Abdominal Compression in Orthostatic Hypotension

Completed · Not applicable

Conditions studied: Autonomic Failure, Orthostatic Hypotension

In brief

The purpose of this study is to assess if abdominal binders that use pull strings to adjust compression (non-elastic) are more effective than standard elastic abdominal binders in attenuating neurogenic orthostatic hypotension.

Key facts

Study ID

NCT01223391

Run by

Mayo Clinic

People needed

13

Starts

2010-10-01

Expected to finish

2012-08-01

Last updated by the study team

2014-05-12

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and nonpregnant women aged 18-80 years.
• Chronic neurologic conditions known to cause OH: multiple system atrophy (MSA), Parkinson's disease, autoimmune autonomic ganglionopathy or progressive autonomic neuropathy (e.g., diabetic, amyloid).
• Orthostatic hypotension defined as a drop of systolic BP>30 mmHg or diastolic BP>15 mmHg.
• Adrenergic failure of at least moderate severity defined as CASS-adrenergic ≥3.
• Ambulatory and able to stand more than 3 minutes without pre-syncope.
• BMI <29.
• Ability to comply with study procedures and appointments.
• Normal cognition (able to understand the study, learn the maneuvers, and follow complex commands).
• Concomitant therapy with anticholinergic, alpha and beta agonists will be withdrawn 48 hours prior to autonomic evaluations. Midodrine will be withdrawn the night before evaluation. Fludrocortisone doses up to 0.2 mg per day will be permitted.
• The diagnosis of probable MSA requires 1) the presence of orthostatic hypotension or urinary incontinence, and 2) poorly levodopa responsive parkinsonism or cerebellar ataxia.
• The diagnosis of clinically definite Parkinson's disease requires 1) the presence of resting tremor, bradykinesia and rigidity, 2) clinical asymmetry, and 3) response to levodopa.
• The diagnosis of autoimmune autonomic ganglionopathy requires 1) a sub-cute onset, 2) the presence of generalized and severe autonomic failure (CASS>6), 3) selective involvement of autonomic nerve fibers and 4) positive alpha-3 nicotinic acetylcholine receptor auto-antibodies.

You may not qualify if…

• Pregnant or lactating females.
• Non-neurogenic OH, such as that due to medication or hypovolemia.
• Chronic illnesses or other central nervous system conditions that affect autonomic function.
• Established dementia.
• Debilitating ataxia.
• Moderate to severe lower extremity weakness.
• Severe systemic illness, such as end-stage pulmonary, cardiac or renal disease.

Where it is running

• Mayo Clinic in Rochester — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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