Angiotensin II Receptor Blockers in patients with systemic right ventricles

ISRCTN	ISRCTN52352170
DOI	https://doi.org/10.1186/ISRCTN52352170
Protocol serial number	CVAL489ANL09
Sponsor	Academic Medical Center (AMC) (The Netherlands)
Funder	Novartis Pharma B.V. (The Netherlands)

Submission date: 28/09/2006
Registration date: 28/09/2006
Last edited: 08/05/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr B J Bouma
Scientific

Academic Medical Centre
Department of Cardiology
Room F3 - 115
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Phone	+31 (0)20 5666051
Email	b.j.bouma@amc.uva.nl

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	ARBs and systemic right ventricles.
Study objectives	Treatment with an angiotensin II receptor blocker (valsartan) stabilises or improves the functional performance of the systemic right ventricle.
Ethics approval(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Valsartan
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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?
Completion date	01/01/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	128
Key inclusion criteria	All adult patients with a systemic right ventricle due to a congenitally or surgically corrected transposition of the great arteries.
Key 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
Date of first enrolment	01/09/2006
Date of final enrolment	01/01/2010

Locations

Countries of recruitment

Netherlands

Study participating centre

Academic Medical Centre

Amsterdam
1105 AZ
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	22/01/2013		Yes	No
Protocol article	protocol	01/11/2010		Yes	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes