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

Atrial Fibrillation Clinical Trial

— EPLERAF  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00647192
• Other study ID #: EPLERAF-01
• Secondary ID: Version 09_DEudr
• Status: Terminated
• Phase: Phase 2
• First received: March 26, 2008
• Last updated: February 9, 2012
• Start date: March 2008
• Est. completion date: February 2012

Study information

• Verified date: February 2012
• Source: University Hospital, Saarland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 38
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atrial Fibrillation
• Recurrence

Intervention

Drug:
• Eplerenone
50 mg per day
• Placebo
50 mg per day

Locations

Country	Name	City	State
Germany	Universitätsklinikum des Saarlandes, Klinik für Innere Medizin III	Homburg/Saar
Netherlands	Rijksuniversiteit Groningen, Universitair Medisch Centrum	Groningen

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Saarland	Pfizer, University Medical Center Groningen

Countries where clinical trial is conducted

Germany,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Atrial fibrillation recurrence after electrical cardioversion of atrial fibrillation		8 weeks	No
Secondary	Sinus rhythm within eplerenone treatment before planned electrical cardioversion		3 weeks	No
Secondary	Cardioversion success		at least one sinus beat	No
Secondary	Time to recurrence of atrial fibrillation		8 weeks	No