EPLERAF-Studie: Eplerenon in der Prävention von Vorhofflimmer-Rezidiven nach Kardioversion /[EPLERAF-Study: Eplerenone in the prevention of atrial fibrillation recurrences after cardioversion] - EPLERAF-Studie

niversität des Saarlandes0 个研究点目标入组 220 人开始时间: 2007年8月22日最近更新: 2012年3月19日

试验速览

暂无简介。

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

•a)Hemodynamic instability or symptoms not allowing cardioversion to be delayed for 3 weeks
•b)Myocardial infarction within the last 3 months
•c)Heart failure NYHA class III – IV
•d)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).
•e)Pre-treatment with an aldosterone antagonist or other potassium sparing diuretics
•f)Instable angina pectoris
•g)Use of Digitalis
•h)Use of class I or class III antiarrhythmic drugs (must be stopped at least 5 half-life before)
•i)Contraindication or hypersensitivity to ß-blockers
•j)Open heart surgery within the last 3 months
•k)Pregnancy
•l)Acute and reversible illnesses
•m)Acute and chronic infection
•n)Alcohol or drug abuse or a severe progressive extracardiac disease
•o)Untreated manifest and latent hyper- or hypothyreodism or < 3 months peripheral euthyrodidism (normal fT3)
•p)Moderate to severe renal insufficiency (Creatinine clearance less than 50 ml/min)
•q)Patients with liver cirrhosis (Child-Pugh class C)
•r)Co-administration of strong CYP3A4 inhibitors (e.g. Itrakonazol, Ketokonazol, Ritonavir, Nelfinavir, Klaritromycin, Telitromycin and Nephazodon)
•s)Hypersensitivity against Eplerenone and/or one of the other components of the tablet (see Fachinformation)
•t)Serum potassium > 5 mmol/l
•u)Patients unlikely to comply with the protocol

发起方

niversität des Saarlandes