NCT02673463

Spironolactone in Atrial Fibrillation

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: University of Birmingham · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DRUG	Spironolactone	25 mg once daily
DRUG	Placebo	Visually identical to spironolactone, once daily

Timeline

• Start date: 2015-01-01
• Primary completion: 2018-12-01
• Completion: 2019-03-01
• First posted: 2016-02-04
• Last updated: 2018-10-11

Locations

1 site across 1 country: United Kingdom