The effects of angiotensin 2 blockade and long acting nitrates on arterial stiffness in patients with Marfan Syndrome. A placebo controlled study (NITRATES)
| ISRCTN | ISRCTN28168217 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28168217 |
| Secondary identifying numbers | N0544129339 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 25/04/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
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
| Study design | Randomised placebo controlled crossover trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | The effects of angiotensin 2 blockade and long acting nitrates on arterial stiffness in patients with Marfan Syndrome. A placebo controlled study (NITRATES) |
| Study objectives | Angiotensin 2 antagonists and nitrates reduce arterial stiffness in patients with Marfan Syndrome. |
| 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 dissection 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 other classes of drug, the angiotensin 2 antagonist and the nitrates may have a superior benefit to the beta blocker in these patients. We aim to test this hypothesis by administering these drugs in the setting of a clinical trial and measuring the response using detailed arterial stiffness measurements. In this way we hope to compare the nitrate to the angiotensin 2 antagonist and placebo. This may subsequently form the basis for a larger multi centre trial. Cross-over design comparing nitrates + angiotensin or placebo. |
| Intervention type | Other |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 23/06/2003 |
| Completion date | 22/06/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Lower age limit | 18 Years |
| Upper age limit | 30 Years |
| Sex | Both |
| Target number of participants | 30 |
| Key inclusion criteria | 30 subjects aged 18-30 |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 23/06/2003 |
| Date of final enrolment | 22/06/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Box No 110
Cambridge
CB2 2QQ
United Kingdom
CB2 2QQ
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Research organisation
Cambridge Consortium - Addenbrooke's (UK)
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 |
Editorial Notes
25/04/2018: No publications found, study status unverified
04/03/2016: No publications found, verifying study status with principal investigator.
