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

• Status: Terminated
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Saarland
• Collaborators: Pfizer; University Medical Center Groningen
• Treatments: Eplerenone; Spironolactone

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