EUCTR2010-018976-25-BE进行中（未招募）不适用
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
sanofi-aventis Belgium0 个研究点开始时间: 2010年6月10日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •Criteria stated in the Summary of Product Characteristics
- •------------------------------------------------------------------------
- •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
- •--------------------
- •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
- •-------------------------------------------
- •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
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