A Phase 1 interventional study of Abdominal compression and Sham abdominal compression in Orthostatic Hypotension, Pure Autonomic Failure and Multiple System Atrophy, sponsored by Vanderbilt University Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-05-05.
Sponsored by Vanderbilt University Medical Center · Phase 1, Interventional, and Other
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).
155 studies on the registry are indexed under Hypotension, Orthostatic; 34 are open to participants now.
This study's enrollment of 21 is below the median of 30 across 113 interventional studies indexed under Hypotension, Orthostatic.
Browse Hypotension, Orthostatic studies →Vanderbilt University Medical Center is the lead sponsor of 824 studies on the registry; 164 are open to participants now.
Of its 122 completed or terminated interventional studies of FDA-regulated products, 91 (75%) have results posted.
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Exclusion Criteria:
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
Other: Abdominal compression · Drug: Placebo pill
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
Other: Sham abdominal compression · Drug: Placebo pill
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
Other: Abdominal compression · Drug: midodrine
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
Other: Sham abdominal compression · Drug: midodrine
Abdominal compression of 40 mmHg with a commercial inflatable cuff applied during head up tilt
Also known as: abdominal binder
Sham abdominal compression of 5 mmHg with a commercial inflatable cuff applied during head up tilt
Also known as: abdominal binder
Placebo pill given 1 hour before the second heat up tilt
Midodrine single dose 2.5-10mg PO given 1 hour before the second head up tilt
Also known as: ProAmatine
Stroke volume
Percent change from supine in stroke volume during head up tilt
Time frame: an average of 15 minutes of head up tilt
Systolic blood pressure
Change from baseline in systolic blood pressure during head up tilt
Time frame: an average of 15 minutes of head up tilt
Splanchnic vascular volume
Percent change from supine in splanchnic vascular volume during head up tilt.
Time frame: an average of 15 minutes of head up tilt
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Vanderbilt University Medical Center