SERVE - Effect of phosphodiesterase-5 inhibition with Tadalafil on SystEmic Right VEntricular size and function - Projekt

Projekt

SERVE - Effect of phosphodiesterase-5 inhibition with Tadalafil on SystEmic Right VEntricular size and function

Abgeschlossen · 2017 bis 2021

Engel Reto, Gemperle Michaela

Art

Klinische Forschung

Reichweite

Multizentrisch, KSSG als teilnehmendes Zentrum

Bereiche

Kardiologie

Status

Abgeschlossen

Start

2017

Ende

2021

Finanzierungsart

SNF

Studiendesign

multi-center, double-blind, randomized, placebo-controlled clinical superiority Trial, Clinical study Phase 3

Webseite

http://www.clinicaltrials.gov, SNCTP

Kurzbeschreibung/Zielsetzung

This study assesses in a pilot trial the effect of PDE-5 inhibition with Tadalafil on RV size and function, exercise capacity and neurohumoral activation in adults with a systemic RV over a 3-year follow-up period.
Included patients: Adults (≥18 years) with a systemic RV due to D-TGA repaired with an atrial switch procedure or due to ccTGA.
Excluded: myocardial infarction, stroke, or open heart surgery in the previous 3 months; expected heart transplant within the next 6 months

Primary endpoint: Change in mean end-systolic RV volumes (RV ESV) from baseline to study end at 3 years
Secondary endpoints: Change in mean systemic RV ejection fraction (EF); Change in exercise capacity measured as peak VO2 during cardiopulmonary exercise testing and change in serum neurohormonal activation.