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

University Hospital, Saarland

Status and phase

Terminated

Phase 2

Conditions

Atrial Fibrillation

Treatments

Drug: Eplerenone

Drug: Placebo

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00647192

EPLERAF-01

Version 09_D

EudraCT number: 2007-002119-17

Details and patient eligibility

About

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.

Enrollment

38 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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