Ignite Creation Date:
2025-12-24 @ 6:25 PM
Ignite Modification Date:
2025-12-28 @ 3:57 AM
Study NCT ID:
NCT05193968
Status:
RECRUITING
Last Update Posted:
2025-06-03
First Post:
2021-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hot Flashes and Neurovascular Function in Women
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014636', 'term': 'Valsalva Maneuver'}, {'id': 'D009599', 'term': 'Nitroprusside'}, {'id': 'D000109', 'term': 'Acetylcholine'}, {'id': 'D013726', 'term': 'Terbutaline'}, {'id': 'D009638', 'term': 'Norepinephrine'}], 'ancestors': [{'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D006439', 'term': 'Hemodynamics'}, {'id': 'D002320', 'term': 'Cardiovascular Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}, {'id': 'D012143', 'term': 'Respiratory Physiological Phenomena'}, {'id': 'D005292', 'term': 'Ferricyanides'}, {'id': 'D003486', 'term': 'Cyanides'}, {'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D005290', 'term': 'Ferric Compounds'}, {'id': 'D058085', 'term': 'Iron Compounds'}, {'id': 'D006856', 'term': 'Hydrogen Cyanide'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D001679', 'term': 'Biogenic Amines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D015306', 'term': 'Biogenic Monoamines'}, {'id': 'D002395', 'term': 'Catecholamines'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-02-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-28', 'studyFirstSubmitDate': '2021-11-15', 'studyFirstSubmitQcDate': '2022-01-03', 'lastUpdatePostDateStruct': {'date': '2025-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare microvascular function in women with low and high frequency hot flashes', 'timeFrame': 'Continuous measurement of vascular conductance during infusion of each drug- 3min at baseline and at each drug dose (~60min total of continuous forearm vascular conductance measurements)', 'description': 'Change in forearm vascular conductance with intra-arterial drug infusions.\n\nVascular conductance is an index of vascular tone and is assessed using a technique called venous occlusion plethysmography'}, {'measure': 'Compare sympathetic function in women with low and high frequency hot flashes', 'timeFrame': 'Continuous measurement of muscle sympathetic nerve activity at rest and in response to stressors (~75min of continuous data collection once a sympathetic nerve signal is found)', 'description': 'Muscle Sympathetic Nerve Activity will be directly using a technique called microneurography.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neurovascular function', 'Autonomic function', 'Microvascular Function'], 'conditions': ['Hot Flashes', 'Menopause', 'Vasomotor System; Labile']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'Women who experience hot flashes are at greater risk for hypertension and other cardiovascular disease. Neurovascular control mechanisms are likely to play an important role in this relationship. As such, these studies are designed to provide a major step forward in understanding the link between hot flashes and neurovascular dysfunction and, by extension, cardiovascular disease in women.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non-smokers.\n* Non-obese.\n* Have at least one ovary.\n* Free from cardiovascular disease.\n* Not taking medications influencing cardiovascular function.\n\nExclusion Criteria:\n\n\\- None.'}, 'identificationModule': {'nctId': 'NCT05193968', 'briefTitle': 'Hot Flashes and Neurovascular Function in Women', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Hot Flashes and Neurovascular Function in Women', 'orgStudyIdInfo': {'id': '19-002638'}, 'secondaryIdInfos': [{'id': 'K01HL148144', 'link': 'https://reporter.nih.gov/quickSearch/K01HL148144', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Experimental: Healthy Women Volunteers', 'description': 'Hot Flash frequency will be assessed in the study subjects during a screening period. Participants can then chose to participate 1 or 2 study visits- Protocol 1: Microvascular function and/or Protocol 2: Autonomic function', 'interventionNames': ['Other: Sympathoexcitatory stressors', 'Drug: Sodium Nitroprusside', 'Drug: Acetylcholine', 'Drug: Terbutaline', 'Drug: Norepinephrine']}], 'interventions': [{'name': 'Sympathoexcitatory stressors', 'type': 'OTHER', 'otherNames': ['Valsalva maneuver, handgrip exercise, ice water, and hypercapnia'], 'description': 'Muscle sympathetic nerve activity will be measured continuously at baseline and in response to sympathoexcitatory stressors, including a Valsalva maneuver, isometric handgrip exercise, a cold pressor test, and stepped hypercapnia.', 'armGroupLabels': ['Experimental: Healthy Women Volunteers']}, {'name': 'Sodium Nitroprusside', 'type': 'DRUG', 'otherNames': ['Forearm vascular conductance response to sodium nitroprusside'], 'description': 'Sodium nitroprusside, used to test endothelium-independent vasodilation, will be infused through a brachial artery catheter at 0.25, 0.5, 1.0 and 2.0 ug/100ml tissue/min.', 'armGroupLabels': ['Experimental: Healthy Women Volunteers']}, {'name': 'Acetylcholine', 'type': 'DRUG', 'otherNames': ['Forearm vascular conductance response to acetylcholine'], 'description': 'Acetylcholine, used to test endothelium-dependent vasodilation, will be infused through a brachial artery catheter at 1.0, 2.0, 4.0, and 8.0 μg/100ml tissue/min', 'armGroupLabels': ['Experimental: Healthy Women Volunteers']}, {'name': 'Terbutaline', 'type': 'DRUG', 'otherNames': ['Forearm vascular conductance response to terbutaline'], 'description': 'Terbutaline, a β2-Adrenergic selective agonist, will be infused through a brachial artery catheter at 0.1, 0.5, 1.0, and 2.0 μg/100ml tissue/min.', 'armGroupLabels': ['Experimental: Healthy Women Volunteers']}, {'name': 'Norepinephrine', 'type': 'DRUG', 'otherNames': ['Forearm vascular conductance response to norepinephrine'], 'description': 'Norepinephrine, an α-adrenergic vasoconstricting agent, will be infused through a brachial artery catheter at 1.0, 2.0, 4.0, and 8.0 ng/100ml tissue/min', 'armGroupLabels': ['Experimental: Healthy Women Volunteers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Pamela A Engrav', 'role': 'CONTACT', 'phone': '507-255-6938'}, {'name': 'Nancy J Meyer', 'role': 'CONTACT', 'phone': '507-255-0913'}], 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'centralContacts': [{'name': 'Pamela A Engrav', 'role': 'CONTACT', 'email': 'engrav.pamela@mayo.edu', 'phone': '507-255-6938'}, {'name': 'Nancy J Meyer', 'role': 'CONTACT', 'email': 'meyer.nancy2@mayo.edu', 'phone': '507-255-0913'}], 'overallOfficials': [{'name': 'Sarah Baker, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sarah E. Baker, Ph.D.', 'investigatorAffiliation': 'Mayo Clinic'}}}}