Stellate Ganglion Block as Novel Treatment for Heart Failure Patients

Phase 2

Recruiting

• Conditions: Stellate Ganglion Block

• Registration Number: NCT06244056
• Lead Sponsor: Mina sobhi said fam

Brief Summary

Stellate Ganglion Block as Novel Treatment for Heart Failure Patients

Detailed Description

Stellate Ganglion Block as Novel Treatment for Heart Failure Patients

Study Timeline

• Study First Submitted: 2023-11-17
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-02
• Last Update Submitted: 2024-02-02
• Study Start: 2024-02-05
• Study First Posted: 2024-02-06
• Last Update Posted: 2024-02-06
• Primary Completion: 2025-01-01
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change of NYHA classification.	3 month	Change of NYHA classification.
Change of left ventricular ejection fraction (LVEF).	3 month	Change of left ventricular ejection fraction (LVEF).

Secondary Outcome Measures

Name	Time	Method
Change of 6 minutes walking test.	3 month	Change of 6 minutes walking test.
Heart failure hospitalization.	3 month	Heart failure hospitalization.
Vascular complications and safety issues.	3 month	Vascular complications and safety issues.
Cardiovascular death.	3 month	Cardiovascular death.

Trial Locations

Locations (2)

Assiut University; 🇪🇬 Assiut, Egypt

Assiut university; 🇪🇬 Assiut, Egypt