Hemodynamic Mechanisms of Abdominal Compression in the Treatment of Orthostatic Hypotension in Autonomic Failure
Vanderbilt University Medical Center
29 participants
Apr 1, 2015
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- 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 Criteria3
- 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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Interventions
Abdominal compression of 40 mmHg with a commercial inflatable cuff applied during head up tilt
Sham abdominal compression of 5 mmHg with a commercial inflatable cuff applied during head up tilt
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
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT02429557