Angiotensin II receptor blockers in patients with systemic right ventricles.

Conditions: Systemic right ventricle due to a congenitally or surgically corrected transposition of the great arteries.

Registration Number: NL-OMON21444

Lead Sponsor: Academic Medical CentreMeibergdreef 91105 AZ AmsterdamThe Netherlands

Brief Summary: /A

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 128

Inclusion Criteria

All adult patients with a systemic right ventricle due to a congenitally or surgically corrected transposition of the great arteries.

Exclusion Criteria

1. Incapable of giving informed consent;
2. Hypersensitivity to valsartan or any of its help substances;
3. Known bilateral renal artery stenosis;
4. Current symptomatic hypotension;
5. Myocardial infarction, stroke or open-heart surgery in the previous four weeks;
6. Previous heart transplant, or expected heart transplant within the next six months;
7. Plasma creatinine level > 250 µmol/L;
8. Plasma potassium level > 5,5 mmol/L;
9. Pregnant or nursing women (a pregnancy test is offered to every female patient within the fertile age);
10. Desire to have children within the study period;
11. Current treatment of hypertension with Angiotensin II receptor blockers or ACE inhibitors.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The change in right ventricular ejection fraction, determined by Cardiovascular Magnetic Resonance (CMR) (valsartan vs. placebo). In patients who are not eligible for CMR the right ventricular ejection fraction is determined by echocardiography.

Secondary Outcome Measures

Name	Time	Method
1. changes congestive heart failure?<br>2. changes the prevalence of supra-ventricular arrhythmias?<br>3. changes in right ventricular function, determined by body surface mapping?<br>4. changes the right ventricular volume?<br>5. changes the peak oxygen consumption during exercise?<br>6. changes the serum neurohormone levels?<br>7. changes the quality of life and sport activity?<br>8. changes the cardiac output and microcirculation?<br>9. changes the number of deaths?