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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of abdominal compression garments for individuals with orthostatic hypotension, a condition where blood pressure drops upon standing, causing dizziness or fainting. The trial compares compression garments with the medication midodrine to determine which better supports blood pressure when standing. Participants will try different combinations of garments and pills to identify the most effective approach. Individuals with conditions like Parkinson's disease who frequently experience dizziness upon standing might be suitable for this study. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this innovative approach.

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 prior data suggests that abdominal compression is safe for treating orthostatic hypotension?

Research has shown that using an inflatable abdominal binder to treat orthostatic hypotension (a condition where blood pressure drops when standing up) is safe. Studies have found that these binders help improve blood pressure when standing. Blood pressure did not significantly change when lying down, indicating that the treatment was well-tolerated without major issues.

Midodrine, another treatment being compared, already has FDA approval for orthostatic hypotension. It effectively improves standing blood pressure. Some people have reported side effects, but these are generally manageable.

Both treatments are generally considered safe for humans based on past research and existing approvals. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about exploring abdominal compression for orthostatic hypotension because it offers a mechanical approach to managing blood pressure, distinct from traditional medication-based treatments like fludrocortisone or midodrine alone. This method uses an inflatable abdominal binder to apply pressure, potentially stabilizing blood flow when a person stands up, a key issue in orthostatic hypotension. By combining it with or comparing it to midodrine, researchers aim to uncover if this approach can enhance treatment efficacy, providing a non-pharmacological option or a complementary therapy to existing drugs.

What evidence suggests that this trial's treatments could be effective for orthostatic hypotension?

This trial will evaluate different treatments for orthostatic hypotension. Research has shown that wearing an abdominal binder, which participants in this trial may receive, can help individuals remain upright without dizziness or fainting by reducing the drop in blood pressure when standing. This is particularly beneficial for those with orthostatic hypotension, a condition where blood pressure decreases upon standing.

Regarding midodrine, another treatment option in this trial, larger studies have found it safe and effective for treating orthostatic hypotension. In clinical trials, midodrine raised blood pressure when standing and reduced symptoms like dizziness, making it a reliable option for managing the condition. ^{2 3 5 6 7}

Who Is on the Research Team?

Italo Biaggioni, MD

Principal Investigator

Vanderbilt University

Luis E Okamoto, MD

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6178725/

Elastic Abdominal Binders Attenuate Orthostatic ... No significant change of supine mean BP was observed with the abdominal binder compared to placebo; the difference was +4.8 mm Hg (±15.3; −4.9, +14.5; P = 0.3).

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4339489/

Effects of Patient-Controlled Abdominal Compression on ... The degree of abdominal compression achieved by the subjects during upright adjustment was higher with a pullstring binder than an elastic binder both at the ...

3. mdpi.com mdpi.com/2039-7283/14/5/138

A Safety-Centric Study on the Use of Inflatable Abdominal ... The results showed that the use of an elastic abdominal binder was associated with improved orthostatic tolerance in PD patients with OH. A ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT01223391

Abdominal Compression in Orthostatic Hypotension The purpose of this study is to assess if abdominal binders that use pull strings to adjust compression (non-elastic) are more effective than ...

5. movementdisorders.onlinelibrary.wiley.com movementdisorders.onlinelibrary.wiley.com/doi/am-pdf/10.1002/mdc3.12270

Elastic Abdominal Binders Attenuate Orthostatic ... Results: Intervention significantly reduced blood pressure fall upon tilting. The mean difference. (standard deviation; 95% confidence intervals) ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11417920/

A Safety-Centric Study on the Use of Inflatable Abdominal ... The results showed that the use of an elastic abdominal binder was associated with improved orthostatic tolerance in PD patients with OH.

7. ahajournals.org ahajournals.org/doi/pdf/10.1161/HYPERTENSIONAHA.116.07199

Orthostatic Hypotension Our results indicate that the automated abdominal binder improved standing BP and reduced orthostatic symp- toms in a magnitude similar to that of midodrine, ...