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



Status:Recruiting
Conditions:Other Indications, Cardiology, Cardiology, Neurology
Therapuetic Areas:Cardiology / Vascular Diseases, Neurology, Other
Healthy:No
Age Range:18 - 80
Updated:2/6/2019
Start Date:April 2015
End Date:July 2020
Contact:Emily C Smith, RN
Email:autonomics@vumc.org
Phone:615.875.1516

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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).

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
We found this trial at
1
site
2201 West End Ave
Nashville, Tennessee 37232
(615) 322-7311
Principal Investigator: Italo Biaggioni, MD
Phone: 615-875-1516
Vanderbilt University Vanderbilt offers undergraduate programs in the liberal arts and sciences, engineering, music, education...
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Nashville, TN
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