NCT01224899已完成1 期
Left Cervico-Thoracic Sympathetic Blockade by Clipping in Systolic Heart Failure: A Randomised Controlled Trial
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Perioperative mortality and morbidity
研究概览
简要总结
The investigators sought to evaluate the feasibility and safety of surgical sympathetic blockade in systolic heart failure patients and secondary to assess its cardiovascular consequences.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chronic heart failure (at least 1 month of symptoms onset)
- •NYHA functional class II or III
- •LV ejection fraction 40% or lower
- •resting heart rate higher than 65 bpm
- •either maximum beta-blocker therapy according to guidelines or no beta-blocker use for intolerance.
排除标准
- •NYHA functional class I or IV
- •cardiogenic shock
- •resting heart rate ≤ 65 bpm
- •systolic blood pressure < 90 mmHg
- •sustained ventricular tachycardia
- •eligibility to other surgical procedures
- •procedure-limiting comorbidity
- •presence of ICD or pacemaker
- •valvar, chagasic or congenital cardiomyopathy
- •age > 70 years
- •patient refusal
- •contra-indication to videothoracoscopy
- •decompensated thyroid disease
- •atrial fibrillation or flutter
- •active infection
结局指标
主要结局
Perioperative mortality and morbidity
时间窗: 30 days after operation
Study interruption criteria: * death attributable to surgical procedure; * cardiogenic shock attributable to surgical procedure; * worsening of heart failure symptoms attributable to surgical procedure; * Horner's syndrome * hypotension or bradiarrhythmia attributable to surgical procedure
次要结局
- Cardiovascular effects(6 months)
研究者
研究点 (2)
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