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

Project

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

Completed · 2017 until 2021

Engel Reto, Gemperle Michaela

Type

Clinical Studies

Range

Multicentric, KSSG as participating partner

Units

Kardiologie

Status

Completed

Start Date

2017

End Date

2021

Financing

SNF

Study Design

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

Homepage

http://www.clinicaltrials.gov, SNCTP

Brief description/objective

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.