EPLERAF-Study: Eplerenone in the Prevention of Atrial Fibrillation Recurrences After Cardioversion
NCT00647192
ABOUT THIS STUDY
FOR MORE INFORMATION
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- 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.
- 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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Descriptive Information | ||||
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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 |
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Study Arms ICMJE |
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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 | 38 | |||
Original Estimated Enrollment ICMJE | 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:
Exclusion Criteria:
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Sex/Gender ICMJE |
| |||
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 |
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Investigators ICMJE |
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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 |