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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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4 April 2022 |
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Main ID: |
EUCTR2006-002262-19-NL |
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Date of registration:
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15/06/2006 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Angiotensin II receptor blockers in patients with systemic right ventricle.
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Scientific title:
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Angiotensin II receptor blockers in patients with systemic right ventricle. |
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Date of first enrolment:
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07/08/2006 |
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Target sample size:
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128 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-002262-19 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Netherlands
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Contacts
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Key inclusion & exclusion criteria
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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
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Systemic right ventricle due to total transposition of the great arteries or congenitally corrected transposition of the great arteries
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Intervention(s)
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Product Name: Diovan
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
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Primary Outcome(s)
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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
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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.
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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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Secondary ID(s)
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CVAL489ANL09
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 07/08/2006
Contact:
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