Contact information
Type
Scientific
Primary contact
Dr Michael Mullen
ORCID ID
Contact details
Royal Brompton and Harefield NHS Foundation Trust
Sydney Street
London
SW3 6NP
United Kingdom
+44 (0)20 7351 8600
m.mullen@rbht.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1
Study information
Scientific title
A prospective, randomised, placebo-controlled double blind, multicentre study of the effects of irbesartan on aortic dilatation in Marfan's syndrome
Acronym
AIMS
Study hypothesis
To investigate the effects of irbesartan on aortic dilatation in Marfan's syndrome.
Ethics approval
UK Research Ethics Committee pending approval as of 12/02/2010.
Study design
Prospective randomised placebo-controlled double-blind multi-centre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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 names
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 trial start date
01/09/2010
Overall trial end date
03/03/2017
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
490
Participant 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
Recruitment start date
01/09/2010
Recruitment end date
03/03/2017
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Brompton and Harefield NHS Foundation Trust
London
SW3 6NP
United Kingdom
Sponsor information
Organisation
Royal Brompton and Harefield NHS Foundation Trust (UK)
Sponsor details
Sydney Street
London
SW3 6NP
United Kingdom
+44 (0)20 7351 8121
w.butcher@rbht.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
British Heart Foundation (BHF) (UK)
Alternative name(s)
BHF
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
United Kingdom
Funder name
Marfan Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24289736
Publication citations
-
Protocol
Mullen MJ, Flather MD, Jin XY, Newman WG, Erdem G, Gaze D, Valencia O, Banya W, Foley CE, Child A, A prospective, randomized, placebo-controlled, double-blind, multicenter study of the effects of irbesartan on aortic dilatation in Marfan syndrome (AIMS trial): study protocol., Trials, 2013, 14, 408, doi: 10.1186/1745-6215-14-408.