• Attenhofer Jost, Christine H.
• Lopes, Bruno Santos
• Tempesta, Francesca Bonassin
• Meier, Lukas
• Babic, Daniela
• Benetos, Georgios
• Winkel, David Jean

Titel

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

Ist Teil von

• European journal of heart failure, 2023-07, Vol.25 (7), p.1105-1114

Ort / Verlag

Oxford, UK: John Wiley & Sons, Ltd

Erscheinungsjahr

2023

Quelle

Wiley Online Library Journals Frontfile Complete

Beschreibungen/Notizen

• 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. Promising effects of phosphodiesterase‐5 inhibition on function of hypertrophied right ventricles in experimental and animal models did not translate into a clinical benefit in this randomized, placebo‐controlled trial in adults with congenital heart disease and systemic right ventricles. Tadalafil had no impact on right ventricular function, exercise capacity or neuro‐hormonal activation. Further prospective studies on the effectiveness of novel treatment options for these patients are urgently needed. RV, right ventricle; RVEF, right ventricular ejection fraction; VO2, oxygen uptake.