Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2025-12-29 @ 8:13 AM
Study NCT ID:
NCT02429557
Status:
RECRUITING
Last Update Posted:
2025-06-03
First Post:
2015-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hemodynamic Mechanisms of Abdominal Compression in the Treatment of Orthostatic Hypotension in Autonomic Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007024', 'term': 'Hypotension, Orthostatic'}, {'id': 'D054970', 'term': 'Pure Autonomic Failure'}, {'id': 'D019578', 'term': 'Multiple System Atrophy'}], 'ancestors': [{'id': 'D054971', 'term': 'Orthostatic Intolerance'}, {'id': 'D054969', 'term': 'Primary Dysautonomias'}, {'id': 'D001342', 'term': 'Autonomic Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D007022', 'term': 'Hypotension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008879', 'term': 'Midodrine'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 29}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-28', 'studyFirstSubmitDate': '2015-04-21', 'studyFirstSubmitQcDate': '2015-04-23', 'lastUpdatePostDateStruct': {'date': '2025-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stroke volume', 'timeFrame': 'an average of 15 minutes of head up tilt', 'description': 'Percent change from supine in stroke volume during head up tilt'}], 'secondaryOutcomes': [{'measure': 'Systolic blood pressure', 'timeFrame': 'an average of 15 minutes of head up tilt', 'description': 'Change from baseline in systolic blood pressure during head up tilt'}, {'measure': 'Splanchnic vascular volume', 'timeFrame': 'an average of 15 minutes of head up tilt', 'description': 'Percent change from supine in splanchnic vascular volume during head up tilt.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['autonomic failure', 'orthostatic hypotension', 'compression garments', 'treatment'], 'conditions': ['Orthostatic Hypotension', 'Pure Autonomic Failure', 'Multiple System Atrophy', 'Autonomic Failure']}, 'descriptionModule': {'briefSummary': 'Compression garments have been shown to be effective in the treatment of orthostatic hypotension in autonomic failure patients. The purpose of this study is to determine the hemodynamic mechanisms by which abdominal compression (up to 40 mm Hg) improve the standing blood pressure and orthostatic tolerance in these patients, and to compare them with those of the standard of care midodrine. The investigators will test the hypothesis that abdominal compression will blunt the exaggerated fall in stroke volume and the increase in abdominal vascular volume during head up tilt.', 'detailedDescription': 'Patients with autonomic failure are characterized by disabling orthostatic hypotension (low blood pressure on standing) due to severe impairment of the autonomic nervous system. Compression garments such as waist-high stockings and abdominal binders have been shown to improve orthostatic hypotension in these patients. The purpose of this study is to determine the hemodynamic mechanisms by which abdominal compression (up to 40 mm Hg) improve the standing blood pressure and orthostatic tolerance in these patients, and to compare them with those of the standard of care midodrine. The investigators will test the hypothesis that abdominal compression will blunt the exaggerated fall in stroke volume and the increase in abdominal vascular volume during head up tilt. This study will help us better understand the contribution of the abdominal veins to orthostatic hypotension and the mechanisms underlying this non-pharmacological therapeutic approach.\n\nParticipants will be studied in a tilt table in two separate days in a randomized, crossover fashion with sham abdominal compression (\\~5 mmHg) and active compression (\\~40 mmHg).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male and female patients,\n* between 18-80 yrs.,\n* with neurogenic orthostatic hypotension associated with primary autonomic failure (Parkinson Disease, Multiple System Atrophy and Pure Autonomic Failure). Orthostatic hypotension will be defined as ≥20 mmHg decrease in systolic BP or ≥10 mmHg of diastolic BP within 3 minutes on standing associated with impaired autonomic reflexes determined by autonomic testing in the absence of other identifiable causes (Freeman et al., 2011).\n* Patients able and willing to provide informed consent.\n\nExclusion Criteria:\n\n* Pregnancy.\n* Significant cardiac, renal or hepatic illness, or with contraindications to administration of pressor agents or external abdominal compression will be excluded.\n* Clinically unstable coronary artery disease, or major cardiovascular or neurological event in the past 6 months, and; other factors which in the investigator's opinion would prevent the subject from completing the protocol including clinically significant abnormalities in clinical, mental or laboratory testing"}, 'identificationModule': {'nctId': 'NCT02429557', 'briefTitle': 'Hemodynamic Mechanisms of Abdominal Compression in the Treatment of Orthostatic Hypotension in Autonomic Failure', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Hemodynamic Mechanisms of Abdominal Compression in the Treatment of Orthostatic Hypotension in Autonomic Failure', 'orgStudyIdInfo': {'id': '140634'}, 'secondaryIdInfos': [{'id': '1R01HL144568-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01HL144568-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Abdominal compression and placebo pill', 'description': 'Abdominal compression with an inflatable abdominal binder (up to 40 mmHg) during head up tilt, and placebo pill given 1 hour before the second head up tilt', 'interventionNames': ['Other: Abdominal compression', 'Drug: Placebo pill']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham abdominal compression and placebo', 'description': 'Sham abdominal compression with an inflatable abdominal binder (\\~5 mmHg) during head up tilt, and placebo pill given 1 hour before the second head up tilt', 'interventionNames': ['Other: Sham abdominal compression', 'Drug: Placebo pill']}, {'type': 'EXPERIMENTAL', 'label': 'Abdominal compression and midodrine', 'description': 'Abdominal compression with an inflatable abdominal binder (up to 40 mmHg) during head up tilt, and midodrine 2.5-10 mg PO given 1 hour before the second head up tilt', 'interventionNames': ['Other: Abdominal compression', 'Drug: midodrine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sham abdominal compression and midodrine', 'description': 'Sham abdominal compression with an inflatable abdominal binder (\\~5 mmHg) during head up tilt, and midodrine 2.5-10mg PO given 1 hour before the second head up tilt', 'interventionNames': ['Other: Sham abdominal compression', 'Drug: midodrine']}], 'interventions': [{'name': 'Abdominal compression', 'type': 'OTHER', 'otherNames': ['abdominal binder'], 'description': 'Abdominal compression of 40 mmHg with a commercial inflatable cuff applied during head up tilt', 'armGroupLabels': ['Abdominal compression and midodrine', 'Abdominal compression and placebo pill']}, {'name': 'Sham abdominal compression', 'type': 'OTHER', 'otherNames': ['abdominal binder'], 'description': 'Sham abdominal compression of 5 mmHg with a commercial inflatable cuff applied during head up tilt', 'armGroupLabels': ['Sham abdominal compression and midodrine', 'Sham abdominal compression and placebo']}, {'name': 'Placebo pill', 'type': 'DRUG', 'description': 'Placebo pill given 1 hour before the second heat up tilt', 'armGroupLabels': ['Abdominal compression and placebo pill', 'Sham abdominal compression and placebo']}, {'name': 'midodrine', 'type': 'DRUG', 'otherNames': ['ProAmatine'], 'description': 'Midodrine single dose 2.5-10mg PO given 1 hour before the second head up tilt', 'armGroupLabels': ['Abdominal compression and midodrine', 'Sham abdominal compression and midodrine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Emily C Smith, RN', 'role': 'CONTACT', 'email': 'autonomics@vumc.org', 'phone': '615.875.1516'}, {'name': 'Bonnie K Black, RN', 'role': 'CONTACT', 'email': 'autonomics@vumc.org', 'phone': '615-322-3304'}, {'name': 'Italo Biaggioni, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Alfredo Gamboa, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Luis E Okamoto, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Cyndya A Shibao, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Andre Diedrich, MD/PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Emily C Smith, RN', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Vanderbilt University', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'centralContacts': [{'name': 'Bonnie K Black, RN', 'role': 'CONTACT', 'email': 'autonomics@vumc.org', 'phone': '615-343-6862'}, {'name': 'Luis E. Okamoto, MD', 'role': 'CONTACT', 'email': 'luis.e.okamoto@vumc.org', 'phone': '(615) 936-6119'}], 'overallOfficials': [{'name': 'Italo Biaggioni, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University'}, {'name': 'Luis E Okamoto, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Assistant Professor', 'investigatorFullName': 'Luis E Okamoto', 'investigatorAffiliation': 'Vanderbilt University Medical Center'}}}}