Ignite Creation Date:
2025-12-24 @ 2:50 PM
Ignite Modification Date:
2025-12-26 @ 1:45 PM
Study NCT ID:
NCT00748059
Status:
COMPLETED
Last Update Posted:
2021-05-12
First Post:
2008-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Pathophysiology of Orthostatic Hypotension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001342', 'term': 'Autonomic Nervous System Diseases'}, {'id': 'D007024', 'term': 'Hypotension, Orthostatic'}, {'id': 'C535600', 'term': 'dopamine beta hydroxylase deficiency'}, {'id': 'D054971', 'term': 'Orthostatic Intolerance'}, {'id': 'D004244', 'term': 'Dizziness'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D054969', 'term': 'Primary Dysautonomias'}, {'id': 'D007022', 'term': 'Hypotension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012678', 'term': 'Sensation Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078783', 'term': 'Standing Position'}, {'id': 'D010656', 'term': 'Phenylephrine'}, {'id': 'D003000', 'term': 'Clonidine'}], 'ancestors': [{'id': 'D011187', 'term': 'Posture'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D048288', 'term': 'Imidazolines'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1996-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2020-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-07', 'studyFirstSubmitDate': '2008-09-05', 'studyFirstSubmitQcDate': '2008-09-05', 'lastUpdatePostDateStruct': {'date': '2021-05-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-09-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'hemodynamic changes with standing', 'timeFrame': 'following test'}], 'secondaryOutcomes': [{'measure': 'blood and urine hormones', 'timeFrame': 'after test'}, {'measure': 'blood volume', 'timeFrame': 'during supine and/or upright postures'}, {'measure': 'sympathetic nerve activity', 'timeFrame': 'during stimulation of sympathetic nervous system'}, {'measure': 'quantitative sweat testing', 'timeFrame': '2 hours'}, {'measure': 'Eye function', 'timeFrame': 'once'}, {'measure': 'Sleep efficiency', 'timeFrame': 'once'}, {'measure': 'Metabolic rate', 'timeFrame': 'once'}, {'measure': 'Pain response', 'timeFrame': 'once'}, {'measure': 'Responses on questionnaires and computer tasks designed to assess brain function', 'timeFrame': 'once'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['autonomic nervous system diseases', 'blood pressure', 'congenital', 'orthostasis', 'catecholamines'], 'conditions': ['Autonomic Nervous System Diseases', 'Orthostatic Hypotension', 'Dopamine Beta-Hydroxylase Deficiency', 'Orthostatic Intolerance']}, 'referencesModule': {'references': [{'pmid': '27778639', 'type': 'DERIVED', 'citation': 'Arnold AC, Garland EM, Celedonio JE, Raj SR, Abumrad NN, Biaggioni I, Robertson D, Luther JM, Shibao CA. Hyperinsulinemia and Insulin Resistance in Dopamine beta-Hydroxylase Deficiency. J Clin Endocrinol Metab. 2017 Jan 1;102(1):10-14. doi: 10.1210/jc.2016-3274.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the cause of low blood pressure in selective patients who have problems with their involuntary (autonomic) nervous system. These patients frequently have had symptoms throughout their life, and their disorder might have a genetic basis. The biochemical, physiological and pharmacological procedures in this study should help us define the problem and perhaps lead to more effective treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* severe orthostatic hypotension and other autonomic symptoms but do not meet criteria for standard diagnosis\n* non-smokers\n* drug-free\n* able to give informed consent\n* free of pulmonary, renal, hematopoietic, hepatic and cardiac disease\n\nExclusion Criteria:\n\n* medications affecting the autonomic nervous system\n* any chronic illness\n* anemia (Hct\\<30)\n* women of childbearing age who are pregnant or nursing\n* smokers'}, 'identificationModule': {'nctId': 'NCT00748059', 'briefTitle': 'The Pathophysiology of Orthostatic Hypotension', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'The Pathophysiology of Orthostatic Hypotension', 'orgStudyIdInfo': {'id': '030752'}, 'secondaryIdInfos': [{'id': 'HL056693'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'Patients with Orthostatic Hypotension', 'interventionNames': ['Procedure: Standing or upright tilt', 'Procedure: Microneurography', 'Procedure: QSweat', 'Device: neck cuff stimulation', 'Drug: phenylephrine,isoproterenol,nitroprusside,propranolol,edrophonium,atropine,tyramine', 'Drug: clonidine,yohimbine,metoclopramide,alpha-methyldopa', 'Procedure: BodPod', 'Procedure: Eye exam', 'Procedure: Sleep study', 'Procedure: Pain response testing', 'Procedure: Metabolic chamber', 'Procedure: Brain function studies', 'Procedure: Bicycle Exercise Test']}], 'interventions': [{'name': 'Standing or upright tilt', 'type': 'PROCEDURE', 'description': 'stand upright or tilt table test', 'armGroupLabels': ['A']}, {'name': 'Microneurography', 'type': 'PROCEDURE', 'description': 'Recording from sympathetic nerve', 'armGroupLabels': ['A']}, {'name': 'QSweat', 'type': 'PROCEDURE', 'description': 'quantitative sweat testing', 'armGroupLabels': ['A']}, {'name': 'neck cuff stimulation', 'type': 'DEVICE', 'description': 'Blood pressure receptors in the neck arteries may be stimulated by applying suction through a collar around the neck.', 'armGroupLabels': ['A']}, {'name': 'phenylephrine,isoproterenol,nitroprusside,propranolol,edrophonium,atropine,tyramine', 'type': 'DRUG', 'description': 'IV Pharmacological Testing\n\nphenylephrine 12.5 - 400 ug, isoproterenol 0.1 - 0.4 ug or higher until desired effect, nitroprusside 0.1 - 1.6 ug/kg, propranolol 1.1 mg/min, edrophonium maximum of 10 mg, atropine .01 mg/kg, tyramine 250-4000 ug or higher until desired effect', 'armGroupLabels': ['A']}, {'name': 'clonidine,yohimbine,metoclopramide,alpha-methyldopa', 'type': 'DRUG', 'description': 'Oral Pharmacological Testing\n\nclonidine 0.1-0.3 mg, yohimbine 5-10 mg, metoclopramide 10 mg, alpha-methyldopa 62.5 mg, placebo', 'armGroupLabels': ['A']}, {'name': 'BodPod', 'type': 'PROCEDURE', 'description': 'Determination of body composition', 'armGroupLabels': ['A']}, {'name': 'Eye exam', 'type': 'PROCEDURE', 'description': 'Examination of pressure in the eye and eyelid fatiguability. The following eyedrops might be used:\n\n1. 0.5% proparacaine (Alcaine, Allergan, Inc)\n2. Fluress (0.4% benoxinate hydrochloride, fluorescein sodium, Akorn, Inc)\n3. 0.5%, 1% tropicamide (Mydriacyl, Alcon)\n4. Over-the-counter preservative-free artificial tears\n5. 0.25%, 2.5% and 10% phenylephrine (Bausch and Lomb)\n6. 1% cyclopentolate hydrochloride (Alcon)', 'armGroupLabels': ['A']}, {'name': 'Sleep study', 'type': 'PROCEDURE', 'description': 'Recording of sleep pattern overnight', 'armGroupLabels': ['A']}, {'name': 'Pain response testing', 'type': 'PROCEDURE', 'description': 'Subjects will rate the quality and intensity of 2 pain tasks.', 'armGroupLabels': ['A']}, {'name': 'Metabolic chamber', 'type': 'PROCEDURE', 'description': 'Determination of metabolic rate via 24hr stay in whole-room indirect calorimeter', 'armGroupLabels': ['A']}, {'name': 'Brain function studies', 'type': 'PROCEDURE', 'description': 'Questionnaires and computer tasks, an EEG and an MRI may be used to assess brain function.', 'armGroupLabels': ['A']}, {'name': 'Bicycle Exercise Test', 'type': 'PROCEDURE', 'description': 'Blood pressure and heart rate may be monitored while exercising on a stationary bicycle.', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Emily M Garland, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Associate Professor', 'investigatorFullName': 'Emily M. Garland', 'investigatorAffiliation': 'Vanderbilt University Medical Center'}}}}