Spironolactone in Atrial Fibrillation

Phase 4

• Conditions: Atrial Fibrillation
• Interventions: Drug: Placebo; Drug: Spironolactone

• Registration Number: NCT02673463
• Lead Sponsor: University of Birmingham

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2016-02-01
• Study First Submitted QC: 2016-02-03
• Study First Posted: 2016-02-04
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-10
• Last Update Posted: 2018-10-11
• Primary Completion: 2018-12
• Study Completion: 2019-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• Permanent AF
• Left ventricular ejection fraction >= 55% as established by echocardiography
• Able to perform cardio-pulmonary exercise testing using a cycling ergometer and complete quality of life questionnaires in English or in their native language.

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Exclusion Criteria

• Severe systemic illness (life expectancy <2 years)
• Severe chronic obstructive pulmonary disease (e.g., requiring home oxygen or chronic oral steroid therapy)
• Severe mitral/aortal valve stenosis/regurgitation
• Significant renal dysfunction (serum creatinine 220 µmol/L or above), anuria, active renal insufficiency, rapidly progressing or severe impairment of renal function, confirmed or suspected renal insufficiency in diabetic patients/ diabetic nephropathy
• Increase in potassium level to >5mmol/L
• Recent coronary artery bypass graft surgery (within 3 months)
• Use of aldosterone antagonist within 14 days before randomisation
• Use of or potassium sparing diuretic within 14 days before randomisation
• Systolic blood pressure >160 mm Hg
• Addison's disease
• Hypersensitivity to spironolactone or any of the ingredients in the product
• Any participant characteristic that may interfere with adherence to the trial protocol

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Matched placebo once daily for 2 years
Spironolactone	Spironolactone	Spironolactone 25 mg once daily for 2 years

Primary Outcome Measures

Name	Time	Method
Exercise tolerance (cardiopulmonary exercise testing)	2 years of treatment	Improvement in exercise tolerance (assessed using peak oxygen consumption on cardiopulmonary exercise testing)

Secondary Outcome Measures

Name	Time	Method
Quality of life (MLWHF)	2 years of treatment	Improvement in quality of life assessed using MLWHF questionnaire
Quality of life (EQ-5D)	2 years of treatment	Improvement in quality of life assessed using EQ-5D questionnaire
Rates of all-cause hospitalisations	2 years of treatment
Left ventricular diastolic function	2 years of treatment	Improvement in diastolic function assessed using echocardiography (E/e' ratio)
Exercise tolerance (6-minute walk test)	2 years of treatment	Improvement in exercise tolerance (assessed using 6-minute walk test)
Spontaneous return to sinus rhythm on electrocardiogram	2 years of treatment

Trial Locations

Locations (1)

University of Birmingham Institute of Cardiovascular Sciences; 🇬🇧 Birmingham, West Midlands, United Kingdom