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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Systemic right ventricle due to prior atrial switch operations for complete transposition of the great arteries (D-TGA) due to congenitally corrected transposition of the great arteries (ccTGA).
Exclusion Criteria:
* Incapability of giving informed consent
* Myocardial infarction, stroke, or open heart surgery within the 3 months prior to baseline visit
* Expected heart transplant within the next 6 months starting from baseline
* Pregnant or nursing women (a pregnancy test is mandatory prior to randomization; women of childbearing potential must agree to use reliable contraception from randomization to end of study treatment)
* Severe renal insufficiency (Creatinine clearance ≤ 30 ml/min)
* Severe hepatic insufficiency (Child-Pugh-Class C)
* Hypotension with blood pressures \< 90/50 mmHg at the baseline visit
* Hypersensibility to Tadalafil
* Allergy to iodinated (in patients undergoing CMDCT) or Gadolinium-based (in patients undergoing CMR) contrast agents.
* Co-medication with nitrates
* Regular use of "poppers", i.e. alkyl nitrites, that are inhaled for recreational purposes, including as club drugs used at dance clubs.
* Co-medication with potent CYP3A4 inhibitors: Ketoconazole, Ritonavir, Rifampicin
* Co-medication with other PDE-5 inhibitors for erectile dysfunction during the last four weeks prior to baseline visit
* Medical history of Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)
* Hereditary Galactose intolerance, Lactase deficiency …