Stellate Ganglion Block as Novel Treatment for Heart Failure Patients

NCT ID: NCT06244056

Last Updated: 2024-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-05

Study Completion Date

2025-01-01

Brief Summary

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Stellate Ganglion Block as Novel Treatment for Heart Failure Patients

Detailed Description

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Stellate Ganglion Block as Novel Treatment for Heart Failure Patients

Conditions

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Stellate Ganglion Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Narrow QRS complex Heart failure patients

Narrow QRS complex Heart failure patients with optimal medical treatment.

Group Type NO_INTERVENTION

No interventions assigned to this group

: Narrow QRS complex Heart failure patients

: Narrow QRS complex Heart failure patients with optimal medical treatment with stellate ganglion block.

Group Type ACTIVE_COMPARATOR

Stellate Ganglion Block

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Stellate Ganglion Block

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mina sobhi said fam

OTHER

Sponsor Role lead

Responsible Party

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Mina sobhi said fam

resident doctor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Assiut University

Asyut, , Egypt

Site Status NOT_YET_RECRUITING

Assiut university

Asyut, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Mina Fam, Resident

Role: CONTACT

01122035368

Aly Tohamy, Lecturer

Role: CONTACT

Facility Contacts

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Mina Fam, Resident

Role: primary

+201122035368

Other Identifiers

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Stellate Ganglion Block 2023

Identifier Type: -

Identifier Source: org_study_id

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