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

February 9, 2012 updated by: University Hospital, Saarland
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Homburg/Saar, Germany, 66421
        • Universitätsklinikum des Saarlandes, Klinik für Innere Medizin III
  • Netherlands
      • Groningen, Netherlands, NL-9700 RB
        • Rijksuniversiteit Groningen, Universitair Medisch Centrum

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 2
Drug: Placebo
50 mg per day
ACTIVE_COMPARATOR: 1
Eplerenone treatment
Drug: Eplerenone
50 mg per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Atrial fibrillation recurrence after electrical cardioversion of atrial fibrillation
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Sinus rhythm within eplerenone treatment before planned electrical cardioversion
Time Frame: 3 weeks
3 weeks
Cardioversion success
Time Frame: at least one sinus beat
at least one sinus beat
Time to recurrence of atrial fibrillation
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Saarland

Collaborators

Pfizer
University Medical Center Groningen

Investigators

  • Principal Investigator: Michael Böhm, MD, Universitätsklinikum des Saarlandes, Klinik für Innere Medizin III

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (ACTUAL)

February 1, 2012

Study Completion (ACTUAL)

February 1, 2012

Study Registration Dates

First Submitted

March 26, 2008

First Submitted That Met QC Criteria

March 28, 2008

First Posted (ESTIMATE)

March 31, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

February 10, 2012

Last Update Submitted That Met QC Criteria

February 9, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPLERAF-01
  • Version 09_D
  • EudraCT number: 2007-002119-17

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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