Hemodynamic Mechanisms of Abdominal Compression in the Treatment of Orthostatic Hypotension in Autonomic Failure
Orthostatic Hypotension, Pure Autonomic Failure, Multiple System Atrophy
About this trial
This is an interventional other trial for Orthostatic Hypotension focused on measuring autonomic failure, orthostatic hypotension, compression garments, treatment
Eligibility Criteria
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
Sites / Locations
- Vanderbilt UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Sham Comparator
Experimental
Active Comparator
Abdominal compression and placebo pill
Sham abdominal compression and placebo
Abdominal compression and midodrine
Sham abdominal compression and midodrine
Abdominal compression with an inflatable abdominal binder (up to 40 mmHg) during head up tilt, and placebo pill given 1 hour before the second head up tilt
Sham abdominal compression with an inflatable abdominal binder (~5 mmHg) during head up tilt, and placebo pill given 1 hour before the second head up tilt
Abdominal compression with an inflatable abdominal binder (up to 40 mmHg) during head up tilt, and midodrine 2.5-10 mg PO given 1 hour before the second head up tilt
Sham abdominal compression with an inflatable abdominal binder (~5 mmHg) during head up tilt, and midodrine 2.5-10mg PO given 1 hour before the second head up tilt