Stellate Ganglion Block as Novel Treatment for Heart Failure Patients

February 2, 2024 updated by: Mina sobhi said fam
Stellate Ganglion Block as Novel Treatment for Heart Failure Patients

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Stellate Ganglion Block as Novel Treatment for Heart Failure Patients

Study Type

Interventional

Enrollment (Estimated)

108

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
      • Assiut, Egypt, 71515
        • Recruiting
        • Assiut University
        • Contact:
      • Assiut, Egypt, 71515
        • Not yet recruiting
        • Assiut University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Narrow QRS complex Heart failure patients
Narrow QRS complex Heart failure patients with optimal medical treatment.
Active Comparator: : Narrow QRS complex Heart failure patients
: Narrow QRS complex Heart failure patients with optimal medical treatment with stellate ganglion block.
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.
Active Comparator: Wide QRS complex heart failure patients
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of left ventricular ejection fraction (LVEF).
Time Frame: 3 month
Change of left ventricular ejection fraction (LVEF).
3 month
Change of NYHA classification.
Time Frame: 3 month
Change of NYHA classification.
3 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of 6 minutes walking test.
Time Frame: 3 month
Change of 6 minutes walking test.
3 month
Heart failure hospitalization.
Time Frame: 3 month
Heart failure hospitalization.
3 month
Vascular complications and safety issues.
Time Frame: 3 month
Vascular complications and safety issues.
3 month
Cardiovascular death.
Time Frame: 3 month
Cardiovascular death.
3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mina sobhi said fam

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 5, 2024

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

November 17, 2023

First Submitted That Met QC Criteria

February 2, 2024

First Posted (Estimated)

February 6, 2024

Study Record Updates

Last Update Posted (Estimated)

February 6, 2024

Last Update Submitted That Met QC Criteria

February 2, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Stellate Ganglion Block 2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stellate Ganglion Block

Clinical Trials on Stellate Ganglion Block

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Israel

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe