Efficacy of Tadalafil on the size and function of the right heart ventriclein adults with a congenital heart disease, whose right ventricle insteadof the left venrticle pumps blood in the body's circulation system.
Phase 1
- Conditions
- Adults with congenital heart disease (CHD) and a right ventricle (RV) insubaortic (systemic) position.Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
- Registration Number
- EUCTR2016-004291-21-AT
- Lead Sponsor
- Insel Gruppe AG - Inselspital Universitätsklinik für Kardiologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 98
Inclusion Criteria
Adults (=18 years) with a systemic RV due to due to D-TGA repaired with an atrial switch procedure or due to ccTGA
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 98
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
No informed consent; myocardial infarction, stroke, or open heart
surgery in the previous 3 months; expected heart
transplant within the next 6 months; pregnant or nursing women;
severe renal insufficiency; hypersensitivity to
Tadalafil; known allergy to iodinated or Gadolinium-based contrast
agents.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: This study assesses in a double-blind, randomized, placebo-controlled<br>multi-center pilot trial the effect of PDE-5 inhibition with Tadalafil on<br>right ventricle (RV) size and functionin adults with a systemic RV over<br>a 3-year follow-up period.;Secondary Objective: This study assesses in a double-blind, randomized, placebo-controlled<br>multi-center pilot trial the effect of PDE-5 inhibition with Tadalafil on<br>exercise capacity and neurohumoral activation in adults with a<br>systemic RV over a 3-year follow-up period.;Primary end point(s): Change in mean end-systolic RV volumes (RVESV) from baseline to study end,<br>measured by cardiovascular MRI or cardiac CT in patients with contraindication for MRI.;Timepoint(s) of evaluation of this end point: At 3 years of follow-up.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Change in mean systemic RV ejection fraction (EF); change in exercise capacity and change in serum<br>neurohormonal activation from baseline to study end.;Timepoint(s) of evaluation of this end point: At 3 years of follow-up.