Orthostatic Hypotension Clinical Trial
Official title:
The Efficacy of Adjustable Lower Abdominal Compression in Neurogenic Orthostatic Hypotension
Verified date | May 2014 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 13 |
Est. completion date | August 2012 |
Est. primary completion date | August 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
SUBJECTS We will study 15 patients of both genders with neurogenic orthostatic hypotension
(OH). Subjects will be recruited from the existing list of patients available in the
database of the Autonomic Disorders Center. Inclusion Criteria 1. Men and nonpregnant women aged 18-80 years. 2. 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). 3. Orthostatic hypotension defined as a drop of systolic BP>30 mmHg or diastolic BP>15 mmHg. 4. Adrenergic failure of at least moderate severity defined as CASS-adrenergic =3. 5. Ambulatory and able to stand more than 3 minutes without pre-syncope. 6. BMI <29. 7. Ability to comply with study procedures and appointments. 8. Normal cognition (able to understand the study, learn the maneuvers, and follow complex commands). 9. Concomitant therapy with anticholinergic, alpha and beta agonists will be withdrawn 48 hours prior to autonomic evaluations. Midodrine will be withdrawn the night before evaluation.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. Exclusion Criteria 1. Pregnant or lactating females. 2. Non-neurogenic OH, such as that due to medication or hypovolemia. 3. Chronic illnesses or other central nervous system conditions that affect autonomic function. 4. Established dementia. 5. Debilitating ataxia. 6. Moderate to severe lower extremity weakness. 7. Severe systemic illness, such as end-stage pulmonary, cardiac or renal disease. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic in Rochester | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference between averaged standing blood pressure with and without binders | A 1-minute averaged blood pressure is measured at 3 minutes of standing without abdominal binder and at 3, 4.5 and 6.5 minutes of standing with abdominal binders. All measurements are obtained during a single session. | 3-7 minutes | No |
Secondary | Difference in orthostatic symptom score with and without binders | Orthostatic symptoms are measured at 3 minutes of standing without abdominal binder, and at 3, 4.5 and 6.5 minutes of standing with abdominal binders. All measurements are obtained during a single session. | 3-7 minutes | No |
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