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

NCT ID: NCT02429557

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2026-12-31

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.

Detailed Description

Patients with autonomic failure are characterized by disabling orthostatic hypotension (low blood pressure on standing) due to severe impairment of the autonomic nervous system. Compression garments such as waist-high stockings and abdominal binders have been shown to improve orthostatic hypotension in these 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. This study will help us better understand the contribution of the abdominal veins to orthostatic hypotension and the mechanisms underlying this non-pharmacological therapeutic approach.

Participants will be studied in a tilt table in two separate days in a randomized, crossover fashion with sham abdominal compression (~5 mmHg) and active compression (~40 mmHg).

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Abdominal compression and placebo pill

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

Group Type: EXPERIMENTAL

Abdominal compression

Intervention Type: OTHER

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

Placebo pill

Intervention Type: DRUG

Placebo pill given 1 hour before the second heat up tilt

Sham abdominal compression and placebo

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

Group Type: SHAM_COMPARATOR

Sham abdominal compression

Intervention Type: OTHER

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

Placebo pill

Intervention Type: DRUG

Placebo pill given 1 hour before the second heat up tilt

Abdominal compression and midodrine

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

Group Type: EXPERIMENTAL

Abdominal compression

Intervention Type: OTHER

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

midodrine

Intervention Type: DRUG

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

Sham abdominal compression and midodrine

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

Group Type: ACTIVE_COMPARATOR

Sham abdominal compression

Intervention Type: OTHER

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

midodrine

Intervention Type: DRUG

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

Interventions

Abdominal compression

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

Intervention Type: OTHER

Sham abdominal compression

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

Intervention Type: OTHER

Placebo pill

Placebo pill given 1 hour before the second heat up tilt

Intervention Type: DRUG

midodrine

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

Intervention Type: DRUG

Other Intervention Names

abdominal binder; abdominal binder; ProAmatine

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Luis E Okamoto

Research Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Italo Biaggioni, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Luis E Okamoto, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Vanderbilt University

Nashville, Tennessee, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Bonnie K Black, RN

Role: CONTACT

autonomics@vumc.org

615-343-6862

Luis E. Okamoto, MD

Role: CONTACT

luis.e.okamoto@vumc.org

(615) 936-6119

Facility Contacts

Emily C Smith, RN

Role: primary

autonomics@vumc.org

615.875.1516

Bonnie K Black, RN

Role: backup

autonomics@vumc.org

615-322-3304

Other Identifiers

1R01HL144568-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

140634

Identifier Type: -

Identifier Source: org_study_id