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This study aims to assess whether treatment with a drug called spironolactone, which is an aldosterone inhibitor, can improve ability to cope with exertion, quality of life and ability of the heart to relax better in symptomatic patients with atrial fibrillation with preserved pumping capacity.
IMPRESS-AF study is a double-blinded randomised placebo-controlled trial of 2-year treatment with an aldosterone antagonist, spironolactone (25mg once daily) vs placebo in 250 patients with symptomatic chronic atrial fibrillation and preserved left ventricular contractility (both added to the current optimised care). The trial will establish impact of spironolactone on the primary outcome of exercise tolerance (peak oxygen consumption on cardiopulmonary exercise testing) and secondary outcomes: (i) health-related quality of life (assessed using the validated Minnesota Living with Heart Failure and EuroQol EQ-5D questionnaires self-completed by patients), and (ii) left ventricular diastolic function (E/e' ratio on echocardiography) - all assessed at baseline and at 2 years; (iii) rates of all-cause hospitalisations during 2-year follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spironolactone | Experimental | Spironolactone 25 mg once daily for 2 years |
|
| Placebo | Placebo Comparator | Matched placebo once daily for 2 years |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spironolactone | Drug | 25 mg once daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Exercise tolerance (cardiopulmonary exercise testing) | Improvement in exercise tolerance (assessed using peak oxygen consumption on cardiopulmonary exercise testing) | 2 years of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life (MLWHF) | Improvement in quality of life assessed using MLWHF questionnaire | 2 years of treatment |
| Quality of life (EQ-5D) | Improvement in quality of life assessed using EQ-5D questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregory YH Lip, MD | University of Birmingham | Principal Investigator |
| Eduard Shantsila, PhD | University of Birmingham | Principal Investigator |
| Paulus Kirchhof, PhD | University of Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Birmingham Institute of Cardiovascular Sciences | Birmingham | West Midlands | B18 7QH | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32909497 | Derived | Shantsila E, Shahid F, Sun Y, Deeks J, Calvert M, Fisher JP, Kirchhof P, Gill PS, Lip GYH. Spironolactone in Atrial Fibrillation With Preserved Cardiac Fraction: The IMPRESS-AF Trial. J Am Heart Assoc. 2020 Sep 15;9(18):e016239. doi: 10.1161/JAHA.119.016239. Epub 2020 Sep 10. | |
| 27707827 | Derived | Shantsila E, Haynes R, Calvert M, Fisher J, Kirchhof P, Gill PS, Lip GY. 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 Oct 5;6(10):e012241. doi: 10.1136/bmjopen-2016-012241. |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D013148 | Spironolactone |
| ID | Term |
|---|---|
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 |
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| Placebo | Drug | Visually identical to spironolactone, once daily |
|
| 2 years of treatment |
| Left ventricular diastolic function | Improvement in diastolic function assessed using echocardiography (E/e' ratio) | 2 years of treatment |
| Exercise tolerance (6-minute walk test) | Improvement in exercise tolerance (assessed using 6-minute walk test) | 2 years of treatment |
| Rates of all-cause hospitalisations | 2 years of treatment |
| Spontaneous return to sinus rhythm on electrocardiogram | 2 years of treatment |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |