RECRUITING

Automated Abdominal Binder for Orthostatic Hypotension

Conditions

Orthostatic Hypotension Autonomic Failure Pure Autonomic Failure Multiple System Atrophy abdominal binder

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2018-03-01

Study Completion:2025-12-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03482297

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Study Contact

Bonnie K Black, RN

CONTACT

615-343-6862

autonomics@vumc.org

Luis Okamoto, MD

CONTACT

615-936-6119

autonomics@vumc.org

Principal Investigator

Italo Biaggioni, MD

PRINCIPAL_INVESTIGATOR

Professor of Medicine and Pharmacology

Luis E Okamoto, MD

PRINCIPAL_INVESTIGATOR

Research Assistant Professor

Study Locations (Sites)

Autonomic Dysfunction Center/ Vanderbilt University Medical Center

Nashville, Tennessee, 37232

United States

Collaborators and Investigators

Sponsor: Vanderbilt University Medical Center

Italo Biaggioni, MD, PRINCIPAL_INVESTIGATOR, Professor of Medicine and Pharmacology
Luis E Okamoto, MD, PRINCIPAL_INVESTIGATOR, Research Assistant Professor

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-03-01

Study Completion Date2025-12-01

Study Record Updates

Study Start Date2018-03-01

Study Completion Date2025-12-01

Terms related to this study

Keywords Provided by Researchers

orthostatic hypotension
abdominal binder
pure autonomic failure
multiple system atrophy

Additional Relevant MeSH Terms

Orthostatic Hypotension
Autonomic Failure
Pure Autonomic Failure
Multiple System Atrophy