Stellate Ganglion Block as Novel Treatment for Heart Failure Patients

Phase 2

Recruiting

• Conditions: Stellate Ganglion Block
• Interventions: Procedure: 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

Arm && Interventions

Group	Intervention	Description
Wide QRS complex heart failure patients	Stellate Ganglion Block	Wide QRS complex heart failure patients with optimal medical treatment who were non responders to CRT( retrospective and prospective) with stellate ganglion block.
: Narrow QRS complex Heart failure patients	Stellate Ganglion Block	: Narrow QRS complex Heart failure patients with optimal medical treatment with stellate ganglion block.

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