Contact information
Type
Scientific
Primary contact
Dr B J Bouma
ORCID ID
Contact details
Academic Medical Centre
Department of Cardiology
Room F3 - 115
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
+31 (0)20 5666051
b.j.bouma@amc.uva.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CVAL489ANL09
Study information
Scientific title
Acronym
ARBs and systemic right ventricles.
Study hypothesis
Treatment with an angiotensin II receptor blocker (valsartan) stabilises or improves the functional performance of the systemic right ventricle.
Ethics approval
Ethics approval received from the local medical ethics committee
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Transposition of the great arteries, systemic right ventricle
Intervention
One group receives twice daily a 160 mg tablet of valsartan and the other group receives twice daily a placebo tablet.
Intervention type
Drug
Phase
Not Specified
Drug names
Valsartan
Primary outcome measure
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.
Secondary outcome measures
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?
Overall trial start date
01/09/2006
Overall trial end date
01/01/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All adult patients with a systemic right ventricle due to a congenitally or surgically corrected transposition of the great arteries.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
128
Participant 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
Recruitment start date
01/09/2006
Recruitment end date
01/01/2010
Locations
Countries of recruitment
Netherlands
Trial participating centre
Academic Medical Centre
Amsterdam
1105 AZ
Netherlands
Funders
Funder type
Industry
Funder name
Novartis Pharma B.V. (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21095266
2. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23247302
Publication citations
-
Protocol
van der Bom T, Winter MM, Bouma BJ, Groenink M, Vliegen HW, Pieper PG, van Dijk AP, Sieswerda GT, Roos-Hesslink JW, Zwinderman AH, Mulder BJ, Rationale and design of a trial on the effect of angiotensin II receptor blockers on the function of the systemic right ventricle., Am. Heart J., 2010, 160, 5, 812-818, doi: 10.1016/j.ahj.2010.08.005.
-
Results
van der Bom T, Winter MM, Bouma BJ, Groenink M, Vliegen HW, Pieper PG, van Dijk AP, Sieswerda GT, Roos-Hesselink JW, Zwinderman AH, Mulder BJ, Effect of valsartan on systemic right ventricular function: a double-blind, randomized, placebo-controlled pilot trial., Circulation, 2013, 127, 3, 322-330, doi: 10.1161/CIRCULATIONAHA.112.135392.