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

• Conditions: Recurrence of atrial fibrillation after electrical cardioversion of persistent atrial fibrillation.; MedDRA version: 9.1Level: LLTClassification code 10066582Term: Recurrent atrial fibrillation

• Registration Number: EUCTR2007-002119-17-DE
• Lead Sponsor: niversität des Saarlandes

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-22
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 220

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.
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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate whether Eplerenone reduces atrial fibrillation (AF) recurrences within the first 8 weeks after electrical cardioversion of persistent AF.;Secondary Objective: - To investigate whether Eplerenone delays atrial fibrillation (AF) recurrences within the first 8 weeks after electrical cardioversion of persistent AF.<br><br>- To investigate whether Eplerenone facilitates electrical or spontaneous cardioversion of persistent AF.;Primary end point(s): AF recurrence (documented, symptomatic or asymptomatic AF episodes > 30 seconds within the first 8 weeks after electrical cardioversion)