Ox- FAST Study (Oxford – Fibrates in Aortic Stenosis); Version 1.0

  • Research type

    Research Study

  • Full title

    Oxford-Fibrates in Aortic Stenosis Study: The effect of altering myocardial lipid content on cardiac physiology in patients with aortic stenosis

  • IRAS ID

    252047

  • Contact name

    Masliza Mahmod

  • Contact email

    masliza.mahmod@cardiov.ox.ac.uk

  • Sponsor organisation

    University of Oxford

  • Duration of Study in the UK

    3 years, 0 months, 0 days

  • Research summary

    Aortic Stenosis (AS) is a common condition mainly affecting the older population where the main heart valve(aortic valve) narrows over time. Once the valve narrows, the heart muscle must pump harder to keep blood flowing. This can lead to thickening of heart muscle and cause symptoms of chest pain, breathlessness and dizziness. Currently, the treatment of choice for patients with moderate-severe AS who experience symptoms is surgery. But for those who are not yet experiencing symptoms, there is no treatment option available.

    Research has shown that people with AS have excessive fat deposition which can be harmful to the heart muscle and cause reduced function of the heart. We would like to understand the changes to the heart muscle caused by this increased fat build up in AS. We are doing this by using fenofibrate, a fibrate drug that is used to treat high fat levels (triglycerides) in the blood to see how changes in the fat build up affect heart muscle function.

    Our study will include 62 patients with moderate-severe AS who do not yet experience any symptoms. Participants will be randomly assigned to receive either fenofibrate or dummy tablet. They will undergo cardiac magnetic resonance imaging (MRI)scans to assess the fat in the heart muscle before and after 6 months of treatment with the study medication.

    The study is funded by the British Heart Foundation and sponsored by University of Oxford. All study assessments will take place at John Radcliffe hospital, Oxford and will include 3-4 visits over a total duration of 7 months.

    The study, if successful, will help guide clinical doctors to find better treatment options for this condition.

  • REC name

    London - Surrey Research Ethics Committee

  • REC reference

    18/LO/1981

  • Date of REC Opinion

    17 Dec 2018

  • REC opinion

    Further Information Favourable Opinion