Automated Abdominal Binder for Orthostatic Hypotension

Multiple System Atrophy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03482297
• Other study ID #: 151008
• Secondary ID: 1R01HL144568-01A
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: March 1, 2018
• Est. completion date: December 1, 2024

Study information

• Verified date: March 2024
• Source: Vanderbilt University Medical Center
• Contact: Bonnie K Black, RN
• Phone: 615-343-6862
• Email: autonomics[@]vumc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 31
• Est. completion date: December 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Autonomic Failure
• Hypotension
• Hypotension, Orthostatic
• Multiple System Atrophy
• Orthostatic Hypotension
• Pure Autonomic Failure
• Shy-Drager Syndrome

Intervention

Device:
• automated abdominal binder
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.
• Sham binder
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.

Drug:
• Placebo
Oral placebo will be given three times a day on the baseline day (placebo)
• Midodrine
A midodrine pill 10mg will be given three times a day on the standard of care study day

Locations

Country	Name	City	State
United States	Autonomic Dysfunction Center/ Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Orthostatic tolerance	orthostatic tolerance is defined as the area under the curve of the upright systolic blood pressure (AUCSBP) during the Morning Orthostatic Trials	After 10 minutes of standing (or as tolerated) during the Morning orthostatic trial on the automated binder/sham study day
Primary	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	After 10 minutes of standing (or as tolerated) during the Morning orthostatic trial on the automated binder/sham study day
Secondary	Upright time	Sum of standing and walking times	After 10 minutes of standing and 15 minutes waking (as tolerated)