The effects of angiotensin 2 blockade on arterial stiffness in patients with Marfan Syndrome: a comparison with beta blockade and placebo (BETA BLOCKER)
| ISRCTN | ISRCTN82800078 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN82800078 |
| Protocol serial number | N0544125986 |
| Sponsor | Department of Health |
| Funder | Cambridge Consortium - Addenbrookes (UK) |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 20/04/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Morris J Brown
Scientific
Scientific
Queen Mary University of London
Mile End Road
London
E1 4NS
United Kingdom
| Phone | +44 20 7882 5555 |
|---|---|
| morris.brown@qmul.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised placebo controlled crossover group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | The effects of angiotensin 2 blockade on arterial stiffness in patients with Marfan Syndrome: a comparison with beta blockade and placebo (BETA BLOCKER) |
| Study objectives | Do angiotensin 2 antagonists reduce arterial stiffness in patients with Marfan Syndrome when compared to patients taking beta blockade or placebo. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Marfan syndrome |
| Intervention | Patients with Marfan Syndrome (MFS) develop dissection of the aorta and aortic valve incompetence which can lead to premature death. Administration of beta adrenoceptor blockers slows aortic dilation and in one study reduced the number of cardiovascular events when compared to placebo. In the light of new trial evidence and some in vitro experimentation it is possible that a new class of drug, the angiotensin 2 antagonist may have an superior benefit to the beta blocker in these patients. We aim to test this hypothesis by administering this drug in the setting of a clinical trial and measuring the response using detailed arterial stiffness measurements. In this way we hope to compare the beta blocker to the angiotensin 2 antagonist. This may subsequently form the basis for a larger multicentre trial. Cross-over design comparing beta blocker + angiotensin 2 or placebo |
| Intervention type | Other |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 20/03/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 30 Years |
| Sex | All |
| Target sample size at registration | 30 |
| Key inclusion criteria | 30 patients aged 18-30 |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 21/03/2003 |
| Date of final enrolment | 20/03/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Box No 110
Cambridge
CB2 2QQ
United Kingdom
CB2 2QQ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
19/04/2018: No publications found, study status unverified.
4/03/2016: No publications found, verifying study status with principal investigator.
