Ignite Creation Date:
2025-12-24 @ 1:21 PM
Ignite Modification Date:
2025-12-29 @ 6:58 PM
Study NCT ID:
NCT07077395
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-15
First Post:
2025-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Finding Links Between Hot flASHes and CardioVascular Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019584', 'term': 'Hot Flashes'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2030-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-12', 'studyFirstSubmitDate': '2025-07-11', 'studyFirstSubmitQcDate': '2025-07-11', 'lastUpdatePostDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'brachial artery flow mediated dilation', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'concentration of inflammatory protein biomarkers', 'timeFrame': '12 weeks', 'description': '* General inflammatory markers: hsCRP, IL-8, TNF-ɑ/β\n* Leukocyte adhesion markers: MCP-1, ICAM-1\n* Markers of vascular homeostasis: ANGPT1, VEGFA, HB-EGF'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['menopause', 'hot flashes', 'heart health'], 'conditions': ['Menopause-related Hot Flashes']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if neurokinin-1/neurokinin-3 receptor antagonist elinzanetant improves blood vessel health in women with moderate to severe hot flashes. The main questions it aims to answer is does neurokinin-1/neurokinin-3 receptor antagonist elinzanetant improve blood vessel health?'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 40-65 years\n* Peri- and post-menopausal women (STRAW -1 to +1)\n* Moderate or high vasmotor symptom burden\n* Cardiometabolic disease (as evidenced by ≥ 2 of the following):\n\n * Obesity (body mass index ≥ 30 kg/m2)\n * Elevated waist circumference (≥ 88 cm)\n * Elevated triglycerides (≥ 150 mg/dL or drug treatment)\n * Reduced HDL-cholesterol (\\<50 mg/dL or drug treatment)\n * Elevated blood pressure (≥ 130 mmHg systolic blood pressure or ≥ 85 mmHg diastolic blood pressure, or drug treatment)\n * Elevated fasting glucose (≥ 100 mg/dL or drug treatment)\n\nExclusion Criteria:\n\n* Inability to provide informed consent or comply with study protocol\n* Major comorbidities: cancer, end-stage renal (eGFR \\<45 mL/min/1.73 m2), liver or lung disease\n* Concomitant use of strong or moderate cytochrome P450 3A4 inhibitors\n* Elevated liver function tests (ALT, AST, and/or total bilirubin ≥2x ULN)\n* Undiagnosed uterine bleeding over past 6 months'}, 'identificationModule': {'nctId': 'NCT07077395', 'acronym': 'FLASH-CV:', 'briefTitle': 'Finding Links Between Hot flASHes and CardioVascular Disease', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Finding Links Between Hot flASHes and CardioVascular Disease', 'orgStudyIdInfo': {'id': '2025p001738'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'elinzanetant 120 mg daily for 12 weeks', 'interventionNames': ['Drug: elinzanetant - reference formulation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo daily for 12 weeks', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'elinzanetant - reference formulation', 'type': 'DRUG', 'description': 'elinzanetant 120 mg daily x 12 weeks', 'armGroupLabels': ['elinzanetant 120 mg daily for 12 weeks']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'placebo daily x 12 weeks', 'armGroupLabels': ['Placebo daily for 12 weeks']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'contacts': [{'name': 'Kamila Bielawski', 'role': 'CONTACT', 'email': 'mghflashcv@mgb.org', 'phone': '617-724-3064'}], 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'contacts': [{'name': 'Kamila Bielawski', 'role': 'CONTACT', 'email': 'mghflashcv@mgb.org', 'phone': '617-643-6161'}], 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Kamila Bielawski', 'role': 'CONTACT', 'email': 'mghflashcv@mgb.org', 'phone': '617-724-3064'}], 'overallOfficials': [{'name': 'Emily Lau, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Emily Lau', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}