right heart dysfunction right ventricular dysfunction due to congenital heart disease
Conditions
Interventions
After randomisation one group (n=60) will receive 150mg losartan once daily for
two years. The other group will receive placebo in the same regimen.
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: adult patients with Tetralogy of Fallot with right ventricular dysfunction, defined as right ventricular ejection fraction
Exclusion criteria
Exclusion criteria: - Incapable of giving informed consent - Hypersensitivity to losartan or any of its help substances - Contraindication 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 > 5,5 mmol/L - Moderate to severe liver disease: Child Pugh class B or C - Raised plasma transaminases level > three times upper normal limit - Current treatment of hypertension with an ACE-inhibitor or ARB, which cannot be discontinued - Pregnant or nursing women - Desire to have children within the study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the primary endpoint of the proposed study is difference in change in RV ejection fraction, determined by CMR, between the treatment and the control group at two years follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| to determine whether the use of valsartan chances: 1. RV and LV volumes mass, (and ejection-fraction) 2. hospitalization for heart failure 3. death 4. pulmonary regurgitation 5. the prevalence of supra ventricular arrhythmias 6. the serum neurohormone levels 7. NYHA class? 8. circulating microRNA's 9. quality of life? 10. VO2max | — |
Countries
Netherlands
Outcome results
None listed