The effects of irbesartan on aortic dilatation in Marfan's syndrome
| ISRCTN | ISRCTN90011794 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN90011794 |
| Secondary identifying numbers | 1 |
- Submission date
- 12/02/2010
- Registration date
- 06/04/2010
- Last edited
- 16/12/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Michael Mullen
Scientific
Scientific
Royal Brompton and Harefield NHS Foundation Trust
Sydney Street
London
SW3 6NP
United Kingdom
| Phone | +44 (0)20 7351 8600 |
|---|---|
| m.mullen@rbht.nhs.uk |
Study information
| Study design | Prospective randomised placebo-controlled double-blind multi-centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A prospective, randomised, placebo-controlled double blind, multicentre study of the effects of irbesartan on aortic dilatation in Marfan's syndrome |
| Study acronym | AIMS |
| Study objectives | To investigate the effects of irbesartan on aortic dilatation in Marfan's syndrome. |
| Ethics approval(s) | UK Research Ethics Committee pending approval as of 12/02/2010. |
| Health condition(s) or problem(s) studied | Marfan's syndrome |
| Intervention | 1. Run in Phase: 75 mg open label irbesartan (1 month) - all patients 2. Month 2: 150 mg irbesartan/placebo once daily (o.d.) 3. Months 3 - 48: 300 mg irbesartan/placebo o.d. The proposed target doses are 300 mg o.d. for patients greater than 50 kg and 150 mg o.d. for patients less than 50 kg. Maximum follow up will be 60 months. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Irbesartan |
| Primary outcome measure | Absolute change in aortic root diameter per year measured by echocardiography |
| Secondary outcome measures | 1. Change in z score per year - where the z score is calculated on aortic root and body surface area (BSA) 2. Clinical events and requirement for surgery including aortic dissection confirmed on transoesophageal echocardiography (TOE), magnetic resonance imaging (MRI) or computed tomography (CT) 3. Aortic dissection requiring emergency surgery 4. Aortic dissection requiring elective surgery 5. Aortic dilatation requiring elective or emergency surgery 6. Sudden death 7. Cerebrovascular accident 8. Cardiovascular death 9. Aortic regurgitation requiring surgery 10. Death during surgery for any of the above 11. Left ventricular function determined by volumes and ejection fraction 12. Left ventricular mass measurements 13. Assessment of valvular function 14. Cardiac rhythm and voltage 15. Height 16. Arm span and lower segment measurements 17. Fibrillin-1 mutation analysis will be performed in those patients whose mutation status is unknown All outcomes are measured annually. |
| Overall study start date | 01/09/2010 |
| Completion date | 03/03/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | 490 |
| Total final enrolment | 192 |
| Key inclusion criteria | 1. Clinically confirmed Marfan's syndrome 2. Aorta dilated above the normal 95th percentile 3. Greater than 6 and less than 40 years of age, either sex 4. Provision of informed consent |
| Key exclusion criteria | 1. Previous cardiac or aortic surgery 2. Planned cardiac or aortic surgery 3. Aortic diameter greater than or equal to 4.5 cm 4. Haemodynamically significant, severe valvular disease 5. Heart failure (defined as left ventricular ejection fraction [LVEF] less than 40%) 6. Therapeutic use of angiotensin converting enzyme (ACE) inhibitors/angiotensin-II receptor antagonist 7. Previous recorded adverse reaction to the trial medication (irbesartan) 8. Female patient who is pregnant, planning pregnancy or not using reliable contraception 9. Impaired renal function |
| Date of first enrolment | 01/09/2010 |
| Date of final enrolment | 03/03/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Royal Brompton and Harefield NHS Foundation Trust
London
SW3 6NP
United Kingdom
SW3 6NP
United Kingdom
Sponsor information
Royal Brompton and Harefield NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Sydney Street
London
SW3 6NP
England
United Kingdom
| Phone | +44 (0)20 7351 8121 |
|---|---|
| w.butcher@rbht.nhs.uk | |
| Website | http://www.rbht.nhs.uk |
"ROR" |
https://ror.org/02218z997 |
Funders
Funder type
Charity
British Heart Foundation (BHF) (UK)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- the_bhf, The British Heart Foundation, BHF
- Location
- United Kingdom
Marfan Trust (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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/12/2013 | Yes | No | |
| Results article | results | 21/12/2019 | 16/12/2019 | Yes | No |
Editorial Notes
16/12/2019: Publication reference and total final enrolment number added.
