Stellate Ganglion BlockPhase 2/3NCT06244056
Stellate Ganglion Block as Novel Treatment for Heart Failure Patients
A Phase 2/3 study testing Stellate Ganglion Block in people with Stellate Ganglion Block, run by Mina sobhi said fam at 2 sites in Egypt.
Trial summary
Stellate Ganglion Block as Novel Treatment for Heart Failure Patients Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Stellate Ganglion Block
- What is being tested?
- Stellate Ganglion Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 2 sitesEgypt
- Study dates
- 5 Feb 2024to 1 Jan 2025
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Not yet recruiting
Assiut University
Asyut, 71515
- Recruiting
Assiut university
Asyut, 71515
Mina Fam, Resident, +201122035368, minassfam@yahoo.com
About this study
Stellate Ganglion Block as Novel Treatment for Heart Failure Patients
Read the detailed description
Stellate Ganglion Block as Novel Treatment for Heart Failure Patients
- Conditions
- Stellate Ganglion Block
- Being tested
- Stellate Ganglion Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stellate Ganglion BlockProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Stellate Ganglion Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of left ventricular ejection fraction (LVEF).
Change of left ventricular ejection fraction (LVEF).
Measured: 3 month
Change of NYHA classification.
Change of NYHA classification.
Measured: 3 month
Secondary outcomes (4)
Change of 6 minutes walking test.
Change of 6 minutes walking test.
Measured: 3 month
Heart failure hospitalization.
Heart failure hospitalization.
Measured: 3 month
Vascular complications and safety issues.
Vascular complications and safety issues.
Measured: 3 month
Cardiovascular death.
Cardiovascular death.
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start5 Feb 2024 (estimated)
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stellate Ganglion BlockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mina sobhi said fam
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mina sobhi said fam, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06244056
- Sponsor's protocol ID
- Stellate Ganglion Block 2023
- Status last verified
- Feb 2024
- First submitted
- 17 Nov 2023
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stellate Ganglion Block as Novel Treatment for Heart Failure Patients
- ClinicalTrials.gov ID
- NCT06244056
- Acronym / sponsor ID
- Stellate Ganglion Block 2023
- Conditions
- Stellate Ganglion Block
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Mina sobhi said famUniversity, hospital or other
- Study start
- 5 Feb 2024 (estimated)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 6 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Stellate Ganglion Block as Novel Treatment for Heart Failure Patients
Detailed description
Stellate Ganglion Block as Novel Treatment for Heart Failure Patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Procedure: Stellate Ganglion Block: Narrow QRS complex Heart failure patients with optimal medical treatment with stellate ganglion block. |
| Wide QRS complex heart failure patients | Active comparator | Procedure: Stellate Ganglion BlockWide QRS complex heart failure patients with optimal medical treatment who were non responders to CRT( retrospective and prospective) with stellate ganglion block. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- Active Malignancy.
- Acute heart failure including pulmonary edema or cardiogenic shock.
- Severe, life-threatening non-cardiac disease.
- Pregnancy.
- Localized infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stellate Ganglion BlockA 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. | Procedure or surgery | : Narrow QRS complex Heart failure patients, Wide QRS complex heart failure patients |
Primary outcome
Change of left ventricular ejection fraction (LVEF).
Time frame: 3 month
Change of left ventricular ejection fraction (LVEF).
Change of NYHA classification.
Time frame: 3 month
Change of NYHA classification.
4 secondary outcomes
Change of 6 minutes walking test.
Time frame: 3 month
Heart failure hospitalization.
Time frame: 3 month
Vascular complications and safety issues.
Time frame: 3 month
Cardiovascular death.
Time frame: 3 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Stellate Ganglion Block in people with Stellate Ganglion Block, run by Mina sobhi said fam at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mina Fam, Resident (01122035368, minassfam@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of left ventricular ejection fraction (LVEF). (time frame: 3 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2024.