Using abdominal compression to treat low blood pressure when standing in patients with autonomic failure

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

This study tests if wearing abdominal compression garments can help people with autonomic failure manage low blood pressure when standing.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Vanderbilt University Medical Center (Academic / other)
• Locations: 1 site (Nashville, Tennessee)
• Trial ID: NCT02429557 on ClinicalTrials.gov

What this trial studies

This study investigates how abdominal compression garments can improve blood pressure and tolerance to standing in patients with autonomic failure experiencing orthostatic hypotension. It aims to understand the hemodynamic mechanisms behind this non-pharmacological treatment by comparing the effects of active compression to sham compression and the standard medication, midodrine. Participants will undergo testing in a tilt table setup on two separate days to assess changes in blood pressure and stroke volume. The findings could enhance our understanding of the role of abdominal veins in managing orthostatic hypotension.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 with neurogenic orthostatic hypotension due to primary autonomic failure conditions such as Parkinson's disease or multiple system atrophy.

Not a fit: Patients with significant cardiac, renal, or hepatic illnesses, or those who are pregnant, may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a non-pharmacological treatment option for patients suffering from debilitating low blood pressure upon standing.

How similar studies have performed: Previous studies have shown that compression garments can be effective in treating orthostatic hypotension, suggesting potential success for this approach.

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

Where this trial is running

Nashville, Tennessee

• Vanderbilt University — Nashville, Tennessee, United States (Recruiting)

Study contacts

• Principal investigator: Italo Biaggioni, MD — Vanderbilt University
• Study coordinator: Bonnie K Black, RN

Conditions Orthostatic Hypotension; Pure Autonomic Failure; Multiple System Atrophy; Autonomic Failure; autonomic failure; orthostatic hypotension; compression garments; treatment