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Automated Abdominal Binder for Orthostatic Hypotension

Primary Purpose

Orthostatic Hypotension, Autonomic Failure, Pure Autonomic Failure

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

automated abdominal binder

Sham binder

Placebo

Midodrine

About this trial

This is an interventional treatment trial for Orthostatic Hypotension focused on measuring orthostatic hypotension, abdominal binder, pure autonomic failure, multiple system atrophy

Eligibility Criteria

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

Inclusion Criteria:

Male and female subjects, age 40-80 years.
Possible or probable Multiple Systems Atrophy and Pure Autonomic Failure as defined by Consensus Criteria.
Neurogenic orthostatic hypotension defined as a ≥30-mm Hg decrease in SBP within 3 minutes of standing associated with impaired autonomic reflexes determined by autonomic testing in the absence of other identifiable causes, and
Moderate to severe orthostatic symptoms, defined as an Orthostatic Hypotension Symptom Assessment (OHSA) composite score ≥4 (self-rating Likert scale of 0 to 10, with 0 reflecting absence of symptoms), within the first 10 minutes of the screening orthostatic stress test, and that have an impact in quality of life, as defined by the patient.
Able and willing to provide informed consent.

Exclusion Criteria:

Pregnancy.
Systemic illnesses known to produce autonomic neuropathy, including but not limited to diabetes mellitus, amyloidosis, monoclonal gammopathies, and autoimmune neuropathies.
History of known aortic aneurisms, thoracic, abdominal or pelvic surgery in the past 6 months; symptomatic abdominal or inguinal hernias; severe gastroesophageal reflux; recent fractures or fissures of ribs, thoracic or lumbar spine; medical devices implanted on the abdominal wall or abdomen that would interfere with the binder; known abdominal or pelvic tumors, cysts or enlarged spleen; intolerance to any increase in intraabdominal pressure.
Pre-existing sustained supine hypertension ≥180/110.
Bedridden patients or those who are unable to stand due to motor impairment or severe orthostatic hypotension.
Clinically unstable coronary artery disease (recurrent angina despite medical therapy), or major cardiovascular or neurological event in the past 6 months (myocardial infarction, stroke or transient ischemic attacks).
Concomitant use of anticoagulants

Sites / Locations

Autonomic Dysfunction Center/ Vanderbilt University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Automated Abdominal Binder

Sham binder

Arm Description

Participants will be studied on three separate study days, two days apart: one day for baseline measurements (placebo pill t.i.d), one day for treatment with 10 mg midodrine t.i.d (standard of care), and one day for treatment with the automated abdominal binder combined with placebo pill t.i.d The automated abdominal binder will be placed during the morning orthostatic trial on the active/sham binder study day. The binder will inflate automatically (~40 mmHg) every time the participant stands up throughout the study day.

Participants will be studied on three separate study days, two days apart: one day for baseline measurements (placebo pill t.i.d), one day for treatment with 10 mg midodrine t.i.d (standard of care), and one day for treatment with the sham binder combined with placebo pill t.i.d. The sham binder will be placed during the morning orthostatic trial on the active/sham binder study day. The sham binder will inflate automatically (~5 mmHg) every time the participant stands up throughout the study day.

Outcomes

Primary Outcome Measures

Orthostatic tolerance

orthostatic tolerance is defined as the area under the curve of the upright systolic blood pressure (AUCSBP) during the Morning Orthostatic Trials

Orthostatic Hypotension Symptom Assessment (OHSA) Score

The Orthostatic Hypotension Symptom Assessment (OHSA) Score is the part I of the Orthostatic Hypotension Questionnaire (OHQ). It consists of six questions, each rating the intensity of one characteristic symptom of orthostatic hypotension: 1. Dizziness, lightheadedness, feeling faint, or feeling like you might black out; 2. Problems with vision (blurring, seeing spots, tunnel vision, etc.); 3. Generalized weakness; 4. Fatigue; 5. Trouble concentrating; and 6. Head/neck discomfort.The items are scored on an 11-point Likert scale from 0 to 10, with 0 indicating no symptoms and 10 indicating the worst possible symptoms. Composite score is the average of the item scores obtained at the post-intervention stand period during the Morning Orthostatic Trials

Secondary Outcome Measures

Upright time

Sum of standing and walking times

Full Information

NCT ID

NCT03482297

First Posted

March 22, 2018

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

NCT03482297

Brief Title

Automated Abdominal Binder for Orthostatic Hypotension

Official Title

Randomized, Double-blind, Sham-controlled to Evaluate the Effects of an Automated Abdominal Binder in Improving Orthostatic Tolerance in Autonomic Failure Patients With Disabling Orthostatic Hypotension

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 1, 2018 (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

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The automated inflatable abdominal binder is an investigational device for the treatment of orthostatic hypotension (low blood pressure on standing) in patients with autonomic failure. The purpose of this study is to determine safety and effectiveness of the automated abdominal binder in improving orthostatic tolerance in these patients.

Detailed Description

This is a randomized, double-blind, sham-controlled, parallel group study to compare the efficacy of the automated abdominal binder (inflated to 40 mm Hg) versus sham treatment (abdominal binder inflated to 5 mm Hg) in improving orthostatic tolerance in patients with primary autonomic failure disabled by orthostatic hypotension. Potential participants will be admitted to the Vanderbilt Clinical Research Center for evaluation of inclusion and exclusion criteria. Eligible patients will be randomized to the active or sham binder group. Patients will then be asked to participate on three separate study days, two days apart: one day for baseline measurements (placebo pill t.i.d), one day for treatment with 10 mg midodrine t.i.d (standard of care), and one day for treatment with active or sham binder combined with placebo pill t.i.d. The order of the study days will be randomized. On each study day, blood pressure and heart rate will be measured while sitting, lying down, standing and walking during the Morning Orthostatic Trial, and posture and walking tests.

6. Conditions and Keywords

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

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

Keywords

orthostatic hypotension, abdominal binder, pure autonomic failure, multiple system atrophy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Randomized, double-blind, sham-controlled, parallel-group, 3-study days inpatient study to compare the efficacy of the automated abdominal binder versus sham treatment in improving orthostatic tolerance in patients with primary autonomic failure disabled by neurogenic orthostatic hypotension.

Masking

ParticipantInvestigator

Masking Description

Patients and investigators will be blinded as to the experimental interventions (active or sham abdominal binder, and placebo or midodrine pills)

Allocation

Randomized

Enrollment

31 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Automated Abdominal Binder

Arm Type

Experimental

Arm Description

Arm Title

Sham binder

Arm Type

Sham Comparator

Arm Description

Participants will be studied on three separate study days, two days apart: one day for baseline measurements (placebo pill t.i.d), one day for treatment with 10 mg midodrine t.i.d (standard of care), and one day for treatment with the sham binder combined with placebo pill t.i.d. The sham binder will be placed during the morning orthostatic trial on the active/sham binder study day. The sham binder will inflate automatically (~5 mmHg) every time the participant stands up throughout the study day.

Intervention Type

Device

Intervention Name(s)

automated abdominal binder

Intervention Description

The binder automatically inflates every time the participant stands up to apply a compression level of about 40 mmHg. Participants will wear the device throughout the active/sham study day.

Intervention Type

Device

Intervention Name(s)

Sham binder

Intervention Description

The binder automatically inflates every time the participant stands up to apply a compression level of about 5 mmHg. Participants will wear the device throughout the active/sham study day.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Oral placebo will be given three times a day on the baseline day (placebo)

Intervention Type

Drug

Intervention Name(s)

Midodrine

Intervention Description

A midodrine pill 10mg will be given three times a day on the standard of care study day

Primary Outcome Measure Information:

Title

Orthostatic tolerance

Description

orthostatic tolerance is defined as the area under the curve of the upright systolic blood pressure (AUCSBP) during the Morning Orthostatic Trials

Time Frame

After 10 minutes of standing (or as tolerated) during the Morning orthostatic trial on the automated binder/sham study day

Title

Orthostatic Hypotension Symptom Assessment (OHSA) Score

Description

Time Frame

After 10 minutes of standing (or as tolerated) during the Morning orthostatic trial on the automated binder/sham study day

Secondary Outcome Measure Information:

Title

Upright time

Description

Sum of standing and walking times

Time Frame

After 10 minutes of standing and 15 minutes waking (as tolerated)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male and female subjects, age 40-80 years. Possible or probable Multiple Systems Atrophy and Pure Autonomic Failure as defined by Consensus Criteria. Neurogenic orthostatic hypotension defined as a ≥30-mm Hg decrease in SBP within 3 minutes of standing associated with impaired autonomic reflexes determined by autonomic testing in the absence of other identifiable causes, and Moderate to severe orthostatic symptoms, defined as an Orthostatic Hypotension Symptom Assessment (OHSA) composite score ≥4 (self-rating Likert scale of 0 to 10, with 0 reflecting absence of symptoms), within the first 10 minutes of the screening orthostatic stress test, and that have an impact in quality of life, as defined by the patient. Able and willing to provide informed consent. Exclusion Criteria: Pregnancy. Systemic illnesses known to produce autonomic neuropathy, including but not limited to diabetes mellitus, amyloidosis, monoclonal gammopathies, and autoimmune neuropathies. History of known aortic aneurisms, thoracic, abdominal or pelvic surgery in the past 6 months; symptomatic abdominal or inguinal hernias; severe gastroesophageal reflux; recent fractures or fissures of ribs, thoracic or lumbar spine; medical devices implanted on the abdominal wall or abdomen that would interfere with the binder; known abdominal or pelvic tumors, cysts or enlarged spleen; intolerance to any increase in intraabdominal pressure. Pre-existing sustained supine hypertension ≥180/110. Bedridden patients or those who are unable to stand due to motor impairment or severe orthostatic hypotension. Clinically unstable coronary artery disease (recurrent angina despite medical therapy), or major cardiovascular or neurological event in the past 6 months (myocardial infarction, stroke or transient ischemic attacks). Concomitant use of anticoagulants

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

Luis Okamoto, MD

Phone

615-936-6119

autonomics@vumc.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Italo Biaggioni, MD

Organizational Affiliation

Professor of Medicine and Pharmacology

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Luis E Okamoto, MD

Organizational Affiliation

Research Assistant Professor

Official's Role

Principal Investigator

Facility Information:

Facility Name

Autonomic Dysfunction Center/ Vanderbilt University Medical Center

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

Luis Okamoto, MD

Phone

615-936-6119

autonomics@vumc.org

First Name & Middle Initial & Last Name & Degree

Andre Diedrich, MD PhD

Phone

615-936-0454

autonomics@vumc.org

First Name & Middle Initial & Last Name & Degree

Bonnie K Black, RN

First Name & Middle Initial & Last Name & Degree

Luis E Okamoto, MD

First Name & Middle Initial & Last Name & Degree

Italo Biaggioni, MD

First Name & Middle Initial & Last Name & Degree

Andre Diedrich, MD, PhD

First Name & Middle Initial & Last Name & Degree

Emily C Smith, RN

First Name & Middle Initial & Last Name & Degree

Alfredo Gamboa, MD

12. IPD Sharing Statement

Plan to Share IPD

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Automated Abdominal Binder for Orthostatic Hypotension

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