EPLERAF-Study: Eplerenone in the Prevention of Atrial Fibrillation Recurrences After Cardioversion

Sponsor

University Hospital, Saarland (Other)

Overall Status

Terminated

CT.gov ID

NCT00647192

Collaborator

University Medical Center Groningen (Other), Pfizer (Industry)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Drug: Eplerenone Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

38 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Prevention

Official Title:

EPLERAF-Study: Eplerenone in the Prevention of Atrial Fibrillation Recurrences After Cardioversion

Study Start Date :

Mar 1, 2008

Actual Primary Completion Date :

Feb 1, 2012

Actual Study Completion Date :

Feb 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Eplerenone treatment	Drug: Eplerenone 50 mg per day
Placebo Comparator: 2	Drug: Placebo 50 mg per day

Arm

Intervention/Treatment

Active Comparator: 1

Eplerenone treatment

Drug: Eplerenone

50 mg per day

Placebo Comparator: 2

Drug: Placebo

50 mg per day

Outcome Measures

Primary Outcome Measures

Atrial fibrillation recurrence after electrical cardioversion of atrial fibrillation [8 weeks]

Secondary Outcome Measures

Sinus rhythm within eplerenone treatment before planned electrical cardioversion [3 weeks]
Cardioversion success [at least one sinus beat]
Time to recurrence of atrial fibrillation [8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universitätsklinikum des Saarlandes, Klinik für Innere Medizin III	Homburg/Saar		Germany	66421
2	Rijksuniversiteit Groningen, Universitair Medisch Centrum	Groningen		Netherlands	NL-9700 RB