ChiCTR-ONRC-10001036暂停或中断1 期
對患有心臟衰竭並接受心肌收縮力調節治療的病人，利用多維立體超聲波影像技術，評估其心臟功能改變的研究
RGC funding for the study1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2010年3月1日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 暂停或中断
- 发起方
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
對患有心臟衰竭並接受心肌收縮力調節治療的病人，利用多維立體超聲波影像技術，評估其心臟功能改變
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 18（—）
- 性别
- All
入选标准
- •. Heart failure (HF) patients with left ventricular ejection fraction less than or equal to 35% by echocardiography and New York Heart Association Class III or IV 2). 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, β-blockers, etc. 3). QRS duration < 130ms or if QRS >130ms, deemed not a candidate of cardiac resynchronization therapy by in-charge physicians 4). If clinically indicated, patient has automatic implantable cardiac defibrillator (ICD) and/or cardiac pacemaker; if patient has a clinical indication for such device(s) but is not already implanted, patient may be enrolled if simultaneous implantation of the appropriate device is scheduled
排除标准
- •. Subjects with severe symptomatic HF who would qualify for heart transplant, who have recently (within 3 months) been treated with intravenous inotropic agents or whose baseline VO2,max is known to be <11 ml/kg/min
- •. Subjects who have a potentially correctible cause of HF, 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 who have been hospitalized for HF which required the use of intravenous diuretics or inotropic support within two weeks of enrollment.
- •. Subjects without an implantable cardioverter defibrillator (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 CCM.
- •. 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 premature ventricular contractions per 24 hours on baseline Holter monitoring (which reduce significantly reducing the amount of CCM delivery).
- •. Subjects who have chronic atrial fibrillation or chronic atrial flutter.
- •. Subjects whose exercise tolerance is limited by a condition other than HF (e.g., angina, chronic obstructive pulmonary disease, peripheral vascular disease, orthopedic or rheumatologic conditions).
- •. Subjects who are unable to participate in a 6-minute hall walk or a cardiopulmonary stress test.
- •. Subjects who are scheduled for a coronary revascularization (CABG or PCI) procedure, or who have undergone a CABG procedure within three months or a PCI procedure within one month of enrollment.
- •. Subjects who have a biventricular pacemaker or whose primary care physician(s) believes a biventricular pacemaker is indicated.
- •. 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 have a previously implanted ICD which employs unipolar or integrated bipolar sensing
- •. Subjects who are participating in another experimental protocol.
- •. Subjects who are unable to provide informed consent.
研究组 & 干预措施
One group
Echocardiography assesses the Changes in Cardiac Function of heart failure by Cardiac Contractility Modulation for 4 years
0
Patient fulfilled into the study criteria will be enrolled. Baseline testing included echocardiography with RT3DE and TDI, Minnesota Living with Heart Failure Questionnaire (MLWHFQ), 6-minute hall walk test (6MHW), maximal oxygen consumption test on treadmill test and 24-hour Holter monitor.
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
1 期
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Heart FailureChiCTR-ONRC-10001034Impulse Dynamics40
Unknown
不适用
心力衰竭註冊研究：近 10 年治療和結果回顧Heart FailureChiCTR-OO-14004662Division funding5,000
Unknown
不适用
数字疗法在心衰患者全周期康复中可行性和有效性研究ChiCTR2200056020四川大学华西医院106
Unknown
不适用
研究慢性心臟衰竭健康教育計劃是否能有效改善長者自我照顧心臟衰竭的能力Chronic Heart FailureChiCTR-IOR-16008254HMRF236
招募中
Unknown
三维斑点追踪超声成像评估糖尿病对心力衰竭患者心功能的影响及预后研究心力衰竭ChiCTR2100047487国家自然科学基金(No.81922033)；国家重点研发项目(No.2018YFC0114600)300