Ignite Creation Date:
2025-12-24 @ 1:29 PM
Ignite Modification Date:
2026-01-07 @ 6:58 AM
Study NCT ID:
NCT00838695
Status:
COMPLETED
Last Update Posted:
2018-10-26
First Post:
2009-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Variability in Adrenergic Response
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010656', 'term': 'Phenylephrine'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mike.stein@vumc.org', 'phone': '615-936-3420', 'title': 'Dr. C. Michael Stein', 'organization': 'VAnderbilt University Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Findings derived from dorsal hand veins and cannot automatically be extrapolated to other vascular beds.\n\nWomen were not studied at predefined periods of menstrual cycle or account for use of hormonal contraceptives.\n\nSome genotype groups were small.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were documented for participants from time they began diet of at least 4 days to end of study day.', 'eventGroups': [{'id': 'EG000', 'title': 'African Americans', 'description': 'Participants who were of African American descent.', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 0, 'seriousNumAtRisk': 42, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Caucasians', 'description': 'Participants who were of Caucasian descent.', 'otherNumAtRisk': 64, 'deathsNumAtRisk': 64, 'otherNumAffected': 0, 'seriousNumAtRisk': 64, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'ED50 After Phenylephrine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'African Americans', 'description': "Subjects' hand veins will be measured for maximum constriction while being infused with phenylephrine, and then mental stress and cold pressor testing\n\nPhenylephrine: Intravenous phenylephrine at low doses (approximately 10 doses ranging from 0-5000 ng/min) Intravenous nitroglycerin at low doses (approximately 10 doses ranging from 0.05-100 ng/min)"}, {'id': 'OG001', 'title': 'Caucasians', 'description': "Subjects' hand veins will be measured for maximum constriction while being infused with phenylephrine, and then mental stress and cold pressor testing\n\nPhenylephrine: Intravenous phenylephrine at low doses (approximately 10 doses ranging from 0-5000 ng/min) Intravenous nitroglycerin at low doses (approximately 10 doses ranging from 0.05-100 ng/min)"}], 'classes': [{'categories': [{'measurements': [{'value': '172', 'groupId': 'OG000', 'lowerLimit': '115', 'upperLimit': '256'}, {'value': '310', 'groupId': 'OG001', 'lowerLimit': '222', 'upperLimit': '434'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '70 minutes', 'description': 'ED50 is a measurement of vein constriction and indicates 50% of maximal constriction after being given medication phenylephrine, representing sensitivity to the drug. Phenylephrine was infused at increasing dose rates, ranging from 12-9600 ng/min. The infusion at each dose rate lasted 7 minutes, with the vein diameter measured during the last 2 minutes of the infusion. The number represents the ng/ml of phenylephrine needed to reach 50% of maximal vein constriction. ED50 values were not normally distributed and were log-transformed for analysis and expressed as geometric means.', 'unitOfMeasure': 'ng/min', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'African Americans', 'description': "Subjects' hand veins will be measured for maximum constriction while being infused with phenylephrine, and then mental stress and cold pressor testing\n\nPhenylephrine: Intravenous phenylephrine at low doses (approximately 10 doses ranging from 0-5000 ng/min) Intravenous nitroglycerin at low doses (approximately 10 doses ranging from 0.05-100 ng/min)"}, {'id': 'OG001', 'title': 'Caucasians', 'description': "Subjects' hand veins will be measured for maximum constriction while being infused with phenylephrine, and then mental stress and cold pressor testing\n\nPhenylephrine: Intravenous phenylephrine at low doses (approximately 10 doses ranging from 0-5000 ng/min) Intravenous nitroglycerin at low doses (approximately 10 doses ranging from 0.05-100 ng/min)"}], 'classes': [{'title': 'Change in Systolic Blood Pressure', 'categories': [{'measurements': [{'value': '23.0', 'spread': '12.3', 'groupId': 'OG000'}, {'value': '18.9', 'spread': '11.7', 'groupId': 'OG001'}]}]}, {'title': 'Change in Diastolic Blood pressure', 'categories': [{'measurements': [{'value': '16.9', 'spread': '9.3', 'groupId': 'OG000'}, {'value': '16.4', 'spread': '8.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 2 minutes', 'description': 'change in systolic and diastolic blood pressure, comparing before and after cold pressor test. A subset of 57 participants (of the 106) who were in the primary outcome measure also participated in the cold pressor test.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A subset of participants (57 of the 106) in the primary outcome measure also participated in the cold pressor test.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'African Americans', 'description': "Subjects' hand veins will be measured for maximum constriction while being infused with phenylephrine, and then mental stress and cold pressor testing\n\nPhenylephrine: Intravenous phenylephrine at low doses (approximately 10 doses ranging from 0-5000 ng/min) Intravenous nitroglycerin at low doses (approximately 10 doses ranging from 0.05-100 ng/min)"}, {'id': 'FG001', 'title': 'Caucasians', 'description': "Subjects' hand veins will be measured for maximum constriction while being infused with phenylephrine, and then mental stress and cold pressor testing\n\nPhenylephrine: Intravenous phenylephrine at low doses (approximately 10 doses ranging from 0-5000 ng/min) Intravenous nitroglycerin at low doses (approximately 10 doses ranging from 0.05-100 ng/min)"}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '64'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '64'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects were recruited by advertisement within the Vanderbilt University campus and through the Vanderbilt University Clinical Research Center study volunteer database,'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'African Americans', 'description': "Subjects' hand veins will be measured for maximum constriction while being infused with phenylephrine, and then mental stress and cold pressor testing\n\nPhenylephrine: Intravenous phenylephrine at low doses (approximately 10 doses ranging from 0-5000 ng/min) Intravenous nitroglycerin at low doses (approximately 10 doses ranging from 0.05-100 ng/min)"}, {'id': 'BG001', 'title': 'Caucasians', 'description': "Subjects' hand veins will be measured for maximum constriction while being infused with phenylephrine, and then mental stress and cold pressor testing\n\nPhenylephrine: Intravenous phenylephrine at low doses (approximately 10 doses ranging from 0-5000 ng/min) Intravenous nitroglycerin at low doses (approximately 10 doses ranging from 0.05-100 ng/min)"}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '28.1', 'spread': '8', 'groupId': 'BG000'}, {'value': '26.9', 'spread': '6.8', 'groupId': 'BG001'}, {'value': '27', 'spread': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'plasma norepinephrine', 'classes': [{'categories': [{'measurements': [{'value': '179.5', 'spread': '70.8', 'groupId': 'BG000'}, {'value': '162.3', 'spread': '58', 'groupId': 'BG001'}, {'value': '168.9', 'spread': '63.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'plasma epinephrine', 'classes': [{'categories': [{'measurements': [{'value': '21.0', 'spread': '15.6', 'groupId': 'BG000'}, {'value': '18.5', 'spread': '12.5', 'groupId': 'BG001'}, {'value': '19.4', 'spread': '13.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-25', 'studyFirstSubmitDate': '2009-02-04', 'resultsFirstSubmitDate': '2018-09-21', 'studyFirstSubmitQcDate': '2009-02-05', 'lastUpdatePostDateStruct': {'date': '2018-10-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-10-25', 'studyFirstPostDateStruct': {'date': '2009-02-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ED50 After Phenylephrine', 'timeFrame': '70 minutes', 'description': 'ED50 is a measurement of vein constriction and indicates 50% of maximal constriction after being given medication phenylephrine, representing sensitivity to the drug. Phenylephrine was infused at increasing dose rates, ranging from 12-9600 ng/min. The infusion at each dose rate lasted 7 minutes, with the vein diameter measured during the last 2 minutes of the infusion. The number represents the ng/ml of phenylephrine needed to reach 50% of maximal vein constriction. ED50 values were not normally distributed and were log-transformed for analysis and expressed as geometric means.'}], 'secondaryOutcomes': [{'measure': 'Change in Blood Pressure', 'timeFrame': 'baseline to 2 minutes', 'description': 'change in systolic and diastolic blood pressure, comparing before and after cold pressor test. A subset of 57 participants (of the 106) who were in the primary outcome measure also participated in the cold pressor test.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hand vein sensitivity', 'phenylephrine', 'nitroglycerin'], 'conditions': ['Vascular Reaction to Medications']}, 'referencesModule': {'references': [{'pmid': '23399717', 'type': 'RESULT', 'citation': 'Adefurin A, Ghimire LV, Kohli U, Muszkat M, Sofowora GG, Paranjape SY, Stein CM, Kurnik D. Blacks have a greater sensitivity to alpha1-adrenoceptor-mediated venoconstriction compared with whites. Hypertension. 2013 Apr;61(4):915-20. doi: 10.1161/HYPERTENSIONAHA.111.00854. Epub 2013 Feb 11.'}, {'pmid': '25421140', 'type': 'RESULT', 'citation': 'Adefurin A, Ghimire LV, Kohli U, Muszkat M, Sofowora GG, Li C, Paranjape SY, Stein CM, Kurnik D. Genetic variation in the alpha1A-adrenergic receptor and phenylephrine-mediated venoconstriction. Pharmacogenomics J. 2015 Aug;15(4):310-5. doi: 10.1038/tpj.2014.69. Epub 2014 Nov 25.'}, {'pmid': '27089938', 'type': 'RESULT', 'citation': 'Adefurin A, Ghimire LV, Kohli U, Muszkat M, Sofowora GG, Li C, Levinson RT, Paranjape SY, Stein CM, Kurnik D. Genetic variation in the alpha1B-adrenergic receptor and vascular response. Pharmacogenomics J. 2017 Jul;17(4):366-371. doi: 10.1038/tpj.2016.29. Epub 2016 Apr 19.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this project is to determine the genetic factors contributing to interindividual differences in response to physiological and pharmacological vasoconstrictors and vasodilators.', 'detailedDescription': 'The dorsal hand vein model is a relatively non-invasive and robust experimental model to examine the local in vivo effect of vasoactive drugs without elucidating systemic counterregulatory reflexes. Infusion of incremental low doses of phenylephrine into a dorsal hand vein results in increasing local venoconstriction, without systemic effects. Similarly, infusion of incremental low doses of nitroglycerin into a preconstricted dorsal hand vein results in increasing local venodilation, without systemic effects. Systemic vascular responses can be measured by the cold pressor test (CPT),that leads to increase in blood pressure and heart rate , or mental stress that is also known to stimulate cardiovascular responses. Individuals vary in their local and systemic vascular responses but the genetic determinants of these are not clear.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age between 18 and 40 years, inclusive.\n* Subject must be willing to give written informed consent and be able to adhere to diet and study schedules.\n* Subjects must be free of any clinically significant disease that requires a physician's care and/or would interfere with the study evaluations.\n* Subjects must have a normal or clinically acceptable physical examination and ECG.\n* Clinical laboratory tests (CBC, blood chemistries, and urinalysis) must be within normal limits or clinically acceptable to the investigator.\n\nExclusion Criteria:\n\n* Any subject who has taken any prescription or over-the-counter drugs, other than oral contraception if female, within two weeks prior to study drug administration.\n* Subjects who are presently, or were formerly, narcotic addicts or alcoholics.\n* Subjects who have a clinically significant allergy/intolerance to phenylephrine.\n* Females with a positive serum/urine pregnancy test at screening.\n* Females who are nursing.\n* Subject using sildenafil or other phosphodiesterase inhibitors."}, 'identificationModule': {'nctId': 'NCT00838695', 'briefTitle': 'Variability in Adrenergic Response', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Variability in Adrenergic Response', 'orgStudyIdInfo': {'id': '71148'}, 'secondaryIdInfos': [{'id': 'P01HL056693', 'link': 'https://reporter.nih.gov/quickSearch/P01HL056693', 'type': 'NIH'}, {'id': '1UL1RR024975', 'link': 'https://reporter.nih.gov/quickSearch/1UL1RR024975', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'African Americans', 'description': "Subjects' hand veins will be measured for maximum constriction while being infused with phenylephrine, and then mental stress and cold pressor testing", 'interventionNames': ['Drug: Phenylephrine']}, {'type': 'EXPERIMENTAL', 'label': 'Caucasians', 'description': "Subjects' hand veins will be measured for maximum constriction while being infused with phenylephrine, and then mental stress and cold pressor testing", 'interventionNames': ['Drug: Phenylephrine']}], 'interventions': [{'name': 'Phenylephrine', 'type': 'DRUG', 'otherNames': ['generic medications used,not applicable'], 'description': 'Intravenous phenylephrine at low doses (approximately 10 doses ranging from 0-5000 ng/min) Intravenous nitroglycerin at low doses (approximately 10 doses ranging from 0.05-100 ng/min)', 'armGroupLabels': ['African Americans', 'Caucasians']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Charles M Stein, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}, {'name': 'National Center for Research Resources (NCRR)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dan May Professor of Medicine, Professor of Pharmacology, Assistant Director of the Division of Clinical Pharmacology', 'investigatorFullName': 'C. Michael Stein', 'investigatorAffiliation': 'Vanderbilt University'}}}}