NCT00647192

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at below P25 for phase_2 atrial-fibrillation

Timeline
Completed

Started Mar 2008

Longer than P75 for phase_2 atrial-fibrillation

Geographic Reach
2 countries

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

March 26, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 31, 2008

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

February 10, 2012

Status Verified

February 1, 2012

Enrollment Period

3.9 years

First QC Date

March 26, 2008

Last Update Submit

February 9, 2012

Conditions

Atrial Fibrillation

Keywords

atrial fibrillationelectrical cardioversionprevention of atrial fibrillation recurrencemineralocorticoid receptor blockereplerenoneRecurrence of atrial fibrillation after cardioversion

Outcome Measures

Primary Outcomes (1)

  • Atrial fibrillation recurrence after electrical cardioversion of atrial fibrillation

    8 weeks

Secondary Outcomes (3)

  • Sinus rhythm within eplerenone treatment before planned electrical cardioversion

    3 weeks

  • Cardioversion success

    at least one sinus beat

  • Time to recurrence of atrial fibrillation

    8 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Eplerenone treatment

Drug: Eplerenone

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

EplerenoneDRUG

50 mg per day

1
PlaceboDRUG

50 mg per day

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Universitätsklinikum des Saarlandes, Klinik für Innere Medizin III

Homburg/Saar, 66421, Germany

Location

Rijksuniversiteit Groningen, Universitair Medisch Centrum

Groningen, NL-9700 RB, Netherlands

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Eplerenone

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Michael Böhm, MD

    Universitätsklinikum des Saarlandes, Klinik für Innere Medizin III

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2008

First Posted

March 31, 2008

Study Start

March 1, 2008

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

February 10, 2012

Record last verified: 2012-02

Locations

NL(1)DE(1)