The AIMS Study
Research type
Research Study
Full title
A prospective, randomised, placebo-controlled, double blind, multi-centre study of the effects of Irbesartan on aortic dilatation in Marfan syndrome
IRAS ID
28875
Contact name
Michael Mullen
Sponsor organisation
Royal Brompton & Harefield NHS Foundation Trust
Eudract number
2010-019302-16
ISRCTN Number
Not Submitted
Research summary
This study is investigating a treatment for a potentially life threatening complication in patients with a genetically inherited disorder known as Marfan Syndrome (MFS). MFS affects three main systems in the body; the eyes, skeleton and cardiovascular system. MFS causes the main blood vessel in the heart called the aortic root to expand and this can cause it to tear and rupture. Without a life saving surgery to repair and/or replace the aortic root patients with MFS may die. The average age at death in an untreated MFS patient is thirty-two years. Commonly patients with MFS are treated with a medication called beta blockers which can slow the rate of expansion in the aorta, however, beta blockers are not always well tolerated and have serious side effects particularly in children. In this study we aim to investigate whether another drug called Irbesartan can reduce the amount the aorta expands. We hope this will provide a potentially life saving treatment to MFS patients. We aim to treat patients for a minimum of 36 months (3 years) with patients recruited at the start of the study being followed up for the maximum 60 month study period. We aim to follow the patients progress closely, and we will measure the rate in which the aorta expands through an imaging technique called echocardiography. This will enable us to compare the rate of expansion in the aorta in patients receiving the active drug versus those receiving the dummy or placebo drug.
REC name
London - Hampstead Research Ethics Committee
REC reference
10/H0720/28
Date of REC Opinion
4 May 2010
REC opinion
Favourable Opinion