ChiCTR-TRC-12002577暂停或中断不适用
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
Impulse Dynamics1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2005年7月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 暂停或中断
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- CCM will improve clinical and echocardiographic outcomes of the patient in CRT non-responders.
研究概览
简要总结
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
研究设计
- 研究类型
- 观察性研究
- 主要目的
- 非随机对照试验
入排标准
- 年龄范围
- 18 至 98（—）
- 性别
- All
入选标准
- •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.
- •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.
- •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
- •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;
- •Subjects who have a potentially correctible cause of heart failure, such as valvular heart disease or congenital heart disease;
- •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;
- •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;
- •Subjects who have an ICD who have had appropriate ICD firing during the past one month;
- •Subjects who have a clinically significant amount of ambient ectopy, defined as more than 8,900 PVCs per 24 hours on baseline Holter monitoring;
- •Subjects who have chronic atrial fibrillation or chronic atrial flutter;
- •Subjects whose exercise tolerance is limited by a condition other than heart failure (e.g., angina, COPD, peripheral vascular disease, orthopedic or rheumatologic conditions);
- •Subjects who are unable to participate in a 6-minute walk;
- •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;
- •Subjects who have had a myocardial infarction within three months of enrollment;
- •Subjects who have mechanical tricuspid or aortic valves;
- •Subjects who have a prior heart transplant;
- •Subjects who are participating in another experimental protocol;
- •Subjects who are unable to provide informed consent.
研究组 & 干预措施
Two groups
An OPTIMIZER System will be implanted and patients will be evaluated at the following pre-determined time-points: 1 week, 3 months, 6 months and 12 months (Appendix I).
(to be continued)
After implantation of the Optimizer System, the CRT device will remain active; thus patients will simultaneously receive CRT and CCM treatment.
结局指标
主要结局
CCM will improve clinical and echocardiographic outcomes of the patient in CRT non-responders.
次要结局
未报告次要终点
研究者
研究点 (1)
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