NCT02429557

Hemodynamic Mechanisms of Abdominal Compression in the Treatment of Orthostatic Hypotension in Autonomic Failure

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (estimated)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Orthostatic Hypotension
• Pure Autonomic Failure
• Multiple System Atrophy
• Autonomic Failure

Interventions

Type	Name	Description
OTHER	Abdominal compression	Abdominal compression of 40 mmHg with a commercial inflatable cuff applied during head up tilt
OTHER	Sham abdominal compression	Sham abdominal compression of 5 mmHg with a commercial inflatable cuff applied during head up tilt
DRUG	Placebo pill	Placebo pill given 1 hour before the second heat up tilt
DRUG	midodrine	Midodrine single dose 2.5-10mg PO given 1 hour before the second head up tilt

Timeline

• Start date: 2015-04-01
• Primary completion: 2026-11-15
• Completion: 2026-12-31
• First posted: 2015-04-29
• Last updated: 2026-01-12

Locations

1 site across 1 country: United States