Angiotensin II Receptor Blockers in patients with systemic right ventricles
| ISRCTN | ISRCTN52352170 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52352170 |
| Secondary identifying numbers | CVAL489ANL09 |
- 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
Scientific
Academic Medical Centre
Department of Cardiology
Room F3 - 115
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
| Phone | +31 (0)20 5666051 |
|---|---|
| b.j.bouma@amc.uva.nl |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/09/2006 |
| Completion date | 01/01/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
1105 AZ
Netherlands
Sponsor information
Academic Medical Center (AMC) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
"ROR" |
https://ror.org/03t4gr691 |
|---|
Funders
Funder type
Industry
Novartis Pharma B.V. (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/11/2010 | Yes | No | |
| Results article | results | 22/01/2013 | Yes | No |
