E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Recurrence of atrial fibrillation after electrical cardioversion of persistent atrial fibrillation. |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10066582 |
E.1.2 | Term | Recurrent atrial fibrillation |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To investigate whether Eplerenone reduces atrial fibrillation (AF) recurrences within the first 8 weeks after electrical cardioversion of persistent AF. |
|
E.2.2 | Secondary objectives of the trial |
- 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. |
|
E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Substudie: Labormarker des kardialen Remodelings. 06.03.2007; Version-01 |
|
E.3 | Principal 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. |
|
E.4 | Principal 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 < 3 months peripheral euthyrodidism (normal fT3) p) Moderate to severe renal insufficiency (Creatinine clearance less than 50 ml/min) q) Patients with liver cirrhosis (Child-Pugh class C) r) Co-administration of strong CYP3A4 inhibitors (e.g. Itrakonazol, Ketokonazol, Ritonavir, Nelfinavir, Klaritromycin, Telitromycin and Nephazodon) s) Hypersensitivity against Eplerenone and/or one of the other components of the tablet (see Fachinformation) t) Serum potassium > 5 mmol/l u) Patients unlikely to comply with the protocol
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
AF recurrence (documented, symptomatic or asymptomatic AF episodes > 30 seconds within the first 8 weeks after electrical cardioversion) |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 2 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The study is finished after the end of the 8-week follow-up of the last subject undergoing the trial. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |