EUCTR2004-000957-47-SI进行中（未招募）1 期
Comparison of Bisoprolol and Carvedilol in elderly patients withheart failure. A randomised doubleblind multicenter trial - CIBIS-ELD
Charité0 个研究点目标入组 1,040 人开始时间: 2007年11月8日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,040
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
- •Age = 65 years
- •Current diagnosis of HF with symptoms consistent with NYHA II or above
- •Left ventricular ejection fraction (LVEF) = 45 % (documented by echocardiography, levocardiography or magnetic resonance imaging (MRI)) and/ or echocardiographic parameters of diastolic dysfunction Stage = I
- •Chronic heart failure was stable for the previous two weeks
- •Written informed consent was obtained
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •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
- •A previously prescribed basic therapy consisting of ACE inhibitors (or angiotensin receptor antagonists or vasodilators), diuretics and, where applicable, aldosterone antagonists and digoxin was changed within the last two weeks before the study
- •Intake of beta-blockers for longer than 14 days within the last three months in a dose which is more than ¼ of the recommended daily intake.
- •Other systemically administered beta-blockers except for the study medication during participation (including sotalol)
- •Acute or de-compensated HF
- •Cardiogenic shock
- •Acute pulmonary embolism
- •Obstructive or restrictive cardiomyopathy
- •Severe pulmonary dysfunction or severe asthma
- •Uncontrolled hypertension (systolic BP > 190 mmHg or diastolic BP >110 mmHg)
- •Endocarditis and myocarditis
- •History of heart transplant surgery within two months prior to the study or planned
- •Uncontrolled hypo – or hyperthyroidism
- •Known alcohol or drug abuse
- •Known significant diseases or clinically relevant abnormal lab results which are deemed by the investigator to have a disadvantageous effect on either the patients’ prognosis or the possibility of their participation
- •Participation in another clinical study within the last 30 days
- •Legal incapacity or reduced legal capacity
- •Known hypersensitivity to bisoprolol or carvedilol
- •Advanced peripheral vascular disease and/ or Raynaud’s disease
- •Hypotension (systolic < 90 mmHg in supine position at inclusion)
- •Known predisposition to orthostatic hypotension
- •Bradycardia with less than 55 bpm prior to commencement of the therapy
- •First or second degree sinoatrial or atrioventricular block (without pacemaker) or known sick sinus syndrome
- •Strict fasting
- •Current desensitisation therapy
- •Known pheochromocytoma or clinical suspicion for this disease (-)
- •Clinically relevant liver function abnormalities
- •Intake or current need for the intake of any of the contraindicated concomitant medication
- •Contraindications to beta-blocker therapy
- •Inotropic substances with the exception of digoxin
- •Ergotamine derivates
- •Calcium-channel-blockers of the phenylalkylamine type
- •Rifampicin
- •Antiarrhythmic medications except amiodarone
- •Monoamine oxidase inhibitors (except MAO-B inhibitors)
- •a1-Antagonists or a2-Agonists
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