Automated Abdominal Binder for Orthostatic Hypotension

Launched by VANDERBILT UNIVERSITY MEDICAL CENTER · Mar 27, 2018

Keywords

ClinConnect Summary

This clinical trial is looking at a new device called an automated abdominal binder, which is designed to help people with orthostatic hypotension—a condition where blood pressure drops significantly when standing up, leading to symptoms like dizziness or fainting. The trial aims to find out if this device is safe and effective in helping patients with certain conditions, such as Multiple System Atrophy and Pure Autonomic Failure, improve their ability to stand without experiencing these troubling symptoms.

To be eligible for the study, participants should be between 40 and 80 years old and have a diagnosis of the mentioned conditions, along with experiencing significant symptoms related to low blood pressure when standing. Those who are pregnant, have certain medical conditions, or have had recent surgeries may not be able to participate. If you join the trial, you’ll be part of a research effort to see how well this device works, and you'll receive close monitoring and support throughout the process. Your involvement could help improve treatments for others facing similar challenges in the future!

Gender

ALL

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