Hemodynamic Mechanisms of Abdominal Compression in the Treatment of Orthostatic Hypotension in Autonomic Failure
Key facts
- Who runs it
- Vanderbilt University Medical Center
- Where
- Nashville, United StatesSee the site
- Trial code
- Status
- Completed
- Phase
- Phase 1
- People taking part
- 21 people enrolled
- Started
- Apr 2015
- Ended
- 31 Dec 2025
- Type of study
- Interventional, 4 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Abdominal compression
- Sham abdominal compression
- Placebo pill
- midodrine
- Record updated
- 5 May 2026
Who can take part
- Age
- 18 years to 80 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- Pregnancy
Where in United States
- Vanderbilt UniversityNashville, United StatesNo longer taking part
About the trial
What the trial wants to find out
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.
The 4 groups in the trial
- Abdominal compression and placebo pillTreatment being tested
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
Treatment: Abdominal compression and Placebo pill
- Sham abdominal compression and placeboSham treatment, for comparison
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
Treatment: Sham abdominal compression and Placebo pill
- Abdominal compression and midodrineTreatment being tested
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
Treatment: Abdominal compression and midodrine
- Sham abdominal compression and midodrineExisting treatment, for comparison
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
Treatment: Sham abdominal compression and midodrine
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 5 May 2026