Clinical trial NCT03482297: 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
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Orthostatic Hypotension
Autonomic Failure
Pure Autonomic Failure
Multiple System Atrophy
Keywords: orthostatic hypotension
abdominal binder
pure autonomic failure
multiple system atrophy
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2018-03-29
Enrollment: 31
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Orthostatic tolerance
timeFrame: After 10 minutes of standing (or as tolerated) during the Morning orthostatic trial on the automated binder/sham study day
measure: Orthostatic Hypotension Symptom Assessment (OHSA) Score
timeFrame: After 10 minutes of standing (or as tolerated) during the Morning orthostatic trial on the automated binder/sham study day
Secondary outcomes:
measure: Upright time
timeFrame: After 10 minutes of standing and 15 minutes waking (as tolerated)
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Autonomic Dysfunction Center/ Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Professor of Medicine and Pharmacology
name: Italo Biaggioni, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Research Assistant Professor
name: Luis E Okamoto, MD
role: PRINCIPAL_INVESTIGATOR
References: