Angiotensin II Receptor Blockers in patients with systemic right ventricles

Completed

• Conditions: Transposition of the great arteries, systemic right ventricle; Circulatory System

• Registration Number: ISRCTN52352170
• Lead Sponsor: Academic Medical Center (AMC) (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09-28
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• 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 consen
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 more than 250 µmol/L
8. Plasma potassium level more than 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 Angiotensin Converting Enzyme (ACE) inhibitors

Study & Design

• Study Type: Interventional
• Study Design: Not specified