Effect of Phosphodiesterase-5 Inhibition With Tadalafil on SystEmic Right VEntricular Size and Function

• Status: Active, not recruiting
• Trial end date: 2021-10-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Inselspital, Berne
• Collaborator: Swiss National Science Foundation
• Treatments: Tadalafil

Criteria

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 or Glucose-Galactose-Malabsorption

• Participation at another clinical trial in which the primary endpoint has not been reached.