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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HL144568-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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.
Participants 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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abdominal compression and placebo pill | Experimental | 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 |
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| Sham abdominal compression and placebo | Sham Comparator | 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 |
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| Abdominal compression and midodrine | Experimental | 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 |
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| Sham abdominal compression and midodrine | Active Comparator | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abdominal compression | Other | Abdominal compression of 40 mmHg with a commercial inflatable cuff applied during head up tilt |
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| Measure | Description | Time Frame |
|---|---|---|
| Stroke volume | Percent change from supine in stroke volume during head up tilt | an average of 15 minutes of head up tilt |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic blood pressure | Change from baseline in systolic blood pressure during head up tilt | an average of 15 minutes of head up tilt |
| Splanchnic vascular volume | Percent change from supine in splanchnic vascular volume during head up tilt. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Italo Biaggioni, MD | Vanderbilt University | Principal Investigator |
| Luis E Okamoto, MD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University | Nashville | Tennessee | 37232 | United States |
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| Sham abdominal compression | Other | Sham abdominal compression of 5 mmHg with a commercial inflatable cuff applied during head up tilt |
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| Placebo pill | Drug | Placebo pill given 1 hour before the second heat up tilt |
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| midodrine | Drug | Midodrine single dose 2.5-10mg PO given 1 hour before the second head up tilt |
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| an average of 15 minutes of head up tilt |
| ID | Term |
|---|---|
| D007024 | Hypotension, Orthostatic |
| D054970 | Pure Autonomic Failure |
| D019578 | Multiple System Atrophy |
| ID | Term |
|---|---|
| D054971 | Orthostatic Intolerance |
| D054969 | Primary Dysautonomias |
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D007022 | Hypotension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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| ID | Term |
|---|---|
| D008879 | Midodrine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
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