What question did this study set out to answer?

This trial aims to determine if spironolactone improves exercise tolerance, quality of life, and diastolic function in patients with atrial fibrillation and preserved ejection fraction.

October 1, 2016BMJ OpenOpen Access

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

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Why the study?

Does spironolactone improve exercise tolerance in patients with permanent atrial fibrillation and preserved ejection fraction?

Key Points

This trial aims to determine if spironolactone improves exercise tolerance, quality of life, and diastolic function in patients with atrial fibrillation and preserved ejection fraction.
Randomized double-blind trial involving 250 patients aged 50 or older with permanent atrial fibrillation and ejection fraction >55%.
Participants received either 25 mg of spironolactone or matched placebo for 2 years.
The primary outcome is exercise tolerance improvement at 2 years, with secondary outcomes including quality of life and diastolic function.
Spironolactone treatment is expected to improve exercise tolerance over 2 years, as assessed through cardiopulmonary exercise testing.
Quality of life scores and diastolic function are also anticipated to show significant enhancements.

Structured PICO

Does spironolactone improve exercise tolerance in patients with permanent atrial fibrillation and preserved ejection fraction?

Population

250 patients aged 50 years or older with permanent atrial fibrillation and ejection fraction >55%. Exclusions include contraindications to spironolactone, poorly controlled hypertension, and severe comorbidities with life expectancy <2 years.

Intervention

Spironolactone 25 mg daily dose for 2 years

Comparator

Matched placebo for 2 years

Outcome

Improvement in exercise tolerance at 2 years (assessed by cardiopulmonary exercise testing)surrogate

The IMPRESS-AF trial will determine if spironolactone improves exercise tolerance and quality of life in patients with permanent atrial fibrillation and preserved ejection fraction.

Implication

Tests spironolactone in permanent AF with preserved EF; RCT leaves open effects on exercise tolerance and quality of life.

Abstract

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 hospitalisation. 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. TRIAL REGISTRATION NUMBERS: EudraCT2014-003702-33; NCT02673463; Pre-results.