Recurrence of atrial fibrillation after electrical cardioversion of persistent atrial fibrillation. MedDRA version: 9.1 Level: LLT Classification code 10066582 Term: Recurrent atrial fibrillation
Conditions
Interventions
Trade Name: Inspra
Product Name: Inspra
Product Code: 53175.00.00
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: EPLERENONE
CAS Number: 107724209
Concentration unit: mg milligram(s)
Conc
Sponsors
Universität des Saarlandes
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Persistent atrial fibrillation (AF), AF persistence for > 7 days but =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: a) Hemodynamic instability or symptoms not allowing cardioversion to be delayed for 3 weeks b) Myocardial infarction within the last 3 months c) Heart failure NYHA class III – IV d) 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). e) Pre-treatment with an aldosterone antagonist or other potassium sparing diuretics f) Instable angina pectoris g) Use of Digitalis h) Use of class I or class III antiarrhythmic drugs (must be stopped at least 5 half-life before) i) Contraindication or hypersensitivity to ß-blockers j) Open heart surgery within the last 3 months k) Pregnancy l) Acute and reversible illnesses m) Acute and chronic infection n) Alcohol or drug abuse or a severe progressive extracardiac disease o) Untreated manifest and latent hyper- or hypothyreodism or 5 mmol/l u) Patients unlikely to comply with the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate whether Eplerenone reduces atrial fibrillation (AF) recurrences within the first 8 weeks after electrical cardioversion of persistent AF.;Secondary Objective: - To investigate whether Eplerenone delays atrial fibrillation (AF) recurrences within the first 8 weeks after electrical cardioversion of persistent AF. - To investigate whether Eplerenone facilitates electrical or spontaneous cardioversion of persistent AF.;Primary end point(s): AF recurrence (documented, symptomatic or asymptomatic AF episodes > 30 seconds within the first 8 weeks after electrical cardioversion) | — |
Countries
Germany
Outcome results
None listed