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Midodrine vs Abdominal Compression for Orthostatic Hypotension

Phase < 1
Recruiting
Led By Luis Okamoto, MD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Must not have
Bedridden patients or those who are unable to stand due to motor impairment or severe OH
Clinically unstable coronary artery disease, or major cardiovascular or neurological event in the past 6 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 hour post-intervention tilt table test
Awards & highlights

Summary

This trial is testing two interventions for low blood pressure when standing up. It will last for five days total, and screen and test participants at Vanderbilt University Medical Center.

Who is the study for?
This trial is for men and women aged 40-80 with autonomic failure conditions like pure autonomic failure, multiple system atrophy, Parkinson's disease, or neurogenic orthostatic hypotension. Participants must experience a significant drop in blood pressure upon standing and be able to give informed consent. Pregnant individuals or those with certain health issues such as severe hypertension, recent surgeries, hernias, gastrointestinal reflux, fractures or implanted medical devices that could interfere with abdominal compression are excluded.
What is being tested?
The study investigates the effects of midodrine (a medication) versus placebo pills and abdominal compression versus sham compression on cardiovascular risk markers in patients with low blood pressure when standing due to autonomic failure. Conducted over approximately five days at Vanderbilt University Medical Center, it includes screening and two testing days for each intervention.
What are the potential side effects?
Midodrine may cause side effects such as scalp tingling, chills goosebumps urinary urgency skin rash itching heart pounding feeling nervousness headache dizziness nausea weakness confusion although not everyone will experience these. Abdominal compression might cause discomfort or exacerbate pre-existing conditions related to the abdomen.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 40-80 years old with a diagnosis of autonomic failure, including conditions like pure autonomic failure, multiple system atrophy, or Parkinson's disease.
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I experience a significant drop in blood pressure when standing, due to nerve issues.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am bedridden or cannot stand due to severe health issues.
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I haven't had a heart attack, stroke, or severe heart disease in the last 6 months.
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I cannot stand for a minute after stopping my medication or have very high blood pressure.
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I cannot have abdominal compression due to certain health issues or recent surgeries.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 hour post-intervention tilt table test
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 hour post-intervention tilt table test for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Hemodynamic markers of cardiovascular risk

Side effects data

From 1999 Phase 4 trial • 140 Patients • NCT00046475
4%
Urinary tract infection NOS
3%
Hypertension NOS
2%
Dizziness
1%
Headache NOS
1%
Orthostatic hypotension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Screening/Washout
Titration
Midodrine HCl
Placebo
Follow-up

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Abdominal CompressionExperimental Treatment2 Interventions
Abdominal compression (up to 40 mmHg) combined with a placebo pill
Group II: MidodrineActive Control2 Interventions
Single oral dose of midodrine (5-10mg) combined with sham abdominal compression
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo pill
2013
Completed Phase 4
~1030

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
888 Previous Clinical Trials
934,903 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,889 Previous Clinical Trials
47,834,176 Total Patients Enrolled
Luis Okamoto, MDPrincipal InvestigatorVanderbilt University Medical Center
1 Previous Clinical Trials
58 Total Patients Enrolled

Media Library

Neurogenic Orthostatic Hypotension Clinical Trial 2023: Abdominal Compression Highlights & Side Effects. Trial Name: NCT04620382 — Phase < 1
~6 spots leftby Sep 2025
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