The effects of irbesartan on aortic dilatation in Marfan's syndrome

ISRCTN	ISRCTN90011794
DOI	https://doi.org/10.1186/ISRCTN90011794
Protocol serial number	1
Sponsor	Royal Brompton and Harefield NHS Foundation Trust (UK)
Funders	British Heart Foundation (BHF) (UK), Marfan Trust (UK)

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

Royal Brompton and Harefield NHS Foundation Trust
Sydney Street
London
SW3 6NP
United Kingdom

Phone	+44 (0)20 7351 8600
Email	m.mullen@rbht.nhs.uk

Study information

Primary study design	Interventional
Study design	Prospective randomised placebo-controlled double-blind multi-centre trial
Secondary study design	Randomised controlled trial
Study type	Participant 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
Phase	Phase III
Drug / device / biological / vaccine name(s)	Irbesartan
Primary outcome measure(s)	Absolute change in aortic root diameter per year measured by echocardiography
Key secondary outcome measure(s)	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.
Completion date	03/03/2017

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	All
Target sample size at registration	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

United Kingdom
England

Study participating centre

Royal Brompton and Harefield NHS Foundation Trust

London
SW3 6NP
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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	21/12/2019	16/12/2019	Yes	No
Protocol article	protocol	01/12/2013		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

16/12/2019: Publication reference and total final enrolment number added.