RecruitingEarly Phase 1NCT04620382

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


Sponsor

Vanderbilt University Medical Center

Enrollment

31 participants

Start Date

Nov 9, 2020

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 40 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two treatments — midodrine (a blood pressure-raising medication) and an abdominal compression binder — to see which better helps people with autonomic failure manage the dramatic drop in blood pressure they experience when standing up (called neurogenic orthostatic hypotension). **You may be eligible if...** - You are between 40 and 80 years old - You have been diagnosed with an autonomic failure condition, such as pure autonomic failure, multiple system atrophy, or Parkinson's disease - You experience a significant drop in blood pressure (≥20 mmHg) within 3 minutes of standing - You are willing and able to give informed consent **You may NOT be eligible if...** - You are pregnant - You cannot tolerate an abdominal compression device due to prior abdominal surgery, hernias, severe acid reflux, or rib fractures - You have certain heart or kidney conditions that would make the treatments unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMidodrine

Midodrine 5-10 mg, single oral dose

DRUGPlacebo pill

single oral dose

DEVICEAbdominal compression

abdominal compression up to 40 mmHg during head-up tilt

DEVICEsham compression

Sham abdominal compression during head-up tilt


Locations(1)

Vanderbilt University Medical Center

Nashville, Tennessee, United States

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NCT04620382


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