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IMPRESS-AF trial, version 1.0

  • Research type

    Research Study

  • Full title

    IMPRESS-AF: IMproved exercise tolerance in patients with PReserved Ejection fraction by Spironolactone on myocardial fibrosiS in Atrial Fibrillation

  • IRAS ID

    138338

  • Contact name

    Eduard Shantsila

  • Contact email

    e.shantsila@bham.ac.uk

  • Sponsor organisation

    University of Birmingham

  • Eudract number

    2014-003702-33

  • Duration of Study in the UK

    3 years, 5 months, 30 days

  • Research summary

    Atrial fibrillation is a type of heart rhythm disorder called an ‘arrhythmia’. The heart of a patient with atrial fibrillation is often unable to supply enough blood to their body (a condition called ‘heart failure’). In about half of all heart failure patients the heart contracts reasonably well, but it does not relax properly because it is very stiff. These patients have a poor quality of life and a high risk of death. However, effective treatments for this condition are lacking. So there is a clear need to find beneficial therapies for such patients. The reason why patients with atrial fibrillation tend to develop stiff hearts that fill poorly and develop heart failure is not known, but high levels of aldosterone have been suggested to play an important role. Aldosterone is normally produced by the adrenal glands, travels in the blood, and has a wide range of effects throughout the body. We think that raised aldosterone levels may explain the stiffening of the heart and its poor filling in patients with atrial fibrillation and heart failure. The effects of aldosterone can be blunted with the drug spironolactone, and with this clinical trial we want to find out if giving spironolactone to patients with atrial fibrillation enhances the way their hearts relax and so increases their ability to perform exercise, improves their quality of life. It is well known that patients who suffer from heart failure with normal pumping and atrial fibrillation do worse than those with heart failure with normal pumping but have a normal heart rhythm. However, patients with atrial fibrillation are normally excluded from studies of heart failure with normal pumping. In light of this, in the present project we will focus our attention on those patients who have atrial fibrillation.

  • REC name

    West Midlands - Coventry & Warwickshire Research Ethics Committee

  • REC reference

    14/WM/1211

  • Date of REC Opinion

    7 Jan 2015

  • REC opinion

    Further Information Favourable Opinion