Ignite Creation Date:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2026-03-14 @ 8:21 AM
Study NCT ID:
NCT01000350
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-08
First Post:
2009-10-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intravenous (IV) Saline and Exercise in Postural Tachycardia Syndrome (POTS)
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': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2028-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-03', 'studyFirstSubmitDate': '2009-10-21', 'studyFirstSubmitQcDate': '2009-10-22', 'lastUpdatePostDateStruct': {'date': '2025-10-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in VO2max between saline day and placebo day', 'timeFrame': 'Within 2 week', 'description': 'VO2max will be measured hours after saline and after placebo. The 2 interventions will be less than 2 weeks apart.'}], 'secondaryOutcomes': [{'measure': 'Exercise capacity/Maximal Load (Watts) during peak VO2', 'timeFrame': 'Less than 2 weeks', 'description': 'Maximal exercise load will be measured hours after saline and after placebo. The 2 interventions will be less than 2 weeks apart.'}, {'measure': 'Cardiac output between exercise tests (inert gas rebreathing technique)', 'timeFrame': '2-10 Days between exercise tests'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['orthostatic intolerance', 'exercise capacity', 'tachycardia', 'POTS'], 'conditions': ['Postural Tachycardia Syndrome']}, 'referencesModule': {'references': [{'pmid': '15781744', 'type': 'BACKGROUND', 'citation': 'Raj SR, Biaggioni I, Yamhure PC, Black BK, Paranjape SY, Byrne DW, Robertson D. Renin-aldosterone paradox and perturbed blood volume regulation underlying postural tachycardia syndrome. Circulation. 2005 Apr 5;111(13):1574-82. doi: 10.1161/01.CIR.0000160356.97313.5D. Epub 2005 Mar 21.'}]}, 'descriptionModule': {'briefSummary': 'The investigators will test whether an intravenous infusion of saline (salt water) will improve the exercise capacity in patients with postural tachycardia syndrome (POTS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Meet diagnostic criteria of Postural Tachycardia Syndrome (POTS) 28\n* Age between 18-65 years\n* Male and female are eligible (although the majority of POTS patients are female).\n* Able and willing to provide informed consent\n\nExclusion Criteria:\n\n* Presence of medical conditions that can explain postural tachycardia (e.g., acute dehydration, medications)\n* Pregnancy\n* Other factors which in the investigator's opinion would prevent the subject from completing the protocol.\n* Patients who are bedridden or chair-ridden"}, 'identificationModule': {'nctId': 'NCT01000350', 'briefTitle': 'Intravenous (IV) Saline and Exercise in Postural Tachycardia Syndrome (POTS)', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Intravenous Saline on Exercise Tolerance in Orthostatic Intolerance', 'orgStudyIdInfo': {'id': '090942'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise Post Saline', 'description': 'Saline infusion 1L hours before exercise test', 'interventionNames': ['Drug: Saline']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo given prior to exercise test', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Saline', 'type': 'DRUG', 'otherNames': ['Normal Saline', '0.9% saline'], 'description': 'IV Normal Saline infused over 30-60 minutes given 3-6 hours PRIOR to exercise study', 'armGroupLabels': ['Exercise Post Saline']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo x1 lactose tablet', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232-2195', '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'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Adjunct Associate Professor of Medicine', 'investigatorFullName': 'Satish R. Raj', 'investigatorAffiliation': 'Vanderbilt University Medical Center'}}}}