Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
31 participants
INTERVENTIONAL
2018-03-01
2026-12-01
Brief Summary
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Detailed Description
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Potential participants will be admitted to the Vanderbilt Clinical Research Center for evaluation of inclusion and exclusion criteria. Eligible patients will be randomized to the active or sham binder group. Patients will then be asked to participate on three separate study days, two days apart: one day for baseline measurements (placebo pill t.i.d), one day for treatment with 10 mg midodrine t.i.d (standard of care), and one day for treatment with active or sham binder combined with placebo pill t.i.d. The order of the study days will be randomized. On each study day, blood pressure and heart rate will be measured while sitting, lying down, standing and walking during the Morning Orthostatic Trial, and posture and walking tests.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Automated Abdominal Binder
Participants will be studied on three separate study days, two days apart: one day for baseline measurements (placebo pill t.i.d), one day for treatment with 10 mg midodrine t.i.d (standard of care), and one day for treatment with the automated abdominal binder combined with placebo pill t.i.d The automated abdominal binder will be placed during the morning orthostatic trial on the active/sham binder study day. The binder will inflate automatically (\~40 mmHg) every time the participant stands up throughout the study day.
automated abdominal binder
The binder automatically inflates every time the participant stands up to apply a compression level of about 40 mmHg. Participants will wear the device throughout the active/sham study day.
Placebo
Oral placebo will be given three times a day on the baseline day (placebo)
Midodrine
A midodrine pill 10mg will be given three times a day on the standard of care study day
Sham binder
Participants will be studied on three separate study days, two days apart: one day for baseline measurements (placebo pill t.i.d), one day for treatment with 10 mg midodrine t.i.d (standard of care), and one day for treatment with the sham binder combined with placebo pill t.i.d. The sham binder will be placed during the morning orthostatic trial on the active/sham binder study day. The sham binder will inflate automatically (\~5 mmHg) every time the participant stands up throughout the study day.
Sham binder
The binder automatically inflates every time the participant stands up to apply a compression level of about 5 mmHg. Participants will wear the device throughout the active/sham study day.
Placebo
Oral placebo will be given three times a day on the baseline day (placebo)
Midodrine
A midodrine pill 10mg will be given three times a day on the standard of care study day
Interventions
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automated abdominal binder
The binder automatically inflates every time the participant stands up to apply a compression level of about 40 mmHg. Participants will wear the device throughout the active/sham study day.
Sham binder
The binder automatically inflates every time the participant stands up to apply a compression level of about 5 mmHg. Participants will wear the device throughout the active/sham study day.
Placebo
Oral placebo will be given three times a day on the baseline day (placebo)
Midodrine
A midodrine pill 10mg will be given three times a day on the standard of care study day
Eligibility Criteria
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Inclusion Criteria
* Possible or probable Multiple Systems Atrophy and Pure Autonomic Failure as defined by Consensus Criteria.
* Neurogenic orthostatic hypotension defined as a ≥30-mm Hg decrease in SBP within 3 minutes of standing associated with impaired autonomic reflexes determined by autonomic testing in the absence of other identifiable causes, and
* Moderate to severe orthostatic symptoms, defined as an Orthostatic Hypotension Symptom Assessment (OHSA) composite score ≥4 (self-rating Likert scale of 0 to 10, with 0 reflecting absence of symptoms), within the first 10 minutes of the screening orthostatic stress test, and that have an impact in quality of life, as defined by the patient.
* Able and willing to provide informed consent.
Exclusion Criteria
* Systemic illnesses known to produce autonomic neuropathy, including but not limited to diabetes mellitus, amyloidosis, monoclonal gammopathies, and autoimmune neuropathies.
* History of known aortic aneurisms, thoracic, abdominal or pelvic surgery in the past 6 months; symptomatic abdominal or inguinal hernias; severe gastroesophageal reflux; recent fractures or fissures of ribs, thoracic or lumbar spine; medical devices implanted on the abdominal wall or abdomen that would interfere with the binder; known abdominal or pelvic tumors, cysts or enlarged spleen; intolerance to any increase in intraabdominal pressure.
* Pre-existing sustained supine hypertension ≥180/110.
* Bedridden patients or those who are unable to stand due to motor impairment or severe orthostatic hypotension.
* Clinically unstable coronary artery disease (recurrent angina despite medical therapy), or major cardiovascular or neurological event in the past 6 months (myocardial infarction, stroke or transient ischemic attacks).
* Concomitant use of anticoagulants
40 Years
80 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Vanderbilt University Medical Center
OTHER
Responsible Party
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Luis E Okamoto
Research Assistant Professor
Principal Investigators
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Italo Biaggioni, MD
Role: PRINCIPAL_INVESTIGATOR
Professor of Medicine and Pharmacology
Luis E Okamoto, MD
Role: PRINCIPAL_INVESTIGATOR
Research Assistant Professor
Locations
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Autonomic Dysfunction Center/ Vanderbilt University Medical Center
Nashville, Tennessee, United States
Countries
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Central Contacts
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Facility Contacts
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Luis Okamoto, MD
Role: primary
Andre Diedrich, MD PhD
Role: backup
Other Identifiers
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151008
Identifier Type: -
Identifier Source: org_study_id