An open label non-controlled trial to evaluate the effect of dronedarone (Multaq® 400 mg BID) on the quality of life in patiënts with a history of, or current non-permanent atrial fibrillation (AF) - HEMERA

• Conditions: on permanent Atrial fibrillation; MedDRA version: 12.1Level: LLTClassification code 10003658Term: Atrial fibrillation

• Registration Number: EUCTR2010-018976-25-BE
• Lead Sponsor: sanofi-aventis Belgium

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-10
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Clinically stable patients with a history of, or current, symptomatic non-permanent Atrial Fibrillation (AF) in whom anti-arrhythmic treatment is indicated
• Patients able to understand the patient information leaflet and sign the Informed Consent form for this study protocol
• Patients aged = 18 years
• Documented AF within the last 6 months prior to inclusion or at the time of inclusion
• Documented sinus rhythm within the last 6 months prior to inclusion or at the time of inclusion

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Criteria stated in the Summary of Product Characteristics
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• Hypersensitivity to the active substance or to any of the excipients
• Second- or third-degree atrio-ventricular block or sick sinus syndrome (except when used in conjunction with a functioning pacemaker)
• Bradycardia < 50 beats per minute (bpm)
• Patients in unstable hemodynamic conditions including patients with symptoms of heart failure at rest or with minimal exertion (corresponding to NYHA class IV and unstable class III patients)
• Co-administration with potent cytochrome P450 (CYP) 3A4 inhibitors, such as ketoconazole, itraconazole, voriconazole, posaconazole, telithromycin, clarithromycin, nefazodone, and ritonavir
• Usage of medicinal products inducing torsade de pointes such as phenothiazines, cisapride, bepridil, tricyclic antidepressants, terfenadine, and certain oral macrolides, class I and III anti-arrhythmics
• QTc Bazett interval = 500 milliseconds
• Severe hepatic impairment
• Severe renal impairment (CrCl < 30 ml/min)
• Left Ventricular Ejection Fraction (LVEF) < 35%
• Stable patients with recent (1 to 3 months) NYHA class III heart failure
• Electrolytes imbalance; hypokalemia, serum potassium (< 3.5 mmol/l or > 5.5 mmol/l), or magnesium imbalance must be corrected before inclusion
• Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose mal-absorption
• Treatment with other class I or III anti-arrhythmic drugs which cannot be discontinued
• Pregnancy
• Breastfeeding women

General Criteria
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• Clinically relevant gastro-intestinal, psychiatric, or neurological disease
• Women of childbearing potential without adequate birth control (e.g. oral contraception or intra-uterine device [IUD]), not menopaused, not sterile, or not hysterectomized
• Participation in the preceding 2 months or current participation in another clinical trial with an investigational (under development) drug, or with an investigational device
• Inability to follow the protocol requirements
• Patient unable or unwilling to complete the Quality of Life questionnaires
• Patient unable or unwilling to participate in the Holter monitoring procedure
• Any non-cardiovascular illness or disorder that could preclude participation or severely limit survival

Criteria linked to cardiac condition
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• Patients with asymptomatic Atrial Fibrillation
• Patients unwilling to start with or change anti-arrhythmic therapy
• Patients already treated with dronedarone during the preceding 6 months
• Planned major non-cardiac or cardiac surgery, or procedures including surgery for valvular heart disease, coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI), or on urgent cardiac transplantation list
• Documented AF episode motivating inclusion in the study after an acute condition known to cause AF (e.g. alcohol intake, thyrotoxicosis, acute infection, pericarditis, pulmonary embolism, cardiac surgery)
•Patients known to have chronic AF defined as permanent AF for more than 6 months
• Ablated patients
• Unstable angina pectoris (ischemic symptoms during the last 7 days), or recent myocardial infarction (< 6 weeks)
• First-degree family history of sudden cardiac death below age of 50 years in the absence of coronary heart disease
• Ongoing potentially dangerous symptoms when in AF, such as angina pe

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified