IMproved exercise tolerance in patients with PReserved Ejection fraction by Spironolactone on myocardial fibrosiS in Atrial Fibrillation rationale and design of the IMPRESS-AF randomised controlled trial.

Shantsila E; Haynes R; Calvert M; Fisher J; Kirchhof P; Gill PS; Lip GY.

BMJ Open. 6(10):e012241, 2016 10 05.

INTRODUCTION: Patients with atrial fibrillation frequently suffer from
heart failure with preserved ejection fraction. At present there is no
proven therapy to improve physical capacity and quality of life in
participants with permanent atrial fibrillation with preserved left
ventricular contractility.

OBJECTIVE: The single-centre IMproved exercise tolerance In heart failure
With PReserved Ejection fraction by Spironolactone On myocardial fibrosiS
In Atrial Fibrillation (IMPRESS-AF) trial aims to establish whether
treatment with spironolactone as compared with placebo improves exercise
tolerance (cardiopulmonary exercise testing), quality of life and
diastolic function in patients with permanent atrial fibrillation.

METHODS AND ANALYSIS: A total of 250 patients have been randomised in
this double-blinded trial for 2-year treatment with 25 mg daily dose of
spironolactone or matched placebo. Included participants are 50 years old
or older, have permanent atrial fibrillation and ejection fraction >55%.
Exclusion criteria include contraindications to spironolactone, poorly
controlled hypertension and presence of severe comorbidities with life
expectancy <2 years. The primary outcome is improvement in exercise
tolerance at 2 years and key secondary outcomes include quality of life
(assessed using the EuroQol EQ-5D-5L (EQ-5D) and Minnesota Living with
Heart Failure (MLWHF) questionnaires), diastolic function and all-cause

ETHICS AND DISSEMINATION: The study has been approved by the National
Research and Ethics Committee West Midlands-Coventry and Warwickshire (REC
reference number 14/WM/1211). The results of the trial will be published
in an international peer-reviewed journal.