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

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.

Conditions

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

Interventions

DRUG

midodrine

Midodrine single dose 2.5-10mg PO given 1 hour before the second head up tilt

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

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Vanderbilt University Medical Center

  lead OTHER

Principal Investigators

• Italo Biaggioni, MD · Vanderbilt University

• Luis E Okamoto, MD · Vanderbilt University Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-04-30

Primary Completion

2025-12-31

Completion

2025-12-31

Countries

• United States

Study Locations