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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00647192
• Date of registration: 26/03/2008
• Prospective Registration: No
• Primary sponsor: University Hospital, Saarland
• Public title: EPLERAF-Study: Eplerenone in the Prevention of Atrial Fibrillation Recurrences After Cardioversion EPLERAF
• Scientific title: EPLERAF-Study: Eplerenone in the Prevention of Atrial Fibrillation Recurrences After Cardioversion
• Date of first enrolment: March 2008
• Target sample size: 38
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00647192
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
• Phase: Phase 2

Countries of recruitment

Germany, Netherlands

Contacts

• Name: Michael Böhm, MD
• Affiliation: Universitätsklinikum des Saarlandes, Klinik für Innere Medizin III

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Atrial Fibrillation

Intervention(s)

Drug: Eplerenone

Drug: Placebo

Primary Outcome(s)

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

Secondary Outcome(s)

Time to recurrence of atrial fibrillation [Time Frame: 8 weeks]

Cardioversion success [Time Frame: at least one sinus beat]

Sinus rhythm within eplerenone treatment before planned electrical cardioversion [Time Frame: 3 weeks]

Secondary ID(s)

Version 09_D

EPLERAF-01

EudraCT number: 2007-002119-17

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Pfizer

University Medical Centre Groningen