Condition category
Not Applicable
Date applied
12/02/2010
Date assigned
06/04/2010
Last edited
01/07/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.rbht.nhs.uk

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

Results - basic reporting

Publication summary

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24289736

Publication citations

  1. 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.

Additional files

Editorial Notes