Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2026-03-02 @ 4:03 PM
Study NCT ID:
NCT00581633
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-06
First Post:
2007-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Salt Handling in Orthostatic Intolerance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054972', 'term': 'Postural Orthostatic Tachycardia Syndrome'}, {'id': 'D054971', 'term': 'Orthostatic Intolerance'}, {'id': 'D013610', 'term': 'Tachycardia'}], 'ancestors': [{'id': 'D054969', 'term': 'Primary Dysautonomias'}, {'id': 'D001342', 'term': 'Autonomic Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2029-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-03', 'studyFirstSubmitDate': '2007-12-22', 'studyFirstSubmitQcDate': '2007-12-22', 'lastUpdatePostDateStruct': {'date': '2025-10-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2029-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Urinary Na excretion', 'timeFrame': '24h and then hourly post saline load'}], 'secondaryOutcomes': [{'measure': 'Catecholamine levels', 'timeFrame': '1 day'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['saline', 'sodium', 'kidney', 'tachycardia'], 'conditions': ['Postural Tachycardia Syndrome', 'Orthostatic Tachycardia', 'Orthostatic Intolerance']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.vumc.org/autonomic-dysfunction-center/vanderbilt-autonomic-dysfunction', 'label': 'Vanderbilt Autonomic Dysfunction Center'}]}, 'descriptionModule': {'briefSummary': 'The investigators will test the hypothesis that patients with chronic orthostatic intolerance or postural orthostatic tachycardia syndrome (OI or POTS) will be unable to conserve urinary sodium as compared to healthy control subjects.', 'detailedDescription': 'Patients with chronic OI appear to be hypovolemic with abnormalities in hormones that regulate salt \\& water handling. Increases in dietary salt have salutary effects on orthostatic tolerance in a physiological laboratory. The infusion of intravenous saline acutely decreased heart rate in this patient population. Preliminary data from Vanderbilt suggests abnormal salt handling in patients with chronic OI in a few patients. These data need to be confirmed and a better understanding of sodium handling in response to acute salt loads is required in these patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with orthostatic intolerance by Vanderbilt Autonomic Dysfunction Center (or healthy control subject)\n\nExclusion Criteria:\n\n* Overt or acute cause for orthostatic tachycardia\n* Hypertension (BP\\>145/95 or need for anti-hypertensive medications)\n* QRS duration \\> 120 msec on EKG\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT00581633', 'briefTitle': 'Acute Salt Handling in Orthostatic Intolerance', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Acute Renal Salt Handling in Orthostatic Intolerance', 'orgStudyIdInfo': {'id': '061230'}, 'secondaryIdInfos': [{'id': 'UL1RR024975', 'link': 'https://reporter.nih.gov/quickSearch/UL1RR024975', 'type': 'NIH'}, {'id': 'K23RR020783', 'link': 'https://reporter.nih.gov/quickSearch/K23RR020783', 'type': 'NIH'}, {'id': 'P01HL056693', 'link': 'https://reporter.nih.gov/quickSearch/P01HL056693', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'saline infusion for sodium loading', 'interventionNames': ['Other: normal saline (0.9%)']}], 'interventions': [{'name': 'normal saline (0.9%)', 'type': 'OTHER', 'description': 'liter normal saline over 30 minutes x 1 dose', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Satish R Raj, MD MSCI', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Research Resources (NCRR)', 'class': 'NIH'}, {'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine & Pharmacology', 'investigatorFullName': 'Satish R. Raj', 'investigatorAffiliation': 'Vanderbilt University'}}}}