NCT01782677已完成不适用
Bilateral Surgical Resection of Carotid Bodies in Patients With Systolic Heart Failure
Noblewell2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2012年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Muscle sympathetic nerve activity
研究概览
简要总结
The primary aim of the study is to determine safety, tolerability and feasibility of bilateral carotid body resection in patients with systolic heart failure and peripheral chemoreceptor hypersensitivity. The secondary aim is to assess potential efficacy of bilateral carotid body resection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of heart failure class II-III according to NYHA within at least 6 months prior to inclusion
- •Stable clinical state within at least 4 weeks prior to inclusion
- •Subject >= 18 years old
- •Left ventricular ejection fraction ≤ 45% evaluated by transthoracic echocardiography (Simpson's method)
- •Carotid body present in computer cervical angiotomography
- •History of exacerbated peripheral chemoreceptor sensitivity determined as >0.6L/min/%SpO2
- •Able and willing to give written informed consent
排除标准
- •Unstable angina pectoris, coronary attack, coronary revascularization, exacerbation of heart-failure requiring hospitalization, clinically significant infection, surgery under general anesthesia within 3 months prior to inclusion
- •History of stroke, transient ischemic attack (TIA), or clinically significant chronic neurological disorder
- •History of heart transplant
- •Pregnancy or anticipation of pregnancy
- •Hemodialysis or peritoneal dialysis patients
- •Obstructive carotid atherosclerotic disease with >50% stenosis
- •COPD stage III and IV according to GOLD 2007
- •Unable to perform the spiroergometric assessment
- •Any significant anomaly in additional investigation which may increase the risk of study procedure
结局指标
主要结局
Muscle sympathetic nerve activity
时间窗: 4 weeks
Change from baseline in muscle sympathetic nerve activity at 4 weeks.
Peripheral chemosensitivity
时间窗: 4 weeks
Change from baseline in peripheral chemosensitivity measured as ventilatory response to hypoxia using transient inhalation of nitrogen at 4 weeks.
次要结局
- Heart function and morphology(8 weeks)
- Sleep pattern in PSG(8 weeks)
- Arrhythmia burden(8 weeks)
- Exercise tolerance(8 weeks)
- Quality of life(8 weeks)
- Serum concentration of NT-proBNP(8 weeks)
- Barosensitivity(8 weeks)
- Peripheral chemosensitivity(8 weeks)
- Muscle sympathetic nerve activity(8 weeks)
研究者
研究点 (2)
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