RECRUITING

Hemodynamic Mechanisms of Abdominal Compression in the Treatment of Orthostatic Hypotension in Autonomic Failure

Conditions

Orthostatic Hypotension Pure Autonomic Failure Multiple System Atrophy Autonomic Failure compression garments treatment

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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

Compression garments have been shown to be effective in the treatment of orthostatic hypotension in autonomic failure patients. The purpose of this study is to determine the hemodynamic mechanisms by which abdominal compression (up to 40 mm Hg) improve the standing blood pressure and orthostatic tolerance in these patients, and to compare them with those of the standard of care midodrine. The investigators will test the hypothesis that abdominal compression will blunt the exaggerated fall in stroke volume and the increase in abdominal vascular volume during head up tilt.

Official Title

Hemodynamic Mechanisms of Abdominal Compression in the Treatment of Orthostatic Hypotension in Autonomic Failure

Quick Facts

Study Start:2015-04

Study Completion:2025-12-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT02429557

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:18 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 patients, * between 18-80 yrs., * with neurogenic orthostatic hypotension associated with primary autonomic failure (Parkinson Disease, Multiple System Atrophy and Pure Autonomic Failure). Orthostatic hypotension will be defined as ≥20 mmHg decrease in systolic BP or ≥10 mmHg of diastolic BP within 3 minutes on standing associated with impaired autonomic reflexes determined by autonomic testing in the absence of other identifiable causes (Freeman et al., 2011). * Patients able and willing to provide informed consent.	* Pregnancy. * Significant cardiac, renal or hepatic illness, or with contraindications to administration of pressor agents or external abdominal compression will be excluded. * Clinically unstable coronary artery disease, or major cardiovascular or neurological event in the past 6 months, and; other factors which in the investigator's opinion would prevent the subject from completing the protocol including clinically significant abnormalities in clinical, mental or laboratory testing

Inclusion Criteria

Exclusion Criteria

* Male and female patients,
* between 18-80 yrs.,
* with neurogenic orthostatic hypotension associated with primary autonomic failure (Parkinson Disease, Multiple System Atrophy and Pure Autonomic Failure). Orthostatic hypotension will be defined as ≥20 mmHg decrease in systolic BP or ≥10 mmHg of diastolic BP within 3 minutes on standing associated with impaired autonomic reflexes determined by autonomic testing in the absence of other identifiable causes (Freeman et al., 2011).
* Patients able and willing to provide informed consent.

* Pregnancy.
* Significant cardiac, renal or hepatic illness, or with contraindications to administration of pressor agents or external abdominal compression will be excluded.
* Clinically unstable coronary artery disease, or major cardiovascular or neurological event in the past 6 months, and; other factors which in the investigator's opinion would prevent the subject from completing the protocol including clinically significant abnormalities in clinical, mental or laboratory testing

Contacts and Locations

Study Contact

Bonnie K Black, RN

CONTACT

615-343-6862

autonomics@vumc.org

Luis E. Okamoto, MD

CONTACT

(615) 936-6119

luis.e.okamoto@vumc.org

Principal Investigator

Italo Biaggioni, MD

PRINCIPAL_INVESTIGATOR

Vanderbilt University

Luis E Okamoto, MD

PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Study Locations (Sites)

Vanderbilt University

Nashville, Tennessee, 37232

United States

Collaborators and Investigators

Sponsor: Vanderbilt University Medical Center

Italo Biaggioni, MD, PRINCIPAL_INVESTIGATOR, Vanderbilt University
Luis E Okamoto, MD, PRINCIPAL_INVESTIGATOR, Vanderbilt University Medical Center

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 Date2015-04

Study Completion Date2025-12-01

Study Record Updates

Study Start Date2015-04

Study Completion Date2025-12-01

Terms related to this study

Keywords Provided by Researchers

autonomic failure
orthostatic hypotension
compression garments
treatment

Additional Relevant MeSH Terms

Orthostatic Hypotension
Pure Autonomic Failure
Multiple System Atrophy
Autonomic Failure