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临床试验/NCT06244056
NCT06244056招募中2 期

Stellate Ganglion Block as Novel Treatment for Heart Failure Patients

Mina sobhi said fam2 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
干预措施

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
2
主要终点
Change of left ventricular ejection fraction (LVEF).

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.

研究组 & 干预措施

Narrow QRS complex Heart failure patients

No Intervention

Narrow QRS complex Heart failure patients with optimal medical treatment.

: Narrow QRS complex Heart failure patients

Active Comparator

: Narrow QRS complex Heart failure patients with optimal medical treatment with stellate ganglion block.

干预措施: Stellate Ganglion Block (Procedure)

Wide QRS complex heart failure patients

Active Comparator

Wide QRS complex heart failure patients with optimal medical treatment who were non responders to CRT( retrospective and prospective) with stellate ganglion block.

干预措施: Stellate Ganglion Block (Procedure)

结局指标

主要结局

Change of left ventricular ejection fraction (LVEF).

时间窗: 3 month

Change of left ventricular ejection fraction (LVEF).

Change of NYHA classification.

时间窗: 3 month

Change of NYHA classification.

次要结局

  • Vascular complications and safety issues.(3 month)
  • Cardiovascular death.(3 month)
  • Change of 6 minutes walking test.(3 month)
  • Heart failure hospitalization.(3 month)

研究者

发起方
Mina sobhi said fam
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mina sobhi said fam

resident doctor

Assiut University

研究点 (2)

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