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

  • STATUS
    Recruiting
  • End date
    Dec 1, 2024
  • participants needed
    29
  • sponsor
    Vanderbilt University Medical Center
Updated on 4 October 2022
stroke
midodrine
atrophy
parkinson's disease
multiple system atrophy
orthostatic hypotension
pure 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.

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).

Details
Condition Orthostatic Hypotension, Pure Autonomic Failure, Multiple System Atrophy, Autonomic Failure
Treatment Placebo Pill, Midodrine, Abdominal compression, Sham abdominal compression
Clinical Study IdentifierNCT02429557
SponsorVanderbilt University Medical Center
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Male and female patients
between 18-80 yrs
with neurogenic orthostatic hypotension associated with primary autonomic failure (Parkinson Disease, Multiple System Atrophy and Pure Autonomic Failure). Orthostatic hypotension will be defined as ≥20 mmHg decrease in systolic BP or ≥10 mmHg of diastolic BP within 3 minutes on standing associated with impaired autonomic reflexes determined by autonomic testing in the absence of other identifiable causes (Freeman et al., 2011)
Patients able and willing to provide informed consent

Exclusion Criteria

Pregnancy
Significant cardiac, renal or hepatic illness, or with contraindications to administration of pressor agents or external abdominal compression will be excluded
Clinically unstable coronary artery disease, or major cardiovascular or neurological event in the past 6 months, and; other factors which in the investigator's opinion would prevent the subject from completing the protocol including clinically significant abnormalities in clinical, mental or laboratory testing
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