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ISRCTN
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ISRCTN52352170
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ClinicalTrials.gov identifier
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Public title
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Angiotensin II Receptor Blockers in patients with systemic right ventricles
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Scientific title
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Acronym
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ARBs and systemic right ventricles.
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Serial number at source
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CVAL489ANL09
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Study hypothesis
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Treatment with an angiotensin II receptor blocker (valsartan) stabilises or improves the functional performance of the systemic right ventricle.
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Lay summary
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Ethics approval
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Ethics approval received from the local medical ethics committee
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Study design
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Randomised controlled trial
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Countries of recruitment
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Netherlands
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Disease/condition/study domain
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Transposition of the great arteries, systemic right ventricle
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Participants - inclusion criteria
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All adult patients with a systemic right ventricle due to a congenitally or surgically corrected transposition of the great arteries.
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Participants - exclusion criteria
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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
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Anticipated start date
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01/09/2006
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Anticipated end date
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01/01/2010
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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128
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Interventions
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One group receives twice daily a 160 mg tablet of valsartan and the other group receives twice daily a placebo tablet.
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Primary outcome measure(s)
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The change in right ventricular ejection fraction, determined by Cardiovascular Magnetic Resonance (CMR) (valsartan versus placebo). In patients who are not eligible for CMR the right ventricular ejection fraction is determined by echocardiography.
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Secondary outcome measure(s)
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1. Changes congestive heart failure?
2. Changes the prevalence of supra-ventricular arrhythmias?
3. Changes in right ventricular function, determined by body surface mapping?
4. Changes the right ventricular volume?
5. Changes the peak oxygen consumption during exercise?
6. Changes the serum neurohormone levels?
7. Changes the quality of life and sport activity?
8. Changes the cardiac output and microcirculation?
9. Changes the number of deaths?
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Sources of funding
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Novartis Pharma B.V. (The Netherlands)
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Trial website
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http://www.ccmo.nl
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Publications
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1. 2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21095266
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Contact name
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Dr
B J
Bouma
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Address
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Academic Medical Centre
Department of Cardiology
Room F3 - 115
Meibergdreef 9
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City/town
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Amsterdam
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Zip/Postcode
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1105 AZ
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Country
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Netherlands
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Tel
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+31 (0)20 5666051
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Email
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b.j.bouma@amc.uva.nl
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Sponsor
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Academic Medical Center (AMC) (The Netherlands)
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Address
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P.O. Box 22660
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City/town
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Amsterdam
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Zip/Postcode
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1100 DD
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Country
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Netherlands
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Date applied
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28/09/2006
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Last edited
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01/02/2011
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Date ISRCTN assigned
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28/09/2006
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