Abdominal Compression for Orthostatic Hypotension

Overseen By Luis E. Okamoto, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Pregnancy, Cardiac, Renal, Hepatic, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 2 days

29 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the study involves comparing abdominal compression with the standard medication midodrine, it's possible that you may need to continue or adjust your current treatment. Please consult with the trial coordinators for specific guidance.

What data supports the effectiveness of the treatment Abdominal Compression for Orthostatic Hypotension?

Research shows that using an elastic abdominal binder can help improve blood pressure control in people with orthostatic hypotension, similar to the effects of the drug midodrine. This treatment can reduce symptoms when standing by providing pressure that helps maintain blood flow. ^{1 2 3 4 5}

Is abdominal compression safe for humans?

Abdominal compression, such as using an abdominal binder, is generally safe for humans, but it should be used with caution when lying down for long periods, as it can cause blood to pool in the legs, potentially increasing the risk of blood clots. ^{1 2 3 4 5}

How does the treatment of abdominal compression for orthostatic hypotension differ from other treatments?

Abdominal compression, such as using an elastic abdominal binder or an inflatable bladder, is unique because it directly targets the splanchnic veins in the abdomen to prevent blood pooling when standing, unlike traditional drugs like midodrine that increase blood pressure through other mechanisms. This non-drug approach can be activated only when needed, providing a flexible and immediate response to changes in posture. ^{1 3 5 6 7}

What is the purpose of this trial?

Compression garments have been shown to be effective in the treatment of orthostatic hypotension in autonomic failure patients. The purpose of this study is to determine the hemodynamic mechanisms by which abdominal compression (up to 40 mm Hg) improve the standing blood pressure and orthostatic tolerance in these patients, and to compare them with those of the standard of care midodrine. The investigators will test the hypothesis that abdominal compression will blunt the exaggerated fall in stroke volume and the increase in abdominal vascular volume during head up tilt.

Research Team

Italo Biaggioni, MD

Principal Investigator

Vanderbilt University

Luis E Okamoto, MD

Principal Investigator

Vanderbilt University Medical Center

Eligibility Criteria

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.

Inclusion Criteria

Patients able and willing to provide informed consent.

If your blood pressure drops a lot when you stand up, and it's caused by a problem with your body's reflexes, you can't join the study.

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

Exclusion Criteria

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

Pregnancy.

I haven't had a major heart, brain event, or unstable heart disease in the last 6 months and no health issues that would stop me from completing a study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo head up tilt testing with abdominal compression and sham compression in a randomized, crossover fashion

2 days

2 visits (in-person)

Follow-up

Participants are monitored for changes in systolic blood pressure, splanchnic vascular volume, and stroke volume during head up tilt

4 weeks

Treatment Details

Interventions

• Abdominal compression
• midodrine
• Placebo pill
• Sham abdominal compression

Trial Overview 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.

Participant Groups

Group I: Abdominal compression and placebo pill Experimental Treatment 2 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 midodrine Experimental Treatment 2 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 midodrine Active Control 2 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 placebo Placebo Group 2 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

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Findings from Research

In a study involving 15 patients with Parkinson's disease, the use of an elastic abdominal binder significantly reduced the drop in blood pressure when standing, with an average increase of 10 mm Hg compared to a placebo.

Symptoms of orthostatic hypotension improved significantly during a 4-week follow-up period, indicating that elastic abdominal binders could be an effective complementary treatment for managing this condition in Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Elastic Abdominal Binders Attenuate Orthostatic Hypotension in Parkinson's Disease. Fanciulli, A., Goebel, G., Metzler, B., et al.[2022]

The abdominal compression binder significantly increases venous volume in the lower extremities, leading to reduced stroke volume and cardiac output in 25 healthy subjects, indicating a notable impact on central and peripheral haemodynamics.

While the binder does not affect pulmonary volumes, its use in the supine position for extended periods should be approached with caution due to the potential risk of deep venous thrombosis from blood pooling in the legs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Haemodynamic and respiratory effects of an abdominal compression binder. Toft, MH., Bülow, J., Simonsen, L.[2008]

The automated inflatable abdominal binder provides effective venous compression and improves orthostatic tolerance in patients with autonomic failure, showing similar efficacy to the standard treatment, midodrine, in a study of 19 patients.

Combining the binder with midodrine significantly enhances orthostatic tolerance and reduces symptoms more than either treatment alone, indicating a potential for improved management of orthostatic hypotension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Servo-Controlled Splanchnic Venous Compression in the Treatment of Orthostatic Hypotension: A Randomized Comparison With Midodrine. Okamoto, LE., Diedrich, A., Baudenbacher, FJ., et al.[2018]

In a study of 57 laparotomy patients, those using elastic abdominal binders experienced earlier mobilization after surgery compared to those using non-elastic binders (3.2 days vs. 5.0 days).

The use of non-elastic binders resulted in a significantly greater increase in intra-vesical pressure (IVP) compared to elastic binders, suggesting that elastic binders are safer and more effective for postoperative recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of different types of abdominal binders on intra-abdominal pressure. Zhang, HY., Liu, D., Tang, H., et al.[2018]

This study quantitatively analyzed the effectiveness of inflatable abdominal binders for managing orthostatic hypotension, showing that they can provide consistent pressure across different areas of the abdomen without significant differences in pressure exerted on the body.

The research developed a model that correlates the pressure in the inflatable bladder to the actual pressure experienced by the patient, ensuring safety and effectiveness in treatment, which is crucial for nonpharmacological management of this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of Abdominal Constrictor's Forces for Informing Computational Models of Orthostatic Hypotension. Syed, F., Jose, R., Devine, T., et al.[2022]

The use of Military Anti-Shock Trousers (MAST) in a 49-year-old man with severe anaphylactic hypotension significantly improved his blood pressure and helped stabilize his condition after traditional treatments failed.

MAST may be an effective adjunct treatment for patients experiencing severe hypotension due to anaphylaxis, as it enhances blood flow and pressure when intravenous fluids and epinephrine are insufficient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility of military anti-shock trousers (MAST) in anaphylactic shock--a case report. Granata, AV., Halickman, JF., Borak, J.[2019]

Mild abdominal compression (10mmHg) applied before standing can significantly reduce the drop in systolic blood pressure (SBP) associated with orthostatic hypotension in adults with neurogenic OH, showing a decrease of -50mmHg with a conventional binder and -46mmHg with an adjustable binder.

Increasing abdominal compression beyond mild levels while standing does not provide additional benefits and may worsen symptoms of orthostatic hypotension, indicating that moderate compression is optimal for managing blood pressure changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of patient-controlled abdominal compression on standing systolic blood pressure in adults with orthostatic hypotension. Figueroa, JJ., Singer, W., Sandroni, P., et al.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Elastic Abdominal Binders Attenuate Orthostatic Hypotension in Parkinson's Disease. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Haemodynamic and respiratory effects of an abdominal compression binder. [2008]

3. United States pubmed.ncbi.nlm.nih.gov

Efficacy of Servo-Controlled Splanchnic Venous Compression in the Treatment of Orthostatic Hypotension: A Randomized Comparison With Midodrine. [2018]

4. Saudi Arabia pubmed.ncbi.nlm.nih.gov

The effect of different types of abdominal binders on intra-abdominal pressure. [2018]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Assessment of Abdominal Constrictor's Forces for Informing Computational Models of Orthostatic Hypotension. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Utility of military anti-shock trousers (MAST) in anaphylactic shock--a case report. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Effects of patient-controlled abdominal compression on standing systolic blood pressure in adults with orthostatic hypotension. [2018]