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Trial record 34 of 112 for:    EPLERENONE

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00647192
Recruitment Status : Terminated (Inclusion rate too low. Recruitment of further study centers too costly.)
First Posted : March 31, 2008
Last Update Posted : February 10, 2012
University Medical Center Groningen
Information provided by (Responsible Party):
University Hospital, Saarland

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

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Study Type : Interventional  (Clinical Trial)
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 : March 2008
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Eplerenone

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

Placebo Comparator: 2 Drug: Placebo
50 mg per day

Primary Outcome Measures :
  1. Atrial fibrillation recurrence after electrical cardioversion of atrial fibrillation [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Sinus rhythm within eplerenone treatment before planned electrical cardioversion [ Time Frame: 3 weeks ]
  2. Cardioversion success [ Time Frame: at least one sinus beat ]
  3. Time to recurrence of atrial fibrillation [ Time Frame: 8 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00647192

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

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Responsible Party: University Hospital, Saarland Identifier: NCT00647192     History of Changes
Other Study ID Numbers: EPLERAF-01
Version 09_D
EudraCT number: 2007-002119-17
First Posted: March 31, 2008    Key Record Dates
Last Update Posted: February 10, 2012
Last Verified: February 2012
Keywords provided by University Hospital, Saarland:
atrial fibrillation
electrical cardioversion
prevention of atrial fibrillation recurrence
mineralocorticoid receptor blocker
Recurrence of atrial fibrillation after cardioversion
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Disease Attributes
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Natriuretic Agents
Antihypertensive Agents