Angiotensin II receptor blockers in patients with systemic right ventricle.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-002262-19-NL

Enrollment

128

Registered

2006-06-15

Start date

2006-08-07

Completion date

Unknown

Last updated

2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Product Name: Diovan Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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 (2) changes the onset of arrhythmias (3) changes the right ventricular volume (4) changes the peak oxygen consumption (5) changes the serum neurohormone levels (6) changes the quality of life (7) changes the cardiac output and microcirculation (8) changes the number of deaths ;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.	—

Measure

Time frame

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 (2) changes the onset of arrhythmias (3) changes the right ventricular volume (4) changes the peak oxygen consumption (5) changes the serum neurohormone levels (6) changes the quality of life (7) changes the cardiac output and microcirculation (8) changes the number of deaths ;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.

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Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026