EPLERAF-Study: Eplerenone in the Prevention of Atrial Fibrillation Recurrences After Cardioversion (EPLERAF)
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ClinicalTrials.gov Identifier: NCT00647192
(Inclusion rate too low. Recruitment of further study centers too costly.)
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
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)