Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2025-12-25 @ 8:06 PM
Study NCT ID:
NCT04952935
Status:
UNKNOWN
Last Update Posted:
2021-07-07
First Post:
2021-05-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Acupuncture for the Treatment of Medication-Dependent Hypotension in Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D007022', 'term': 'Hypotension'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': "Patient receives true or sham acupuncture, and patient is unaware of treatment assignment. Acupuncturist is aware of treatment assignment, as is the statistician who is aware of randomization assignment but not involved otherwise in the execution of clinical trial. Investigators, medical assistants, and patients' physicians are unaware of treatment assignment."}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized double-blinded sham-controlled clinical trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2022-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-02', 'studyFirstSubmitDate': '2021-05-21', 'studyFirstSubmitQcDate': '2021-07-02', 'lastUpdatePostDateStruct': {'date': '2021-07-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood Pressure', 'timeFrame': '9 weeks', 'description': 'Change in mean arterial blood pressure, as measured by blood pressure cuff in sitting position'}], 'secondaryOutcomes': [{'measure': 'Blood Pressure adjusted for Medication', 'timeFrame': '9 weeks', 'description': 'Change in mean arterial blood pressure, as measured by blood pressure cuff in sitting position, adjusted for midodrine/fludrocortisone dose as covariate'}, {'measure': 'Standing Blood Pressure adjusted for Medication', 'timeFrame': '9 weeks', 'description': 'Change in mean arterial blood pressure, as measured by blood pressure cuff in standing position, adjusted for midodrine/fludrocortisone dose as covariate'}, {'measure': 'Medication Dose Change', 'timeFrame': '9 weeks', 'description': 'Percentage change in median dose of midodrine or fludrocortisone (in mg per week)'}, {'measure': 'Got off medications', 'timeFrame': '9 weeks', 'description': 'Number of patients who came off of midodrine or fludrocortisone by end of study'}, {'measure': 'NYHA Class', 'timeFrame': 'Start, 5 weeks, and 9 weeks', 'description': 'Change in NYHA Class'}, {'measure': 'Quality of Life Score', 'timeFrame': 'Start, 5 weeks, and 9 weeks', 'description': 'Change in Quality of Life scores by VAS'}, {'measure': 'Composite Safety Outcome', 'timeFrame': 'Throughout study, total time 9 weeks', 'description': 'Composite of skin injury, symptomatic hypotension, hospitalization for heart failure exacerbation or syncope or hypotension, implantation of LVAD/MCS device or heart transplantation, or all-cause death'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['acupuncture', 'midodrine', 'fludrocortisone', 'randomized controlled trial'], 'conditions': ['Congestive Heart Failure', 'Hypotension']}, 'descriptionModule': {'briefSummary': 'Acupuncture is believed to increase blood pressure in people who struggle with low blood pressure. This is a common problem facing people with heart failure, and sometimes these people need to take medications to artificially increase their blood pressure. This study is designed to determine if using acupuncture in people with heart failure can improve their blood pressure enough to not require medications to artificially increase blood pressure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age greater than or equal to 18 years old\n* Chronic congestive heart failure (systolic or diastolic)\n* Medication list includes midodrine or fludrocortisone, either taking as scheduled or as needed\n\nExclusion Criteria:\n\n* History of acupuncture of any kind in the last 3 months\n* Acute decompensated heart failure, as indicated by clinical picture at time of enrollment\n* Currently on a mechanical device (LVAD, TAH, ECMO)\n* History of hepatorenal syndrome, adrenal insufficiency, for which midodrine and fludrocortisone respectively is specifically being used to treat that condition\n* Lack of suitable locations for which to place acupuncture seeds'}, 'identificationModule': {'nctId': 'NCT04952935', 'briefTitle': 'Acupuncture for the Treatment of Medication-Dependent Hypotension in Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Scripps Health'}, 'officialTitle': 'Acupuncture for the Treatment of Medication-Dependent Hypotension in Heart Failure', 'orgStudyIdInfo': {'id': 'IRB-20-7569'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'True Acupuncture', 'interventionNames': ['Procedure: True Acupuncture']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham Acupuncture', 'interventionNames': ['Procedure: Sham Acupuncture']}], 'interventions': [{'name': 'True Acupuncture', 'type': 'PROCEDURE', 'description': 'Delivery of four acupuncture seeds (no needles involved) to the head and neck area at true acupuncture points.', 'armGroupLabels': ['True Acupuncture']}, {'name': 'Sham Acupuncture', 'type': 'PROCEDURE', 'description': 'Delivery of four acupuncture seeds (no needles involved) to the head and neck area at non-acupuncture points.', 'armGroupLabels': ['Sham Acupuncture']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Yu-Ming Ni, MD', 'role': 'CONTACT', 'email': 'acupunctureHF@scrippshealth.org', 'phone': '858-554-3360'}, {'name': 'Christopher Suhar, MD', 'role': 'CONTACT', 'phone': '858-554-3300'}, {'name': 'Yu-Ming Ni, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Christopher Suhar, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Rajeev Mohan, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Scripps La Jolla Medical Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Yu-Ming Ni, MD', 'role': 'CONTACT', 'email': 'acupunctureHF@scrippshealth.org', 'phone': '858-554-3360'}, {'name': 'Christopher Suhar, MD', 'role': 'CONTACT', 'phone': '858-554-3300'}, {'name': 'Yu-Ming Ni, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Christopher Suhar, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Rajeev Mohan, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Scripps Shiley Integrative Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}], 'centralContacts': [{'name': 'Yu-Ming Ni, MD', 'role': 'CONTACT', 'email': 'acupunctureHF@scrippshealth.org', 'phone': '858-554-3360'}, {'name': 'Christopher Suhar, MD', 'role': 'CONTACT', 'phone': '858-554-3300'}], 'overallOfficials': [{'name': 'Christopher Suhar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Scripps Health'}, {'name': 'Yu-Ming Ni, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Scripps Health'}, {'name': 'Rajeev Mohan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Scripps Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Scripps Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Cardiology Fellow', 'investigatorFullName': 'Yu-Ming Ni', 'investigatorAffiliation': 'Scripps Health'}}}}