Congenital heart diseaseRandomised controlled trial
Effect of Phosphodiesterase-5 Inhibition on Systemic Right Ventricular Size and Function. A Multicentre, Double-Blind, Randomized, Placebo-Controlled Trial: SERVE
- Randomised controlled trial
- double-blind
- placebo-controlled
- multicentre
- superiority
Authors' conclusion
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.
Study context
- Population
- Adults with congenital heart disease and systemic RVs83 analysed at 3 years
- Participants
- 100 adults
- Comparison
- Tadalafil vs placebo
- Primary endpoint
- Change in RV end-systolic volume
- Follow-up
- 3 years
Primary result
As reported in the abstract
Difference
3.4 ml
95% CI −4.3 to 11.0
P = 0.39
Tadalafil vs Placebo
difference 3.4 ml (95% CI −4.3 to 11.0); P = 0.39
Secondary outcomes
RV ejection fraction, exercise capacity, NT-proBNP
- No significant changes over time; no differences between tadalafil and placebo
Original publication
Effect of Phosphodiesterase-5 Inhibition on Systemic Right Ventricular Size and Function. A Multicentre, Double-Blind, Randomized, Placebo-Controlled Trial: SERVE. Eur J Heart Fail. Published 13 June 2023. doi:10.1002/ejhf.2924
Summarised from the published abstract; every number is checked against it