Vanderbilt University
Nashville, Tennessee, 37232, United States
NCT Number: NCT02429557
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.
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Notify Me18 year–80 year
All sexes
Interventional
Phase 1
Nashville, Tennessee, 37232, United States
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Abdominal compression of 40 mmHg with a commercial inflatable cuff applied during head up tilt
Other names: abdominal binder
Sham abdominal compression of 5 mmHg with a commercial inflatable cuff applied during head up tilt
Other names: 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
Other names: ProAmatine
Time frame: an average of 15 minutes of head up tilt
Percent change from supine in stroke volume during head up tilt
Time frame: an average of 15 minutes of head up tilt
Change from baseline in systolic blood pressure during head up tilt
Time frame: an average of 15 minutes of head up tilt
Percent change from supine in splanchnic vascular volume during head up tilt.
Vanderbilt University Medical Center
Other
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