Angiotensin II receptor blockers in patients with systemic right ventricles.
Phase 3
Withdrawn
- Conditions
- Transposition of the great arteriescongenitally corrected transposition of the great arteries10010394
- Registration Number
- NL-OMON30035
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 128
Inclusion Criteria
Systemic right ventricle
Adult (18 years or older)
Exclusion Criteria
Incapable of giving informed consent
Hypersensitivity to valsartan or any of its help substances
Known bilateral renal artery stenosis
Current symptomatic hypotension
Myocardial infarction, stroke or open-heart surgery in the previous four weeks
Previous heart transplant, or expected heart transplant within the next six months
Plasma creatinine level > 250 µmol/L
Plasma potassium level > 5,5 mmol/L
Pregnancy or breast feeding
Desire to have children within the study period
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Change in right ventricular function ejection fraction, determined by<br /><br>Cardiovascular Magnetic Resonance (CMR) (valsartan vs. placebo).</p><br>
- Secondary Outcome Measures
Name Time Method <p>changes congestive heart failure?<br /><br>changes the prevalence of supra-ventricular arrhythmias?<br /><br>changes in right ventricular function, determined by body surface mapping?<br /><br>changes the right ventricular volume?<br /><br>changes the peak oxygen consumption during exercise?<br /><br>changes the serum neurohormone levels?<br /><br>changes the quality of life and sport activity?<br /><br>changes the cardiac output and microcirculation?<br /><br>changes the number of deaths?</p><br>