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

Trial ID: NCT02429557

Interventional - Phase 1 - Completed

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

• Abdominal compression
• Sham abdominal compression
• Placebo pill
• midodrine

Eligibility

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

Sponsor

Vanderbilt University Medical Center, National Heart, Lung, and Blood Institute (NHLBI)

Source: ClinicalTrials.gov

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