Effect of spironolactone on ability to exercise and heart stiffness in people with irregular heart beats (atrial fibrillation) and normal pumping capacity of the heart

• Conditions: Atrial fibrillation with preserved left ventricular systolic function and normal levels of the brain natriuretic peptide.; MedDRA version: 18.0Level: PTClassification code 10003658Term: Atrial fibrillationSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 18.0Level: LLTClassification code 10069211Term: Diastolic heart failureSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 18.0Level: LLTClassification code 10008908Term: Chronic heart failureSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2014-003702-33-GB
• Lead Sponsor: niversity of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-02
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

Eligible study patients will be
•Age 50 years old or over
•Permanent AF as defined by the European Society of Cardiology (ESC) criteria
•Normal BNP levels (<100 pg/mL)
•Ability to understand and complete questionnaires (with or without use of a
translater/translated materials).

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 125
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 125

Exclusion Criteria

•Severe systemic illness with life expectancy of less than 2 years from
screening
•Left ventricular ejection fraction (LVEF) <50% (echocardiography)
•Severe chronic obstructive pulmonary disease (COPD) (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)
•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
•Any participant characteristic that may interfere with adherence to the
trial protocol

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: People with an irregular heartbeat can find it difficult to exercise and may experience shortness of breath or tiredness because the heart cannot relax properly. This research is trying to find out whether taking a small dose of a drug called Spironolactone can improve the ability to exercise. Spironolactone works as a mild water tablet and is a well-known drug that seems to improve heart function.;Secondary Objective: The study also aims to find out if the treatment with spironolactone can improve the capacity of the heart to relax better, improve quality of life and to reduce needs for hospital admissions.;Primary end point(s): Improvement in exercise tolerance at 2 years. This will be assessed by difference between the study groups in peak VO2 on CPET.;Timepoint(s) of evaluation of this end point: End of 2 years of treatment with spironolactone or placebo.