The AIMS Study [The Aortic Irbesartan Marfan Study]
The Royal Brompton NHS Foundation Trust together with 21 hospitals across England, Scotland, Wales and Northern Ireland are taking part in an important clinical trial investigating Marfan syndrome. Marfan syndrome is an inherited genetic condition affecting approximately 18,000 people in the UK, which can cause life threatening cardiovascular complications. The main purpose of this study is to evaluate how effective a blood pressure treatment called Irbesartan is for treating patients with Marfan syndrome. We wish to investigate whether this treatment can reduce the rate of expansion of the major blood vessel in the heart, known as the aorta. The study will also look at how safe the treatment is and how well it is tolerated.
AIMS Trial Progress report: January 2016
This British Heart Foundation funded national trial of Irbesartan versus placebo has been successful in recruiting 202 patients to the end of March 2015. Our decision to stop recruiting means that any new patient must have given consent to join the trial by March 31st. At the end of the trial, some patients will have been followed for 5 years, and the latest patients to join the trial will be followed up for a minimum of 3 years, with average follow up 4 years. This will provide the annual echocardiogram measurements needed for analysis.
The purpose of the AIMS Trial, now in its 5th year, is to test whether Irbesartan is more effective than placebo (sugar pill) in preserving the elastic fibres of the aortic wall, thus slowing or preventing aortic wall ballooning. Because the trial is also studying Marfan gene errors (mutations) and damaging serum proteins (TGFB), it stands a good chance of success in understanding the disease process. When the trial concludes in 2018, recommendations regarding best management will be made, based on reliable results from AIMS and other International trials.
Why is this important?
From previous publications, we know that the 2 groups (Irbesartan and control) start to show significant differences in the rate of aortic root dilation during the 2nd and 3rd year of medication. Thus, the AIMS trial has a good chance of proving that Irbesartan is better than a beta-blocker, which many of the control group are taking.
We are very grateful to all clinicians and patients for their considerable efforts in making this trial a success. The trial ends March 31st 2018, and analysis and publication will take place shortly after that. Other important publications will follow, analysing the data in various ways.
We will make every effort to ensure that patients remain in the trial for its duration. These patients should be reassured about the value of this study, since we do not yet have any robust clinical trial data to support the routine use of Irbesartan in Marfan syndrome. Our data will be contributed to an international study analysing the combined results from all similar international trials.
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