Ignite Creation Date:
2025-12-24 @ 11:21 PM
Ignite Modification Date:
2025-12-25 @ 9:04 PM
Study NCT ID:
NCT06244056
Status:
RECRUITING
Last Update Posted:
2024-02-06
First Post:
2023-11-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Stellate Ganglion Block as Novel Treatment for Heart Failure Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 108}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-02', 'studyFirstSubmitDate': '2023-11-17', 'studyFirstSubmitQcDate': '2024-02-02', 'lastUpdatePostDateStruct': {'date': '2024-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of left ventricular ejection fraction (LVEF).', 'timeFrame': '3 month', 'description': 'Change of left ventricular ejection fraction (LVEF).'}, {'measure': 'Change of NYHA classification.', 'timeFrame': '3 month', 'description': 'Change of NYHA classification.'}], 'secondaryOutcomes': [{'measure': 'Change of 6 minutes walking test.', 'timeFrame': '3 month', 'description': 'Change of 6 minutes walking test.'}, {'measure': 'Heart failure hospitalization.', 'timeFrame': '3 month', 'description': 'Heart failure hospitalization.'}, {'measure': 'Vascular complications and safety issues.', 'timeFrame': '3 month', 'description': 'Vascular complications and safety issues.'}, {'measure': 'Cardiovascular death.', 'timeFrame': '3 month', 'description': 'Cardiovascular death.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stellate Ganglion Block']}, 'descriptionModule': {'briefSummary': 'Stellate Ganglion Block as Novel Treatment for Heart Failure Patients', 'detailedDescription': 'Stellate Ganglion Block as Novel Treatment for Heart Failure Patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 18 : 70 years old.\n* NYHA Class III-IV Heart Failure.\n* Heart failure with a reduced ejection fraction (HFrEF) LVEF ≤ 40% calculated using 2D echocardiography and Biplane Simpson's .\n* Optimal tolerated Medical Therapy for Heart Failure.\n\nExclusion Criteria:\n\n* Active Malignancy.\n* Acute heart failure including pulmonary edema or cardiogenic shock.\n* Severe, life-threatening non-cardiac disease.\n* Pregnancy.\n* Localized infection.\n* Coagulopathy or anticoagulated patients.\n* Refused this procedure."}, 'identificationModule': {'nctId': 'NCT06244056', 'briefTitle': 'Stellate Ganglion Block as Novel Treatment for Heart Failure Patients', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Stellate Ganglion Block as Novel Treatment for Heart Failure Patients', 'orgStudyIdInfo': {'id': 'Stellate Ganglion Block 2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Narrow QRS complex Heart failure patients', 'description': 'Narrow QRS complex Heart failure patients with optimal medical treatment.'}, {'type': 'ACTIVE_COMPARATOR', 'label': ': Narrow QRS complex Heart failure patients', 'description': ': Narrow QRS complex Heart failure patients with optimal medical treatment with stellate ganglion block.', 'interventionNames': ['Procedure: Stellate Ganglion Block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Wide QRS complex heart failure patients', 'description': 'Wide QRS complex heart failure patients with optimal medical treatment who were non responders to CRT( retrospective and prospective) with stellate ganglion block.', 'interventionNames': ['Procedure: Stellate Ganglion Block']}], 'interventions': [{'name': 'Stellate Ganglion Block', 'type': 'PROCEDURE', '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.', 'armGroupLabels': [': Narrow QRS complex Heart failure patients', 'Wide QRS complex heart failure patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71515', 'city': 'Asyut', 'status': 'NOT_YET_RECRUITING', 'country': 'Egypt', 'facility': 'Assiut University', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}, {'zip': '71515', 'city': 'Asyut', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mina Fam, Resident', 'role': 'CONTACT', 'email': 'minassfam@yahoo.com', 'phone': '+201122035368'}], 'facility': 'Assiut university', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Mina Fam, Resident', 'role': 'CONTACT', 'email': 'minassfam@yahoo.com', 'phone': '01122035368'}, {'name': 'Aly Tohamy, Lecturer', 'role': 'CONTACT', 'email': 'Ali.tohamy@gmail.com', 'phone': 'Ali.tohamy@gmail.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mina sobhi said fam', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'resident doctor', 'investigatorFullName': 'Mina sobhi said fam', 'investigatorAffiliation': 'Assiut University'}}}}