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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

Must not have

Significant cardiac, renal or hepatic illness, or with contraindications to administration of pressor agents or external abdominal compression will be excluded.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up an average of 15 minutes of head up tilt

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have serious heart, kidney, or liver disease, and I can receive certain medications and treatments.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Stroke volume

Secondary study objectives

Splanchnic vascular volume

Systolic blood pressure

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

2013

Completed Phase 4

~1030

midodrine

2016

N/A

~80