Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2026-04-07 @ 2:52 PM
Study NCT ID:
NCT02116335
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-01-28
First Post:
2014-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endothelin Receptor Function and Acute Stress
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077300', 'term': 'Bosentan'}, {'id': 'D007785', 'term': 'Lactose'}], 'ancestors': [{'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004187', 'term': 'Disaccharides'}, {'id': 'D009844', 'term': 'Oligosaccharides'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D000073893', 'term': 'Sugars'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 320}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-27', 'studyFirstSubmitDate': '2014-04-14', 'studyFirstSubmitQcDate': '2014-04-15', 'lastUpdatePostDateStruct': {'date': '2025-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-04-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Flow-Mediated Dilation (FMD)', 'timeFrame': 'Baseline and 3 days', 'description': 'Brachial artery FMD induced by reactive hyperemia will be used to assess vascular endothelial function.'}], 'secondaryOutcomes': [{'measure': 'Arterial Stiffness Evaluation (PWV)', 'timeFrame': 'Baseline and 3 days', 'description': 'A tonometer will be gently applied on the carotid artery and then the femoral artery and the radial artery to record how fast blood flows between each of the points.'}, {'measure': 'Physio Flow', 'timeFrame': 'Baseline and 3 days', 'description': 'Six surface electrodes will be placed on the body. 2 on the neck, 2 on the chest, and 2 on the back in order to measure parameters of the heart during exercise.'}, {'measure': 'Femoral blood flow', 'timeFrame': 'Baseline and 3 days', 'description': 'Though ultrasound assessment; resistance of the blood flow, blood flow, blood velocity, and arterial diameter will all be measured in the femoral artery during the physically induced stress test which involves submerging the subjects hand in ice water for 3 minutes.'}, {'measure': 'Blood Pressure', 'timeFrame': 'Baseline and 3 days', 'description': 'Blood pressure will measured in response to the physically induced stress test which involves submerging the subjects hand in ice water for 3 minutes.'}, {'measure': 'Resting Energy Expenditure', 'timeFrame': 'Baseline and 3 days', 'description': 'REE will be assessed before and following treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['arterial stiffness', 'flow-mediated dilation', 'endothelial function', 'pulse wave velocity', 'inflammation', 'oxidative stress', 'Nitric Oxide', 'Cold Pressor Test', 'physio flow', 'Bosentan', 'Endothelin Receptor', 'Endothelin-1', 'BMI', 'stress', 'blood pressure'], 'conditions': ['Hypertension']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.livep.net', 'label': 'Laboratory of Integrative Vascular and Exercise Physiology'}]}, 'descriptionModule': {'briefSummary': 'Our bodies respond differently to stress. Animal studies by the investigators have found that endothelin-1 plays a role in regulating blood pressure in response to stress. This study is an extension of the investigators previous animal work to evaluate the role of endothelin-1 during stress in humans.', 'detailedDescription': 'Using a salt sensitive animal model of prehypertension, the Dahl S rat,the investigators have previously published that acute stress elicits a pressor response that is accompanied by an increase in 8 isoprostane and endothelin-1. However, the pressor response is suppressed by endothelin A/B receptor antagonism. Moreover, the investigators have identified that the increase in 8-isoprostane occurs downstream of endothelin receptor activation. These data indicate that endothelin receptor activation is a main player In the pressor response to acute stress in pre-hypertensive animals; however, this phenomenon has yet to be elucidated in humans.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and premenopausal women (Ages 18-50 years old)\n* Self-reported Black and White adults\n* Lean adults (BMl \\<25 kg/m\\^)\n* Obese adults (BMl \\> 30 kg/m\\^)\n\nExclusion Criteria:\n\n* Having a BMI less than 16 kg/m2 (severely and very severely underweight) or that is greater than 40 kg/m2 (Class III obesity)\n* Having evidence of cardiovascular, pulmonary, renal, hepatic, cerebral, or metabolic disease\n* Having evidence of pregnancy\n* Using medications that affect vascular tone (i.e., nitrates, etc.)\n* Postmenopausal women\n* Uncontrolled hypertension\n* Individuals who are on a restricted salt diet\n* Having a history of chronic pain\n* Having a history of rheumatoid arthritis\n* Using medications that are contraindicated with bosentan (i.e. glyburide, cyclosporine)\n* Liver dysfunction (which may be identified with the blood sample we take)'}, 'identificationModule': {'nctId': 'NCT02116335', 'acronym': 'End-Stress', 'briefTitle': 'Endothelin Receptor Function and Acute Stress', 'organization': {'class': 'OTHER', 'fullName': 'Augusta University'}, 'officialTitle': 'Endothelin Receptor Function and Acute Stress (End-Stress)', 'orgStudyIdInfo': {'id': 'End-Stress'}, 'secondaryIdInfos': [{'id': '5P01HL069999', 'link': 'https://reporter.nih.gov/quickSearch/5P01HL069999', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bosentan', 'description': 'Sub-Chronic (3 days) Bosentan 250mg/day.', 'interventionNames': ['Drug: Bosentan']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Stress response and endothelial function will be determined following a three day treatment of placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Bosentan', 'type': 'DRUG', 'otherNames': ['Tracleer'], 'description': 'Stress response and vascular function will be assessed 3 days following 125 mg twice per day of Bosentan', 'armGroupLabels': ['Bosentan']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['lactose capsule'], 'description': 'Stress response and vascular function will be assessed 3 days following twice per day placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30912', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Georgia Regents University', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}], 'overallOfficials': [{'name': 'Ryan Harris, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Augusta University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Augusta University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Ryan Harris', 'investigatorAffiliation': 'Augusta University'}}}}