Abstract | INTRODUCTION: OBJECTIVE: 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.
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Authors | Eduard Shantsila, Ronnie Haynes, Melanie Calvert, James Fisher, Paulus Kirchhof, Paramjit S Gill, Gregory Y H Lip |
Journal | BMJ open
(BMJ Open)
Vol. 6
Issue 10
Pg. e012241
(10 05 2016)
ISSN: 2044-6055 [Electronic] England |
PMID | 27707827
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/. |
Chemical References |
- Mineralocorticoid Receptor Antagonists
- Spironolactone
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Topics |
- Aged
- Atrial Fibrillation
(drug therapy, physiopathology)
- Diastole
(drug effects)
- Double-Blind Method
- Exercise Test
- Exercise Tolerance
(drug effects)
- Female
- Heart Failure
(drug therapy, physiopathology)
- Humans
- Male
- Middle Aged
- Mineralocorticoid Receptor Antagonists
(therapeutic use)
- Quality of Life
- Spironolactone
(therapeutic use)
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