Clinical trial NCT00647192: EPLERAF-Study: Eplerenone in the Prevention of Atrial Fibrillation Recurrences After Cardioversion
Official title: EPLERAF-Study: Eplerenone in the Prevention of Atrial Fibrillation Recurrences After Cardioversion
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation
electrical cardioversion
prevention of atrial fibrillation recurrence
mineralocorticoid receptor blocker
eplerenone
Recurrence of atrial fibrillation after cardioversion
Lead sponsor: University Hospital, Saarland
Sponsor class: OTHER
Collaborators: name: University Medical Center Groningen
name: Pfizer
First posted: 2008-03-31
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Atrial fibrillation recurrence after electrical cardioversion of atrial fibrillation
timeFrame: 8 weeks
Secondary outcomes:
measure: Sinus rhythm within eplerenone treatment before planned electrical cardioversion
timeFrame: 3 weeks
measure: Cardioversion success
timeFrame: at least one sinus beat
measure: Time to recurrence of atrial fibrillation
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Homburg/Saar
country: Germany
facility: Universitätsklinikum des Saarlandes, Klinik für Innere Medizin III
city: Groningen
country: Netherlands
facility: Rijksuniversiteit Groningen, Universitair Medisch Centrum
Study officials:
affiliation: Universitätsklinikum des Saarlandes, Klinik für Innere Medizin III
name: Michael Böhm, MD
role: PRINCIPAL_INVESTIGATOR
References: