EPLERAF-Study: Eplerenone in the Prevention of Atrial Fibrillation Recurrences After Cardioversion (EPLERAF)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00647192
Recruitment Status :
(Inclusion rate too low. Recruitment of further study centers too costly.)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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
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)