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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.
BMJ Open. 2016 10 05; 6(10):e012241.BO

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.

Authors+Show Affiliations

University of Birmingham Institute of Cardiovascular Sciences, City Hospital, Birmingham, UK.University of Birmingham Institute of Cardiovascular Sciences, City Hospital, Birmingham, UK.Department of Primary Care Clinical Sciences, Institute of Applied Health Research, University of Birmingham, Birmingham, UK.School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, UK.University of Birmingham Institute of Cardiovascular Sciences, City Hospital, Birmingham, UK Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, UK.Department of Primary Care Clinical Sciences, Institute of Applied Health Research, University of Birmingham, Birmingham, UK.University of Birmingham Institute of Cardiovascular Sciences, City Hospital, Birmingham, UK.

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

27707827

Citation

Shantsila, Eduard, et al. "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." BMJ Open, vol. 6, no. 10, 2016, pp. e012241.
Shantsila E, Haynes R, Calvert M, et al. 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. BMJ Open. 2016;6(10):e012241.
Shantsila, E., Haynes, R., Calvert, M., Fisher, J., Kirchhof, P., Gill, P. S., & Lip, G. Y. (2016). 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. BMJ Open, 6(10), e012241. https://doi.org/10.1136/bmjopen-2016-012241
Shantsila E, et al. 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. BMJ Open. 2016 10 5;6(10):e012241. PubMed PMID: 27707827.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Shantsila,Eduard, AU - Haynes,Ronnie, AU - Calvert,Melanie, AU - Fisher,James, AU - Kirchhof,Paulus, AU - Gill,Paramjit S, AU - Lip,Gregory Y H, Y1 - 2016/10/05/ PY - 2016/10/7/entrez PY - 2016/10/7/pubmed PY - 2017/12/7/medline KW - atrial fibrillation KW - exercise tolerance KW - heart failure with preserved ejection fraction KW - spironolactone SP - e012241 EP - e012241 JF - BMJ open JO - BMJ Open VL - 6 IS - 10 N2 - 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. SN - 2044-6055 UR - https://www.unboundmedicine.com/medline/citation/27707827/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_ L2 - http://bmjopen.bmj.com/cgi/pmidlookup?view=long&amp;pmid=27707827 DB - PRIME DP - Unbound Medicine ER -