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Search / Trial NCT02429557

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

Launched by VANDERBILT UNIVERSITY MEDICAL CENTER · Apr 23, 2015

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Autonomic Failure Orthostatic Hypotension Compression Garments Treatment

ClinConnect Summary

This clinical trial is studying how wearing special compression garments on the abdomen can help improve blood pressure and reduce symptoms in patients with a condition called orthostatic hypotension, which is when blood pressure drops significantly when standing up. The researchers want to find out how this abdominal compression affects blood flow and blood volume in the body when someone stands up, and they will compare these results with a commonly used medication called midodrine.

To be eligible for this study, participants need to be between 18 and 80 years old and diagnosed with a specific type of orthostatic hypotension caused by conditions like Parkinson's disease or Multiple System Atrophy. Patients should not have certain serious health issues, such as significant heart or kidney problems, and they should be able to give their consent to participate. If you join this study, you will wear these compression garments during the trial and undergo tests to see how your body responds to them compared to standard treatment. This research could help improve treatment options for people dealing with similar health challenges in the future.

Gender

ALL

Eligibility criteria

  • Inclusion 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.
  • Exclusion Criteria:
  • 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

About Vanderbilt University Medical Center

Vanderbilt University Medical Center (VUMC) is a leading academic medical center located in Nashville, Tennessee, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As a prominent sponsor of clinical trials, VUMC integrates cutting-edge scientific inquiry with patient-centered care, supporting a diverse array of studies aimed at enhancing medical knowledge and improving treatment outcomes. With a robust infrastructure and a multidisciplinary team of experts, VUMC fosters collaboration across various fields, ensuring the highest standards of safety and ethical considerations in its research endeavors. Through its dedication to medical discovery and education, VUMC plays a pivotal role in shaping the future of medicine.

Locations

Nashville, Tennessee, United States

Patients applied

0 patients applied

Trial Officials

Italo Biaggioni, MD

Principal Investigator

Vanderbilt University

Luis E Okamoto, MD

Principal Investigator

Vanderbilt University Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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