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

This study has been terminated.
(Inclusion rate too low. Recruitment of further study centers too costly.)
Sponsor:
Collaborators:
University Medical Centre Groningen
Pfizer
Information provided by (Responsible Party):
University Hospital, Saarland
ClinicalTrials.gov Identifier:
NCT00647192
First received: March 26, 2008
Last updated: February 9, 2012
Last verified: February 2012
History of Changes
  Purpose

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 Intervention Phase
Atrial Fibrillation
 Drug: Eplerenone
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: EPLERAF-Study: Eplerenone in the Prevention of Atrial Fibrillation Recurrences After Cardioversion

Resource links provided by NLM:

Drug Information available for: Eplerenone
U.S. FDA Resources

Further study details as provided by University Hospital, Saarland:

Primary Outcome Measures:
  • Atrial fibrillation recurrence after electrical cardioversion of atrial fibrillation [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sinus rhythm within eplerenone treatment before planned electrical cardioversion [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Cardioversion success [ Time Frame: at least one sinus beat ] [ Designated as safety issue: No ]
  • Time to recurrence of atrial fibrillation [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 38
Study Start Date: March 2008
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Eplerenone treatment
 Drug: Eplerenone
50 mg per day
Placebo Comparator: 2 Drug: Placebo
50 mg per day

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00647192

Locations
Germany
Universitätsklinikum des Saarlandes, Klinik für Innere Medizin III
Homburg/Saar, Germany, 66421
Netherlands
Rijksuniversiteit Groningen, Universitair Medisch Centrum
Groningen, Netherlands, NL-9700 RB
Sponsors and Collaborators
University Hospital, Saarland
University Medical Centre Groningen
Pfizer
Investigators
Principal Investigator: Michael Böhm, MD Universitätsklinikum des Saarlandes, Klinik für Innere Medizin III
  More Information

No publications provided

Responsible Party: University Hospital, Saarland
ClinicalTrials.gov Identifier: NCT00647192     History of Changes
Other Study ID Numbers: EPLERAF-01, Version 09_D, EudraCT number: 2007-002119-17
Study First Received: March 26, 2008
Last Updated: February 9, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital, Saarland:
atrial fibrillation
electrical cardioversion
prevention of atrial fibrillation recurrence
 mineralocorticoid receptor blocker
eplerenone
Recurrence of atrial fibrillation after cardioversion

Additional relevant MeSH terms:
Atrial Fibrillation
Recurrence
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Disease Attributes
 Eplerenone
Aldosterone Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013