Atrial FibrillationPhase 2EPLERAFNCT00647192
EPLERAF-Study: Eplerenone in the Prevention of Atrial Fibrillation Recurrences After Cardioversion
A Phase 2 study testing Eplerenone in people with Atrial Fibrillation, run by University Hospital, Saarland at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Eplerenone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Mar 2008to Feb 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Germany1 site
Universitätsklinikum des Saarlandes, Klinik für Innere Medizin III
Homburg/Saar, 66421
Netherlands1 site
Rijksuniversiteit Groningen, Universitair Medisch Centrum
Groningen, NL-9700 RB
About this study
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.
- Conditions
- Atrial Fibrillation
- Being tested
- Eplerenone, Placebo
- Keywords
- atrial fibrillation, electrical cardioversion, prevention of atrial fibrillation recurrence, mineralocorticoid receptor blocker, eplerenone, Recurrence of atrial fibrillation after cardioversion
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EplerenoneDrug
50 mg per day
PlaceboDrug
50 mg per day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Eplerenone treatment Receives: Drug: Eplerenone |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atrial fibrillation recurrence after electrical cardioversion of atrial fibrillation
Measured: 8 weeks
Secondary outcomes (3)
Sinus rhythm within eplerenone treatment before planned electrical cardioversion
Measured: 3 weeks
Cardioversion success
Measured: at least one sinus beat
Time to recurrence of atrial fibrillation
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionFeb 2012
- Study completionFeb 2012
Why it stopped: Inclusion rate too low. Recruitment of further study centers too costly.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Saarland
- Sponsor type
- University, hospital or other
- Collaborators
- University Medical Center Groningen, Pfizer
- Responsible party
- Sponsor
- Investigators
- Michael Böhm, MD, Principal investigator, Universitätsklinikum des Saarlandes, Klinik für Innere Medizin III
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00647192
- Sponsor's protocol ID
- EPLERAF-01
- Other IDs
- Version 09_D, EudraCT number: 2007-002119-17
- Acronym
- EPLERAF
- Status last verified
- Feb 2012
- First submitted
- 26 Mar 2008
- Last updated
- 10 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EPLERAF-Study: Eplerenone in the Prevention of Atrial Fibrillation Recurrences After Cardioversion
- ClinicalTrials.gov ID
- NCT00647192
- Acronym / sponsor ID
- EPLERAF / EPLERAF-01
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, electrical cardioversion, prevention of atrial fibrillation recurrence, mineralocorticoid receptor blocker, eplerenone, Recurrence of atrial fibrillation after cardioversion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inclusion rate too low. Recruitment of further study centers too costly.
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University Hospital, SaarlandUniversity, hospital or other
- Collaborators
- University Medical Center Groningen, Pfizer
- Study start
- Mar 2008
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 31 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: EplerenoneEplerenone treatment |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eplerenone50 mg per day | Drug | 1 |
| Placebo50 mg per day | Drug | 2 |
Primary outcome
Atrial fibrillation recurrence after electrical cardioversion of atrial fibrillation
Time frame: 8 weeks
3 secondary outcomes
Sinus rhythm within eplerenone treatment before planned electrical cardioversion
Time frame: 3 weeks
Cardioversion success
Time frame: at least one sinus beat
Time to recurrence of atrial fibrillation
Time frame: 8 weeks
Results and safety
The study was stopped early (reason given: Inclusion rate too low. Recruitment of further study centers too costly.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2012.
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Böhm, MD principal investigator
Universitätsklinikum des Saarlandes, Klinik für Innere Medizin III
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Eplerenone in people with Atrial Fibrillation, run by University Hospital, Saarland at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Inclusion rate too low. Recruitment of further study centers too costly.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atrial fibrillation recurrence after electrical cardioversion of atrial fibrillation (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2012.