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Abdominal Compression for Orthostatic Hypotension

Phase 1

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

Male and female patients, between 18-80 yrs., with neurogenic orthostatic hypotension associated with primary autonomic failure (Parkinson Disease, Multiple System Atrophy and Pure Autonomic Failure).

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up an average of 15 minutes of head up tilt

Awards & highlights

Study Summary

This trial will help determine how compression garments help autonomic failure patients with orthostatic hypotension by testing how well they improve blood pressure and tolerance to standing up.

Who is the study for?

This trial is for adults aged 18-80 with neurogenic orthostatic hypotension due to autonomic failure (like Parkinson's or Multiple System Atrophy). Participants must have a significant drop in blood pressure upon standing. Pregnant individuals, those with major heart, liver, kidney issues, recent severe cardiovascular events, or conditions that could interfere with the study can't join.Check my eligibility

What is being tested?

The study tests how abdominal compression up to 40 mm Hg helps improve blood pressure and tolerance to being upright compared to a placebo and midodrine (a standard treatment). It aims to understand if this method prevents the usual decrease in blood volume within the heart when patients stand up.See study design

What are the potential side effects?

Potential side effects may include discomfort from wearing tight garments and possible adverse reactions similar to those of midodrine such as scalp tingling, itching skin or urinary urgency.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18-80 years old with low blood pressure due to Parkinson's, MSA, or PAF.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ an average of 15 minutes of head up tilt

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~an average of 15 minutes of head up tilt

This trial's timeline: 3 weeks for screening, Varies for treatment, and an average of 15 minutes of head up tilt for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Stroke volume

Secondary outcome measures

Splanchnic vascular volume

Systolic blood pressure

Side effects data

From 1999 Phase 4 trial • 140 Patients • NCT00046475

Pruritus NOS

Urinary tract infection NOS

Headache NOS

Dizziness

Paraesthesia

Colitis NOS

Cardiac arrest

Hypertension NOS

Injury NOS

Parkinson's disease NOS

Orthostatic hypotension

Gastrointestinal haemorrhage NOS

Syncope

100%

80%

60%

40%

20%

Study treatment Arm

Follow-up

Screening/Washout

Titration

Midodrine HCl

Placebo

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Abdominal compression and placebo pillExperimental Treatment2 Interventions

Abdominal compression with an inflatable abdominal binder (up to 40 mmHg) during head up tilt, and placebo pill given 1 hour before the second head up tilt

Group II: Abdominal compression and midodrineExperimental Treatment2 Interventions

Abdominal compression with an inflatable abdominal binder (up to 40 mmHg) during head up tilt, and midodrine 2.5-10 mg PO given 1 hour before the second head up tilt

Group III: Sham abdominal compression and midodrineActive Control2 Interventions

Sham abdominal compression with an inflatable abdominal binder (~5 mmHg) during head up tilt, and midodrine 2.5-10mg PO given 1 hour before the second head up tilt

Group IV: Sham abdominal compression and placeboPlacebo Group2 Interventions

Sham abdominal compression with an inflatable abdominal binder (~5 mmHg) during head up tilt, and placebo pill given 1 hour before the second head up tilt

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo pill

2016

Completed Phase 4

~970

midodrine

2016

N/A

~80

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor

857 Previous Clinical Trials

672,164 Total Patients Enrolled

9 Trials studying Multiple System Atrophy

301 Patients Enrolled for Multiple System Atrophy

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,838 Previous Clinical Trials

47,851,625 Total Patients Enrolled

4 Trials studying Multiple System Atrophy

156 Patients Enrolled for Multiple System Atrophy

Italo Biaggioni, MDPrincipal InvestigatorVanderbilt University

28 Previous Clinical Trials

1,425 Total Patients Enrolled

12 Trials studying Multiple System Atrophy

418 Patients Enrolled for Multiple System Atrophy

Media Library

Abdominal compression Clinical Trial Eligibility Overview. Trial Name: NCT02429557 — Phase 1

Multiple System Atrophy Research Study Groups: Abdominal compression and placebo pill, Sham abdominal compression and placebo, Abdominal compression and midodrine, Sham abdominal compression and midodrine

Multiple System Atrophy Clinical Trial 2023: Abdominal compression Highlights & Side Effects. Trial Name: NCT02429557 — Phase 1

Abdominal compression 2023 Treatment Timeline for Medical Study. Trial Name: NCT02429557 — Phase 1

Frequently Asked Questions

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

Is this research endeavor still enrolling participants?

"Affirmative. According to the information posted on clinicaltrials.gov, enrolment for this medical trial is open at present. The experiment was initiated on April 1st 2015 and last updated on August 20th 2022 with the objective of enrolling 29 participants from a single location."

Answered by AI

To what extent has recruitment for this trial been successful?

"Affirmative, clinicaltrials.gov data suggests that this medical experiment is still recruiting volunteers since it first appeared on April 1st 2015 and was recently updated on August 20th 2022. 29 participants are required from a single location to complete the trial."

Answered by AI

Does this trial include individuals of a younger age bracket?

"According to the recruitment guidelines, this medical trial is open to those aged between 18 and 80. There are 50 trials targeting individuals younger than 18 years of age and 241 for seniors over 65."

Answered by AI

Does Abdominal compression pose any risks to individuals?

"The safety of abdominal compression has yet to be established, as this is a Phase 1 trial. Therefore, our team at Power assessed it with the lowest possible score of 1 out of 3."

Answered by AI

Who qualifies to join this medical experiment?

"This trial is looking for 29 participants that suffer from pure autonomic failure and are aged between 18 to 80. To be considered, potential volunteers must fit into the specified age range, regardless of gender."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Hemodynamic Mechanisms of Abdominal Compression in the Treatment of Orthostatic Hypotension in Autonomic Failure

Luis E Okamoto 2015. "Hemodynamic Mechanisms of Abdominal Compression in the Treatment of Orthostatic Hypotension in Autonomic Failure". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02429557.

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