EPLERAF-Study: Eplerenone in the Prevention of Atrial Fibrillation Recurrences After Cardioversion

Study Overview
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Brief Summary
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The purpose of this study is to determine whether Eplerenone reduces atrial fibrillation (AF) recurrences within the first 8 weeks after electrical cardioversion of persistent AF.

Official Title
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EPLERAF-Study: Eplerenone in the Prevention of Atrial Fibrillation Recurrences After Cardioversion

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Drug: Eplerenone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Persistent atrial fibrillation (AF), AF persistence for > 7 days but < 1 year Total AF history < 2 years Written informed consent of the patient Age ≥18 years Female patients are sterilised or postmenopausal or apply an adequate method for contraception (Pearl index <1%) and have a negative pregnancy test (ß-HCG) and do not breastfeed/nurse. Exclusion Criteria: Hemodynamic instability or symptoms not allowing cardioversion to be delayed for 3 weeks Myocardial infarction within the last 3 months Heart failure NYHA class III - IV Uncontrolled hypertension, defined as a systolic blood pressure > 160 mm Hg and/or a diastolic blood pressure > 95 mm Hg (anti-hypertensive treatment is allowed). Pre-treatment with an aldosterone antagonist or other potassium sparing diuretics Instable angina pectoris Use of Digitalis Use of class I or class III antiarrhythmic drugs (must be stopped at least 5 half-life before) Contraindication or hypersensitivity to ß-blockers Open heart surgery within the last 3 months Pregnancy Acute and reversible illnesses Acute and chronic infection Alcohol or drug abuse or a severe progressive extracardiac disease Untreated manifest and latent hyper- or hypothyroidism or < 3 months peripheral euthyroidism (normal fT3) Moderate to severe renal insufficiency (Creatinine clearance less than 50 ml/min) Patients with liver cirrhosis (Child-Pugh class C) Co-administration of strong CYP3A4 inhibitors (e.g. Itraconazole, Ketoconazole, Ritonavir, Nelfinavir, Clarithromycin, Telithromycin and Nephazodon) Hypersensitivity against Eplerenone and/or one of the other components of the tablet (see Fachinformation) Serum potassium > 5 mmol/l Patients unlikely to comply with the protocol

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Eplerenone treatment | Drug: Eplerenone<br>* 50 mg per day<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* 50 mg per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrial fibrillation recurrence after electrical cardioversion of atrial fibrillation |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sinus rhythm within eplerenone treatment before planned electrical cardioversion |  | 3 weeks | 
| Cardioversion success |  | at least one sinus beat | 
| Time to recurrence of atrial fibrillation |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atrial fibrillation, electrical cardioversion, prevention of atrial fibrillation recurrence, mineralocorticoid receptor blocker, eplerenone, Recurrence of atrial fibrillation after cardioversion