Atrial Fibrillation
Conditions
Keywords
atrial fibrillation, electrical cardioversion, prevention of atrial fibrillation recurrence, mineralocorticoid receptor blocker, eplerenone, Recurrence of atrial fibrillation 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.
Interventions
DRUGEplerenone
50 mg per day
DRUGPlacebo
50 mg per day
Sponsors
University Medical Center Groningen
Pfizer
University Hospital, Saarland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Atrial fibrillation recurrence after electrical cardioversion of atrial fibrillation | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Germany, Netherlands
Outcome results
None listed