Back to resultsEPLERAF-Study: Eplerenone in the Prevention of Atrial Fibrillation Recurrences After Cardioversion (EPLERAF)
Primary Purpose
Atrial Fibrillation
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Eplerenone
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Atrial Fibrillation focused on measuring atrial fibrillation, electrical cardioversion, prevention of atrial fibrillation recurrence, mineralocorticoid receptor blocker, eplerenone, Recurrence of atrial fibrillation after cardioversion
Eligibility 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
Sites / Locations
- Universitätsklinikum des Saarlandes, Klinik für Innere Medizin III
- Rijksuniversiteit Groningen, Universitair Medisch Centrum
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
Eplerenone treatment
Outcomes
Primary Outcome Measures
Atrial fibrillation recurrence after electrical cardioversion of atrial fibrillation
Secondary Outcome Measures
Sinus rhythm within eplerenone treatment before planned electrical cardioversion
Cardioversion success
Time to recurrence of atrial fibrillation
Full Information
NCT ID
NCT00647192
First Posted
March 26, 2008
Last Updated
February 9, 2012
Sponsor
University Hospital, Saarland
Collaborators
University Medical Center Groningen, Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00647192
Brief Title
EPLERAF-Study: Eplerenone in the Prevention of Atrial Fibrillation Recurrences After Cardioversion
Acronym
EPLERAF
Official Title
EPLERAF-Study: Eplerenone in the Prevention of Atrial Fibrillation Recurrences After Cardioversion
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Terminated
Why Stopped
Inclusion rate too low. Recruitment of further study centers too costly.
Study Start Date
March 2008 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Saarland
Collaborators
University Medical Center Groningen, Pfizer
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
atrial fibrillation, electrical cardioversion, prevention of atrial fibrillation recurrence, mineralocorticoid receptor blocker, eplerenone, Recurrence of atrial fibrillation after cardioversion
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Eplerenone treatment
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Eplerenone
Intervention Description
50 mg per day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
50 mg per day
Primary Outcome Measure Information:
Title
Atrial fibrillation recurrence after electrical cardioversion of atrial fibrillation
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Sinus rhythm within eplerenone treatment before planned electrical cardioversion
Time Frame
3 weeks
Title
Cardioversion success
Time Frame
at least one sinus beat
Title
Time to recurrence of atrial fibrillation
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Böhm, MD
Organizational Affiliation
Universitätsklinikum des Saarlandes, Klinik für Innere Medizin III
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätsklinikum des Saarlandes, Klinik für Innere Medizin III
City
Homburg/Saar
ZIP/Postal Code
66421
Country
Germany
Facility Name
Rijksuniversiteit Groningen, Universitair Medisch Centrum
City
Groningen
ZIP/Postal Code
NL-9700 RB
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
EPLERAF-Study: Eplerenone in the Prevention of Atrial Fibrillation Recurrences After Cardioversion
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