CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 100 enrolled
Drug / intervention
Tadalafil 20 MG +1 moredrug
Likely dose
Tadalafil 20 MGfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03049540
NCT03049540Phase 3Completed

Effect of Phosphodiesterase-5 Inhibition With Tadalafil on SystEmic Right VEntricular Size and Function - a Multi-center, Double-blind, Randomized, Placebo-controlled Clinical Trial - SERVE Trial

Insel Gruppe AG, University Hospital Bern·interventional·Posted Feb 10, 2017·Updated Jun 23, 2023

In Brief

A Phase 3 clinical trial evaluating Tadalafil 20 MG and Placebo 20 MG for Heart Defects, Congenital and Transposition of Great Vessels With Ventricular Inversion. Completed, enrolled 100 participants across 7 sites in 2 countries.

Detailed Summary

This study assesses in a double-blind, randomized, placebo-controlled multi-center pilot trial the effect of PDE-5 inhibition with Tadalafil on right ventricle size and function, exercise capacity and neurohumoral activation in adults with congenital heart disease and a right ventricle in subaortic position over a 3-year follow-up period.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustria, Switzerland

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 10, 2017
Enrollment StartOct 25, 2017
Primary CompletionOct 28, 2021
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 9.4 years ago

Interventions

Tadalafil 20 MGdrug

Multi-center, double-blind, 1:1 randomized, placebo-controlled clinical trial with Tadalafil

Placebo 20 MGdrug

Multi-center, double-blind, 1:1 randomized, placebo-controlled clinical trial with Tadalafil