Right Ventricular Dysfunction in Tetralogy of Fallot: Inhibition of the Renin-angiotensin-aldosterone System (Redefine)
Tetralogy of Fallot, Heart Defects, Congenital, Ventricular Dysfunction, Right
About this trial
This is an interventional treatment trial for Tetralogy of Fallot focused on measuring Losartan
Eligibility Criteria
Inclusion Criteria:
In order to be eligible to participate in this study, a subject must meet all of the following criteria: adult age and mentally competent; and Tetralogy of Fallot; and right ventricular dysfunction, defined as right ventricular ejection fraction 50% or lower as measured by Cardiovascular Magnetic Resonance Imaging (CMR). Not more than moderate tricuspid or pulmonary regurgitation or more than moderate pulmonary stenosis as measured by CMR or echocardiography.
Exclusion Criteria:
- Incapable of giving informed consent
- Hypersensitivity to losartan or any of its help substances
- Contraindications for CMR
- Previous or current angioedema whether or not in relation to the use of an ACE inhibitor or ARB
- Known bilateral renal artery stenosis
- Current symptomatic hypotension
- Estimated glomerular filtration rate of 30 ml/min or lower
- Plasma potassium level of 5,5 mmol/L or higher
- Moderate to severe liver disease: Child Pugh class B or C
- Raised plasma transaminases level more than three times upper normal limit
- Current treatment of hypertension with an ACE-inhibitor or ARB, which cannot be discontinued
- Current treatment with potassium chloride, trimethoprim, tacrolimus or cyclosporine which cannot be discontinued
- Pregnant or nursing women
- Desire to have children within the study period
Sites / Locations
- Academic Medical CenterRecruiting
- Universitair Medisch Centrum Groningen
- Leids Universitair Medisch CentrumRecruiting
- St Antonius ziekenhuis
- St Radboud Universitair Medisch Centrum
- Universitair Medisch Centrum Utrecht
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Losartan 150mg daily
Placebo 150mg daily
Losartan: white film-coated biconvex tablet (50mg) with a diameter of 8mm. One time daily three tablets.
Placebo: white film-coated biconvex tablet (50mg) with a diameter of 8mm. One time daily three tablets.