Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2025-12-25 @ 3:13 AM
NCT ID:
NCT02010905
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02010905
Study Brief:
Protocol Section:
NCT02010905