The Oxford Marfan Trial Version 1.0

• Research type

  Research Study

• Full title

  A randomised, double-blind, placebo-controlled pilot trial of irbesartan, doxycycline and a combination on markers of vascular dysfunction in the Marfan syndrome, using cardiovascular magnetic resonance imaging

• IRAS ID

  67805

• Contact name

  J C Forfar

• Sponsor organisation

  Clinical Trials Research Governance

• Eudract number

  2010-023612-14

• Research summary

  The Marfan syndrome is a genetic condition which affects around 1 in 5000 people. Many people with the Marfan syndrome develop weakening of major blood vessels, such as the aorta, for which surgery is often the only option to prevent serious problems. There is a clear need for a less invasive, preventative treatment strategy. Existing medications used to treat other problems may offer a solution. They may help to improve arterial elastic function and so may protect the arteries from weakening. This trial will test two drugs, called irbesartan and/or doxycycline, in people with the Marfan syndrome using a randomised, double blind, placebo-controlled trial design. Cardiovascular magnetic resonance (CMR) imaging will be used to assess the response of the aorta to these drugs. Other non-invasive tests of peripheral blood vessels and blood samples will help to elucidate the Mechanisms of action of these drugs. Each study participant will be involved in the trial for 6 months. This trial is being conducted by investigators at the Department of Cardiovascular Medicine, University of Oxford and is funded by the Oxford Biomedical research Centre.

• REC name

  South West - Central Bristol Research Ethics Committee

• REC reference

  13/SW/0006

• Date of REC Opinion

  8 Mar 2013

• REC opinion

  Further Information Favourable Opinion