Angiotensin II receptor blockers in patients with systemic right ventricle.

Phase 1

• Conditions: Systemic right ventricle due to total transposition of the great arteries or congenitally corrected transposition of the great arteries

• Registration Number: EUCTR2006-002262-19-NL
• Lead Sponsor: ovartis Pharma B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-06-15
• Study Completion: 2006-09-02
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

All adult patients with a systemic right ventricle due to a congenitally or surgically corrected transposition of the great arteries are potentially eligible for this study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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
Pregnant or nursing women (a pregnancy test is offered to every female patient within the fertile age)
Desire to have children within the study period

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to determine whether Angiotensin II Receptor Blockers (valsartan) improve the functional (contractile, electrophysiologic) performance of the right ventricle in adult patients with a systemic right ventricle.;Secondary Objective: (1) changes congestive heart failure<br>(2) changes the onset of arrhythmias <br>(3) changes the right ventricular volume<br>(4) changes the peak oxygen consumption<br>(5) changes the serum neurohormone levels<br>(6) changes the quality of life <br>(7) changes the cardiac output and microcirculation<br>(8) changes the number of deaths<br>;Primary end point(s): Change in right ventricular ejection-fraction, determined by Cardiovascular Magnetic Resonance (CMR) (valsartan vs. placebo). If CMR is contra-indicated right ventricular ejection-fraction is determined by echocardiography.