【ChiCTR-ONRC-10001034】心臟肌肉收縮力調節對己接受同步治療但沒有預期改善的心臟衰竭病人的治療效果的研究

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基本信息

登记号

ChiCTR-ONRC-10001034

试验状态

暂停或中断

药物名称

药物类型

规范名称

首次公示信息日的期

2010-07-06

临床申请受理号

靶点

适应症

Heart Failure

试验通俗题目

心臟肌肉收縮力調節對己接受同步治療但沒有預期改善的心臟衰竭病人的治療效果的研究

试验专业题目

心臟肌肉收縮力調節對己接受同步治療但沒有預期改善的心臟衰竭病人的治療效果的研究

申办单位信息

申请人联系人

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申请人名称

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联系人邮箱

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联系人邮编

联系人通讯地址

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临床试验信息

试验目的

心臟肌肉收縮力調節對己接受同步治療但沒有預期改善的心臟衰竭病人的治療效果的研究

试验分类

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试验类型

非随机对照试验

试验分期

Ⅰ期

随机化

盲法

试验项目经费来源

Impulse Dynamics

试验范围

目标入组人数

40;0

实际入组人数

第一例入组时间

2010-02-09

试验终止时间

2013-02-10

是否属于一致性

入选标准

1. Heart failure (HF) patients remain in New York Heart Association Class III or IV who have received cardiac resynchronization in form of biventricular pacemaker or biventricular cardiovertor-defibrillator devices; 2. Have been classified as non-responder of CRT as defined by absence of reduction of left ventricular end-systolic volume reduction of less than 15% after 3months of therapy; 3. Have been treated with optimal anti-HF medications with doses not varying by more than 50% for a minimum of 4 weeks, e.g. diuretics, Angiotensin Converting Enzyme Inhibitors or Angiotensin Receptor Blocker, -blockers, etc.；

排除标准

1. Subjects with severe symptomatic heart failure who would qualify for heart transplant, or who have recently (within 2 weeks) been hospitalized and treated with intravenous inotropic agents or intravenous diuretics or whose baseline VO2,max is known to be <10 ml O2/min/kg; 2. Subjects who have a potentially correctible cause of heart failure, such as valvular heart disease or congenital heart disease; 3. Subjects who have clinically significant angina pectoris, consisting of angina during daily life (i.e., Canadian Cardiovascular Society Angina score of II or more), an episode of unstable angina within 30 days of enrollment, or angina and/or ECG changes during exercise testing performed during baseline evaluation; 4. Subjects without an ICD who have a documented history of sustained VT, or who have an indication for an ICD and are not scheduled for ICD implantation at the time of OPTIMIZER III implantation; 5. Subjects who have an ICD who have had appropriate ICD firing during the past one month; 6. Subjects who have a clinically significant amount of ambient ectopy, defined as more than 8,900 PVCs per 24 hours on baseline Holter monitoring; 7. Subjects who have chronic atrial fibrillation or chronic atrial flutter; 8. Subjects whose exercise tolerance is limited by a condition other than heart failure (e.g., angina, COPD, peripheral vascular disease, orthopedic or rheumatologic conditions); 9. Subjects who are unable to participate in a 6-minute walk; 10. Subjects who are scheduled for a CABG or a PTCA procedure, or who have undergone a CABG procedure within three months or a PTCA procedure within one month of enrollment; 11. Subjects who have had a myocardial infarction within three months of enrollment; 12. Subjects who have mechanical tricuspid or aortic valves; 13. Subjects who have a prior heart transplant; 14. Subjects who are participating in another experimental protocol; 15. Subjects who are unable to provide informed consent.；

研究者信息

研究负责人姓名

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试验机构

Impulse Dynamics

研究负责人电话

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研究负责人邮编

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