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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
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

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

First Posted
April 21, 2015
Last Updated
March 17, 2023
Sponsor
Vanderbilt University Medical Center
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

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
No
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
Email
autonomics@vumc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Bonnie K Black, RN
Phone
615-322-3304
Email
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
Email
autonomics@vumc.org
First Name & Middle Initial & Last Name & Degree
Bonnie K Black, RN
Phone
615-322-3304
Email
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
No

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

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