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Stellate Ganglion Block as Novel Treatment for Heart Failure Patients

Stellate Ganglion Block as Novel Treatment for Heart Failure Patients

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06244056
Enrollment
108
Registered
2024-02-06
Start date
2024-02-05
Completion date
2025-01-01
Last updated
2024-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stellate Ganglion Block

Brief summary

Stellate Ganglion Block as Novel Treatment for Heart Failure Patients

Detailed description

Stellate Ganglion Block as Novel Treatment for Heart Failure Patients

Interventions

PROCEDUREStellate 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.

Sponsors

Mina sobhi said fam
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change of left ventricular ejection fraction (LVEF).3 monthChange of left ventricular ejection fraction (LVEF).
Change of NYHA classification.3 monthChange of NYHA classification.

Secondary

MeasureTime frameDescription
Change of 6 minutes walking test.3 monthChange of 6 minutes walking test.
Heart failure hospitalization.3 monthHeart failure hospitalization.
Vascular complications and safety issues.3 monthVascular complications and safety issues.
Cardiovascular death.3 monthCardiovascular death.

Countries

Egypt

Contacts

Primary ContactMina Fam, Resident
minassfam@yahoo.com01122035368
Backup ContactAly Tohamy, Lecturer
Ali.tohamy@gmail.comAli.tohamy@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026