Spironolactone in Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— IMPRESS-AF  

Official title:

Improved Exercise Tolerance in Participants With PReserved Ejection Fraction by Spironolactone on Myocardial Fibrosis in Atrial Fibrillation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02673463
• Other study ID #: RG_14-150
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: January 2015
• Est. completion date: March 2019

Study information

• Verified date: October 2018
• Source: University of Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 250
• Est. completion date: March 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Spironolactone
25 mg once daily
• Placebo
Visually identical to spironolactone, once daily

Locations

Country	Name	City	State
United Kingdom	University of Birmingham Institute of Cardiovascular Sciences	Birmingham	West Midlands

Sponsors (1)

Lead Sponsor	Collaborator
University of Birmingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exercise tolerance (cardiopulmonary exercise testing)	Improvement in exercise tolerance (assessed using peak oxygen consumption on cardiopulmonary exercise testing)	2 years of treatment
Secondary	Quality of life (MLWHF)	Improvement in quality of life assessed using MLWHF questionnaire	2 years of treatment
Secondary	Quality of life (EQ-5D)	Improvement in quality of life assessed using EQ-5D questionnaire	2 years of treatment
Secondary	Left ventricular diastolic function	Improvement in diastolic function assessed using echocardiography (E/e' ratio)	2 years of treatment
Secondary	Exercise tolerance (6-minute walk test)	Improvement in exercise tolerance (assessed using 6-minute walk test)	2 years of treatment
Secondary	Rates of all-cause hospitalisations		2 years of treatment
Secondary	Spontaneous return to sinus rhythm on electrocardiogram		2 years of treatment