Stellate Ganglion Block as Novel Treatment for Heart Failure Patients

Stellate Ganglion Block Clinical Trial

Official title:

Stellate Ganglion Block as Novel Treatment for Heart Failure Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06244056
• Other study ID #: Stellate Ganglion Block 2023
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: February 5, 2024
• Est. completion date: January 1, 2025

Study information

• Verified date: February 2024
• Source: Assiut University
• Contact: Mina Fam, Resident
• Phone: 01122035368
• Email: minassfam[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Stellate Ganglion Block as Novel Treatment for Heart Failure Patients

Description:

Stellate Ganglion Block as Novel Treatment for Heart Failure Patients

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ganglion Cysts
• Heart Failure
• Stellate Ganglion Block

Intervention

Procedure:
• Stellate Ganglion Block
A stellate ganglion block is performed by a medical professional in a sterile setting. Firstly Position of patient: Semi-lateral decubitus position, with the neck turned contralateral. Using Probe of ultrasound: Linear 6-13 MHz to guide the needle to the stellate ganglion , The skin at the injection site is cleaned with an antiseptic solution to reduce the risk of infection. A local anesthetic is injected into the skin and deeper tissues to numb the area. Needle:25G 1.5 inch or 22G 3.5 inch is inserted through the skin and deeper tissues until it reaches the stellate ganglion.Once the needle is in the correct position, 3-5 mL of local anesthetic (0.25-0.5% bupivacaine) The procedure typically takes about 15-20 minutes.

Locations

Country	Name	City	State
Egypt	Assiut University	Assiut
Egypt	Assiut university	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Mina sobhi said fam

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of left ventricular ejection fraction (LVEF).	Change of left ventricular ejection fraction (LVEF).	3 month
Primary	Change of NYHA classification.	Change of NYHA classification.	3 month
Secondary	Change of 6 minutes walking test.	Change of 6 minutes walking test.	3 month
Secondary	Heart failure hospitalization.	Heart failure hospitalization.	3 month
Secondary	Vascular complications and safety issues.	Vascular complications and safety issues.	3 month
Secondary	Cardiovascular death.	Cardiovascular death.	3 month