SERVE trial finds no effect of tadalafil in patients with systemic right ventricles
15.06.2023 – Final results of a double-blind, placebo-controlled, randomized trial in patients with a rare, congenital heart disease have now been published.
Adults with a congenital heart disease requiring an atrial switch operation for complete transposition of the great arteries (D-TGA), or with congenitally corrected transposition of the great arteries (ccTGA), often experience worsening of their right ventricular systolic function. This is associated with adverse outcomes. The aim of the SERVE trial was to assess whether daily intake of a phosphodiesterase-5-inhibitor (tadalafil) could improve the right ventricular systolic function over three years.
The SERVE study was funded within the Swiss National Science Foundation Investigator-Initiated Clinical Trials program. It was designed as a double-blind, randomized, placebo-controlled, multi-center trial and enrolled 100 adults with systemic right ventricles from Switzerland and Austria. Patients were randomized to receive either tadalafil 20mg once daily or placebo once daily. The primary endpoint was the change in right ventricular endsystolic volume after three years of therapy compared to pre-randomization.
Primary endpoint data was available for 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 both the tadalafil and the placebo-groups, and no significant differences in these changes were observed between the two treatment groups (mean difference of the change 3.4ml, 95% CI, -4.3 to 11.0, p=0.39). Further research is therefore needed to find effective treatments to improve the ventricular functioning of adults with systemic right ventricles.
CTU Bern was heavily involved from the planning until the publication of the trial and was responsible for the trial database (Data Management), the quality of the data (Central Data Monitoring and on-site Monitoring) and the full statistical analysis process (Statistics and Methodology).
Please find the publication here: https://onlinelibrary.wiley.com/doi/10.1002/ejhf.2924