NCT06244056招募中2 期
Stellate Ganglion Block as Novel Treatment for Heart Failure Patients
Mina sobhi said fam4 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2024年2月5日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 108
- 试验地点
- 4
- 主要终点
- Change of NYHA classification.
研究概览
简要总结
Stellate Ganglion Block as Novel Treatment for Heart Failure Patients
详细描述
Stellate Ganglion Block as Novel Treatment for Heart Failure Patients
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
- Triple (Participant, Care Provider, Investigator)
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
- •Age 18 : 70 years old.
- •NYHA Class III-IV Heart Failure.
- •Heart failure with a reduced ejection fraction (HFrEF) LVEF ≤ 40% calculated using 2D echocardiography and Biplane Simpson's .
- •Optimal tolerated Medical Therapy for Heart Failure.
排除标准
- •Active Malignancy.
- •Acute heart failure including pulmonary edema or cardiogenic shock.
- •Severe, life-threatening non-cardiac disease.
- •Pregnancy.
- •Localized infection.
- •Coagulopathy or anticoagulated patients.
- •Refused this procedure.
结局指标
主要结局
Change of NYHA classification.
时间窗: 3 month
Change of NYHA classification.
Change of left ventricular ejection fraction (LVEF).
时间窗: 3 month
Change of left ventricular ejection fraction (LVEF).
次要结局
- Change of 6 minutes walking test.(3 month)
- Heart failure hospitalization.(3 month)
- Vascular complications and safety issues.(3 month)
- Cardiovascular death.(3 month)
研究者
Mina sobhi said fam
resident doctor
Assiut University
研究点 (4)
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