Effect of Midodrine vs Abdominal Compression on Cardiovascular Risk Markers in Autonomic Failure Patients

Who is this study for? Patients with Pure Autonomic Failure, Multiple System Atrophy
Status: Recruiting
Location: See location...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

The purpose of this study is to learn more about the effects of abdominal compression and the medication midodrine, two interventions used for the treatment of orthostatic hypotension (low blood pressure on standing), on hemodynamic markers of cardiovascular risk. The study will be conducted at the Vanderbilt University Medical Center and consists of a screening and 2 testing days, one with abdominal compression and one with midodrine. The total length of the study will be about 5 days.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 80
Healthy Volunteers: f
View:

• Male and female subjects, age 40-80 years, with autonomic failure including pure autonomic failure, multiple system atrophy and Parkinson disease.

• Neurogenic orthostatic hypotension, defined as a ≥20-mmHg decrease in SBP within 3 minutes of standing associated with impaired autonomic reflexes determined by autonomic testing in the absence of other identifiable causes.

• Patients who are willing and able to provide informed consent

Locations
United States
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Contact Information
Primary
Bonnie K Black, RN
bonnie.black@vumc.org
615-343-6862
Backup
Luis Okamoto, MD
luis.e.okamoto@vumc.org
615-936-6119
Time Frame
Start Date: 2020-11-09
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 31
Treatments
Active_comparator: Midodrine
Single oral dose of midodrine (5-10mg) combined with sham abdominal compression
Experimental: Abdominal Compression
Abdominal compression (up to 40 mmHg) combined with a placebo pill
Sponsors
Leads: Vanderbilt University Medical Center
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

This content was sourced from clinicaltrials.gov

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