Abdominal Compression for Orthostatic Hypotension
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: Vanderbilt University Medical Center
Disqualifiers: Pregnancy, Cardiac, Renal, Hepatic, others
No Placebo Group
Trial Summary
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.
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.
12345Is 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.
12345How 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.
13567Eligibility 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.
Trial 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
Participant Groups
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.
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Vanderbilt UniversityNashville, TN
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Who Is Running the Clinical Trial?
Vanderbilt University Medical CenterLead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)Collaborator
References
Elastic Abdominal Binders Attenuate Orthostatic Hypotension in Parkinson's Disease. [2022]To investigate the possible efficacy of an elastic abdominal binder to control orthostatic hypotension (OH) associated with Parkinson's disease (PD), 15 patients with PD and OH were enrolled in a single-blind crossover study with elastic abdominal versus placebo binder on two different days, separated by a 1-day interval, followed by a 4-week open-label follow-up.
Haemodynamic and respiratory effects of an abdominal compression binder. [2008]In order to elucidate the circulatory and respiratory effects of a newly developed abdominal compression binder 25 healthy, normal weight subjects were studied. In supine position the central haemodynamics were measured and estimated with a Finapress device. Lower extremity venous haemodynamics were measured in supine position with venous occlusion plethysmography. In an upright-seated position arterial oxygen saturation was measured by a pulseoxymeter for 1 h before spirometry was performed with a turbine flow measurement device. All the tests were performed in a randomized order with or without the abdominal compression binder. The results show that the compression binder significantly increases the venous volume in the lower extremities as showed by a reduction in the venous capacitance in the lower extremities and a reduction in the stroke volume and cardiac output, while it does not influence the pulmonary volumes. It is concluded that the applied abdominal binder significantly affects peripheral and central haemodynamics. It should therefore be used with caution when in the supine position for longer periods, as the pooling of blood it induces in the lower extremities may have implications for the risk of deep venous thrombosis formation.
Efficacy of Servo-Controlled Splanchnic Venous Compression in the Treatment of Orthostatic Hypotension: A Randomized Comparison With Midodrine. [2018]Splanchnic venous pooling is a major hemodynamic determinant of orthostatic hypotension, but is not specifically targeted by pressor agents, the mainstay of treatment. We developed an automated inflatable abdominal binder that provides sustained servo-controlled venous compression (40 mm Hg) and can be activated only on standing. We tested the efficacy of this device against placebo and compared it to midodrine in 19 autonomic failure patients randomized to receive either placebo, midodrine (2.5-10 mg), or placebo combined with binder on separate days in a single-blind, crossover study. Systolic blood pressure (SBP) was measured seated and standing before and 1-hour post medication; the binder was inflated immediately before standing. Only midodrine increased seated SBP (31±5 versus 9±4 placebo and 7±5 binder, P=0.003), whereas orthostatic tolerance (defined as area under the curve of upright SBP [AUCSBP]) improved similarly with binder and midodrine (AUCSBP, 195±35 and 197±41 versus 19±38 mm Hg×minute for placebo; P=0.003). Orthostatic symptom burden decreased with the binder (from 21.9±3.6 to 16.3±3.1, P=0.032) and midodrine (from 25.6±3.4 to 14.2±3.3, P
The effect of different types of abdominal binders on intra-abdominal pressure. [2018]To investigate the effect of non-elastic/elastic abdominal binders on intra-vesical pressure (IVP), physiological functions, and clinical outcomes in laparotomy patients at the perioperative stage.
Assessment of Abdominal Constrictor's Forces for Informing Computational Models of Orthostatic Hypotension. [2022]Orthostatic hypotension is defined as a sudden drop in blood pressure upon standing from a sitting or supine position. The prevalence of this condition increases exponentially with age. Nonpharmacological treatments are always the first step in the management of this condition, such as the use of an abdominal constriction belt to optimize the blood volume in the abdomen. A multitude of clinical trials have shown the efficacy of elastic abdominal compression as well as compression using an inflatable bladder; however, there are currently few accessible consumer products that can provide abdominal compression by using an inflatable bladder that ensures the correct amount of pressure is being exerted on the subject. This study serves to quantitatively analyze forces exerted in inflatable abdominal binders, a novel treatment that fits the criterion for a first-line intervention for orthostatic hypotension. Quantitative values aim to indicate both the anatomic regions of the body subjected to the highest pressure by abdominal binding. Quantitative values will also create a model that can correlate the amount of compression on the subject with varying levels of pressure in the inflatable bladder. Inflatable binders of varying levels of inflation are used and localized pressure values are recorded at 5 different vertical points along the abdomen in the midsternal line and midclavicular line, at the locations of the splanchnic veins. These findings indicate both the differences in the compressive force applied through elastic and inflatable binding, as well the regions on the abdomen subject to the highest force load during compression by an abdominal binder. A medical manikin called the iStan Manikin was used to collect data. The pressure values on a manikin were sensed by the JUZO pressure monitor, a special device created for the purpose of measuring the force under compressive garments. The pressure inside the inflatable bladder was extrapolated from a pressure gauge and the pressure was recorded at different degrees of inflation of the belt (mmHG) along two different areas of the abdomen, the midsternal line and the midclavicular line, to discern differences in force exerted on the patient (mmHG). Computational studies on the data from the JUZO pressure monitor as well as the data from the pressure gauge on the inflatable bladder allow us to create a model that can correlate the amount of pressure in the inflatable bladder to the amount of pressure exerted on the belt, thus making sure that the patient is not being harmed by the compressive force. The results of our study indicate that there is no significant difference between the pressures exerted on the midsternal and midclavicular lines of the body by the abdominal binder and that no significant difference exists between the external pressure measured by the inflatable belt and the pressure sensed on the human body by the JUZO sensor; however, we were able to extrapolate an equation that can tell the user the amount of pressure that is actually being exerted on them based on the pressure in the inflatable bladder as recorded by the gauge.
Utility of military anti-shock trousers (MAST) in anaphylactic shock--a case report. [2019]A 49-year-old man with severe anaphylactic hypotension deteriorated and developed an unmeasurable blood pressure despite vigorous intravenous (IV) fluid and epinephrine administration. Application of the lower body compression garment known as MAST (Military Anti-Shock Trousers) improved the patient's blood pressure and helped to stabilize it until additional fluids and vasopressors were administered; he survived without sequellae. We propose that augmentation of preload and afterload by MAST is a useful adjunct in severely hypotensive anaphylactic patients who do not respond initially to IV fluids and epinephrine.
Effects of patient-controlled abdominal compression on standing systolic blood pressure in adults with orthostatic hypotension. [2018]To assess the effects of patient-controlled abdominal compression on postural changes in systolic blood pressure (SBP) associated with orthostatic hypotension (OH). Secondary variables included subject assessments of their preferences and the ease-of-use.