Stellate Ganglion Block as Novel Treatment for Heart Failure Patients

NCT06244056 | Recruiting Phase 2 FDA Drug

• 1 other identifier: Stellate Ganglion Block 2023
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 2

Brief Summary

Stellate Ganglion Block as Novel Treatment for Heart Failure Patients

Conditions

Stellate Ganglion Block

Outcome Measures

Primary Outcomes (2)

• Change of left ventricular ejection fraction (LVEF).

  Change of left ventricular ejection fraction (LVEF).

  3 month

• Change of NYHA classification.

  Change of NYHA classification.

  3 month

Secondary Outcomes (4)

• Change of 6 minutes walking test.

  3 month

• Heart failure hospitalization.

  3 month

• Vascular complications and safety issues.

  3 month

• Cardiovascular death.

  3 month

Study Arms (3)

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.

Procedure: Stellate Ganglion Block

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.

Procedure: Stellate Ganglion Block

Interventions

Stellate Ganglion Block PROCEDURE

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.

: Narrow QRS complex Heart failure patients; Wide QRS complex heart failure patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mina sobhi said fam: lead

Study Sites (2)

Assiut University

Asyut, 71515, Egypt

NOT YET RECRUITING

Assiut university

Asyut, 71515, Egypt

RECRUITING

Central Study Contacts

Mina Fam, Resident

CONTACT

01122035368; minassfam@yahoo.com

Aly Tohamy, Lecturer

CONTACT

Ali.tohamy@gmail.com; Ali.tohamy@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: resident doctor

Model Details: 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.

Study Record Dates

• First Submitted: November 17, 2023
• First Posted: February 6, 2024
• Study Start: February 5, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: February 6, 2024

Record last verified: 2024-02

Locations

EG (2)