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

NCT00647192

Last updated date
Study Location
Universitätsklinikum des Saarlandes, Klinik für Innere Medizin III
Homburg/Saar, , 66421, Germany
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Atrial Fibrillation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
Descriptive Information
Brief Title  ICMJE EPLERAF-Study: Eplerenone in the Prevention of Atrial Fibrillation Recurrences After Cardioversion
Official Title  ICMJE EPLERAF-Study: Eplerenone in the Prevention of Atrial Fibrillation Recurrences After Cardioversion
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Atrial Fibrillation
Intervention  ICMJE
  • Drug: Eplerenone
    50 mg per day
  • Drug: Placebo
    50 mg per day
Study Arms  ICMJE
  • Active Comparator: 1
    Eplerenone treatment
    Intervention: Drug: Eplerenone
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 9, 2012)
38
Original Estimated Enrollment  ICMJE
 (submitted: March 28, 2008)
220
Actual Study Completion Date  ICMJE February 2012
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00647192
Other Study ID Numbers  ICMJE EPLERAF-01
Version 09_D
EudraCT number: 2007-002119-17
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Saarland
Study Sponsor  ICMJE University Hospital, Saarland
Collaborators  ICMJE
  • University Medical Center Groningen
  • Pfizer
Investigators  ICMJE
Principal Investigator:Michael Böhm, MDUniversitätsklinikum des Saarlandes, Klinik für Innere Medizin III
PRS Account University Hospital, Saarland
Verification Date February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP