Your session is about to expire
← Back to Search
Device
Automated Abdominal Binder for Orthostatic Hypotension
Phase 1 & 2
Recruiting
Led By Italo Biaggioni, 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 ≥30-mm Hg decrease in SBP within 3 minutes of standing associated with impaired autonomic reflexes determined by autonomic testing in the absence of other identifiable causes,
Moderate to severe orthostatic symptoms, defined as an Orthostatic Hypotension Symptom Assessment (OHSA) composite score ≥4 (self-rating Likert scale of 0 to 10, with 0 reflecting absence of symptoms), within the first 10 minutes of the screening orthostatic stress test, and that have an impact in quality of life, as defined by the patient.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after 10 minutes of standing and 15 minutes waking (as tolerated)
Awards & highlights
Study Summary
This trial is testing a device to help people with low blood pressure when standing up. The device is an abdominal binder that inflates automatically. The trial will test how well the device works and if it is safe.
Who is the study for?
This trial is for adults aged 40-80 with Multiple System Atrophy or Pure Autonomic Failure, who experience significant drops in blood pressure upon standing and have related symptoms impacting their quality of life. Pregnant individuals, those with certain systemic illnesses, recent surgery patients, and people on anticoagulants cannot participate.Check my eligibility
What is being tested?
The study tests an automated abdominal binder against a sham binder to see if it helps manage low blood pressure when standing due to autonomic failure. Participants may also receive Midodrine (a drug for low blood pressure) or placebo as part of the trial.See study design
What are the potential side effects?
Potential side effects could include discomfort from the binder's pressure, skin irritation where the device is worn, and typical reactions to Midodrine such as scalp tingling, itching, goosebumps, nausea or urinary urgency.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My blood pressure drops significantly when I stand, due to nerve issues.
Select...
I often feel dizzy or faint when standing up, and it affects my daily life.
Select...
I am between 40 and 80 years old.
Select...
I am between 40 and 80 years old.
Select...
My blood pressure drops significantly when I stand, due to nerve issues.
Select...
I experience significant dizziness or lightheadedness when standing, affecting my quality of life.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ after 10 minutes of standing (or as tolerated) during the morning orthostatic trial on the automated binder/sham study day
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after 10 minutes of standing (or as tolerated) during the morning orthostatic trial on the automated binder/sham study day
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Orthostatic Hypotension Symptom Assessment (OHSA) Score
Orthostatic tolerance
Secondary outcome measures
Upright time
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Automated Abdominal BinderExperimental Treatment3 Interventions
Participants will be studied on three separate study days, two days apart: one day for baseline measurements (placebo pill t.i.d), one day for treatment with 10 mg midodrine t.i.d (standard of care), and one day for treatment with the automated abdominal binder combined with placebo pill t.i.d The automated abdominal binder will be placed during the morning orthostatic trial on the active/sham binder study day. The binder will inflate automatically (~40 mmHg) every time the participant stands up throughout the study day.
Group II: Sham binderPlacebo Group3 Interventions
Participants will be studied on three separate study days, two days apart: one day for baseline measurements (placebo pill t.i.d), one day for treatment with 10 mg midodrine t.i.d (standard of care), and one day for treatment with the sham binder combined with placebo pill t.i.d. The sham binder will be placed during the morning orthostatic trial on the active/sham binder study day. The sham binder will inflate automatically (~5 mmHg) every time the participant stands up throughout the study day.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Midodrine
2008
Completed Phase 4
~1160
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
856 Previous Clinical Trials
672,161 Total Patients Enrolled
5 Trials studying Orthostatic Hypotension
123 Patients Enrolled for Orthostatic Hypotension
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,836 Previous Clinical Trials
47,311,081 Total Patients Enrolled
2 Trials studying Orthostatic Hypotension
37 Patients Enrolled for Orthostatic Hypotension
Italo Biaggioni, MDPrincipal InvestigatorProfessor of Medicine and Pharmacology
28 Previous Clinical Trials
1,423 Total Patients Enrolled
4 Trials studying Orthostatic Hypotension
502 Patients Enrolled for Orthostatic Hypotension
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had major surgery, severe hernias, intense acid reflux, recent bone fractures, or devices that could interfere with abdominal pressure in the last 6 months.I am bedridden or cannot stand due to severe mobility issues.My blood pressure drops significantly when I stand, due to nerve issues.I often feel dizzy or faint when standing up, and it affects my daily life.I am between 40 and 80 years old.I haven't had a heart attack, stroke, or severe chest pain in the last 6 months.I am between 40 and 80 years old.I have been diagnosed with Multiple Systems Atrophy or Pure Autonomic Failure.I have a condition like diabetes that affects my nerves.I have been diagnosed with Multiple Systems Atrophy or Pure Autonomic Failure.You have very high blood pressure when lying down.I am currently taking blood thinners.My blood pressure drops significantly when I stand, due to nerve issues.I experience significant dizziness or lightheadedness when standing, affecting my quality of life.
Research Study Groups:
This trial has the following groups:- Group 1: Sham binder
- Group 2: Automated Abdominal Binder
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are recruitment and enrollment still open for this experiment?
"The listed clinical trial on clinicaltrials.gov is still recruiting patients, with the posting date being March 1st, 2018 and the last edit occurring on August 20th, 2022."
Answered by AI
Are elderly people eligible for this trial?
"According to the study's inclusion criteria, patients that enroll must be between 40 and 80 years old. There are 52 trials for people under 18 and 249 for senior citizens."
Answered by AI
Could I be a candidate for participation in this research?
"This trial is looking for 31 patients aged between 40 and 80 who have orthostatic hypotension. In order to be eligible, participants must also satisfy the following conditions: having neurogenic orthostatic hypotension as defined by a ≥30-mm Hg decrease in SBP within 3 minutes of standing associated with impaired autonomic reflexes determined by autonomic testing in the absence of other identifiable causes,, possible or probable Multiple Systems Atrophy and Pure Autonomic Failure as defined by Consensus Criteria., moderate to severe orthostatic symptoms, defined as an Orthostatic Hypotension Symptom Assessment (OHSA) composite"
Answered by AI
What is the maximum number of people that can join this trial?
"That is correct. The clinical trial was posted on March 1st, 2018 and is currently 31 patients short of their goal number, which is hosted across a single site."
Answered by AI
Who else is applying?
What state do they live in?
Utah
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Autonomic Dysfunction Center/ Vanderbilt University Medical Center
Why did patients apply to this trial?
I find my diagnosed OH extremely debilitating, preventing me from doing many normal activities, making me dependent and not adequately treated with midodrine and salt.
PatientReceived 1 prior treatment
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger