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

NCT02429557 | Completed Phase 1

• 2 other identifiers: 1406341R01HL144568-01A1
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pure Autonomic Failure; Orthostatic Hypotension; Multiple System Atrophy; Autonomic Failure

Keywords

autonomic failure; orthostatic hypotension; compression garments; treatment

Outcome Measures

Primary Outcomes (1)

• Stroke volume

  Percent change from supine in stroke volume during head up tilt

  an average of 15 minutes of head up tilt

Secondary Outcomes (2)

• Systolic blood pressure

  an average of 15 minutes of head up tilt

• Splanchnic vascular volume

  an average of 15 minutes of head up tilt

Study Arms (4)

Abdominal compression and placebo pill

EXPERIMENTAL

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

Other: Abdominal compression; Drug: Placebo pill

Sham abdominal compression and placebo

SHAM COMPARATOR

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

Other: Sham abdominal compression; Drug: Placebo pill

Abdominal compression and midodrine

EXPERIMENTAL

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

Other: Abdominal compression; Drug: midodrine

Sham abdominal compression and midodrine

ACTIVE COMPARATOR

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

Other: Sham abdominal compression; Drug: midodrine

Interventions

Placebo pill DRUG

Placebo pill given 1 hour before the second heat up tilt

Abdominal compression and placebo pill; Sham abdominal compression and placebo

midodrine DRUG

Midodrine single dose 2.5-10mg PO given 1 hour before the second head up tilt

Also known as: ProAmatine

Abdominal compression and midodrine; Sham abdominal compression and midodrine

Sham abdominal compression OTHER

Sham abdominal compression of 5 mmHg with a commercial inflatable cuff applied during head up tilt

Also known as: abdominal binder

Sham abdominal compression and midodrine; Sham abdominal compression and placebo

Abdominal compression OTHER

Abdominal compression of 40 mmHg with a commercial inflatable cuff applied during head up tilt

Also known as: abdominal binder

Abdominal compression and midodrine; Abdominal compression and placebo pill

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Hypotension, Orthostatic; Pure Autonomic Failure; Multiple System Atrophy

Interventions

Midodrine

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Hypotension; Vascular Diseases; Cardiovascular Diseases; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Study Officials

• Italo Biaggioni, MD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

• Luis E Okamoto, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: April 21, 2015
• First Posted: April 29, 2015
• Study Start: April 1, 2015
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)