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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
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
Male and female subjects, age 40-80 years, with autonomic failure including pure autonomic failure, multiple system atrophy and Parkinson disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 hour post-intervention tilt table test
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I experience a significant drop in blood pressure when standing, due to nerve issues.
Select...
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.
Select...
I experience a significant drop in blood pressure when standing, due to nerve issues.
Select...
I am between 40 and 80 years old with a diagnosis of autonomic failure, including conditions like pure autonomic failure, multiple system atrophy, or Parkinson's disease.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hemodynamic markers of cardiovascular risk

Side effects data

From 1999 Phase 4 trial • 140 Patients • NCT00046475
6%
Pruritus NOS
5%
Urinary tract infection NOS
4%
Dizziness
4%
Headache NOS
2%
Paraesthesia
1%
Colitis NOS
1%
Cardiac arrest
1%
Hypertension NOS
1%
Injury NOS
1%
Parkinson's disease NOS
1%
Orthostatic hypotension
1%
Gastrointestinal haemorrhage NOS
1%
Syncope
100%
80%
60%
40%
20%
0%
Study treatment Arm
Follow-up
Screening/Washout
Titration
Midodrine HCl
Placebo

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
2016
Completed Phase 4
~970

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
853 Previous Clinical Trials
671,037 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,820 Previous Clinical Trials
47,299,406 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I meet the qualifications to join this experiment?

"Those hoping to qualify for this trial should have a diagnosis of Parkinson's disease and be aged between 40-80 years old. Currently, the study is looking to recruit 31 patients in total."

Answered by AI

Is this research endeavor open to individuals who are 60 or older?

"This clinical trial is open to adults aged 40-80. For those younger than 18, there are 34 trials available and for persons above 65, 598 options exist."

Answered by AI

How many individuals are participating in the current clinical trial?

"Affirmative. According to clinicaltrials.gov, this research project is currently recruiting participants; it was initially posted on November 9th 2020 and was most recently amended on May 31st 2022. The trial requires a total of 31 applicants from 1 medical centre."

Answered by AI

Is this research seeking participants at the present time?

"Affirmative. According to the information posted on clinicaltrials.gov, this trial is presently recruiting patients with a start date of November 9th 2020 and last update made on May 31st 2022. The research team needs to recruit 31 individuals from 1 location for their study."

Answered by AI

Who else is applying?

What site did they apply to?
Vanderbilt University Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
~3 spots leftby Sep 2024