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

Primary Purpose

Orthostatic Hypotension, Pure Autonomic Failure, Multiple System Atrophy

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Abdominal compression

Sham abdominal compression

Placebo pill

midodrine

About this trial

This is an interventional other trial for Orthostatic Hypotension focused on measuring autonomic failure, orthostatic hypotension, compression garments, treatment

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Sham Comparator

Experimental

Active Comparator

Arm Label

Abdominal compression and placebo pill

Sham abdominal compression and placebo

Abdominal compression and midodrine

Sham abdominal compression and midodrine

Arm Description

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

Outcomes

Primary Outcome Measures

Stroke volume

Percent change from supine in stroke volume during head up tilt

Secondary Outcome Measures

Systolic blood pressure

Change from baseline in systolic blood pressure during head up tilt

Splanchnic vascular volume

Percent change from supine in splanchnic vascular volume during head up tilt.

Full Information

NCT ID

NCT02429557

First Posted

April 21, 2015

Last Updated

March 17, 2023

Sponsor

Vanderbilt University Medical Center

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

1. Study Identification

Unique Protocol Identification Number

NCT02429557

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 2015 (Actual)

Primary Completion Date

September 1, 2024 (Anticipated)

Study Completion Date

December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Vanderbilt University Medical Center

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

autonomic failure, orthostatic hypotension, compression garments, treatment

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

29 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Abdominal compression and placebo pill

Arm Type

Experimental

Arm Description

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

Arm Title

Sham abdominal compression and placebo

Arm Type

Sham Comparator

Arm Description

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

Arm Title

Abdominal compression and midodrine

Arm Type

Experimental

Arm Description

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

Arm Title

Sham abdominal compression and midodrine

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Abdominal compression

Other Intervention Name(s)

abdominal binder

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Sham abdominal compression

Other Intervention Name(s)

abdominal binder

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo pill

Intervention Description

Placebo pill given 1 hour before the second heat up tilt

Intervention Type

Drug

Intervention Name(s)

midodrine

Other Intervention Name(s)

ProAmatine

Intervention Description

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

Primary Outcome Measure Information:

Title

Stroke volume

Description

Percent change from supine in stroke volume during head up tilt

Time Frame

an average of 15 minutes of head up tilt

Secondary Outcome Measure Information:

Title

Systolic blood pressure

Description

Change from baseline in systolic blood pressure during head up tilt

Time Frame

an average of 15 minutes of head up tilt

Title

Splanchnic vascular volume

Description

Percent change from supine in splanchnic vascular volume during head up tilt.

Time Frame

an average of 15 minutes of head up tilt

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Emily C Smith, RN

Phone

615.875.1516

autonomics@vumc.org

First Name & Middle Initial & Last Name or Official Title & Degree

Bonnie K Black, RN

Phone

615-322-3304

autonomics@vumc.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Italo Biaggioni, MD

Organizational Affiliation

Vanderbilt University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Luis E Okamoto, MD

Organizational Affiliation

Vanderbilt University Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Vanderbilt University

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Emily C Smith, RN

Phone

615-875-1516

autonomics@vumc.org

First Name & Middle Initial & Last Name & Degree

Bonnie K Black, RN

Phone

615-322-3304

autonomics@vumc.org

First Name & Middle Initial & Last Name & Degree

Italo Biaggioni, MD

First Name & Middle Initial & Last Name & Degree

Alfredo Gamboa, MD

First Name & Middle Initial & Last Name & Degree

Luis E Okamoto, MD

First Name & Middle Initial & Last Name & Degree

Cyndya A Shibao, MD

First Name & Middle Initial & Last Name & Degree

Andre Diedrich, MD/PhD

First Name & Middle Initial & Last Name & Degree

Emily C Smith, RN

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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