Back to resultsAbdominal Compression in Orthostatic Hypotension
Primary Purpose
Autonomic Failure, Orthostatic Hypotension
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Abdominal binder
No abdominal binder
Sponsored by
About this trial
This is an interventional treatment trial for Autonomic Failure focused on measuring orthostatic, abdominal compression
Eligibility Criteria
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
- 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- Concomitant therapy with anticholinergic, alpha and beta agonists will be withdrawn 48 hours prior to autonomic evaluations. Midodrine will be withdrawn the night before evaluation.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.
Exclusion Criteria
- 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.
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Abdominal binder
No abdominal binder
Arm Description
Standing with abdominal compression using elastic vs. non-elastic abdominal binders.
Standing without abdominal compression
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01223391
Brief Title
Abdominal Compression in Orthostatic Hypotension
Official Title
The Efficacy of Adjustable Lower Abdominal Compression in Neurogenic Orthostatic Hypotension
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
In 3 protocols, patients will undergo standing maneuvers, measured abdominal compressions, continuous BP monitoring and symptoms, ease-of-use and compliance scoring. In protocol 1, patients will exert abdominal compression to maximal tolerable and comfortable levels and values will be recorded. In protocol 2, patients will perform 3 standing maneuvers following a preceding rest period with and without abdominal compression at 20 mmHg (binders used in random order). In protocol 3, the standing maneuvers will be extended and the investigator will adjust binders to levels of abdominal compression corresponding to what patient gauged as maximal tolerable and comfortable levels. Comparison of outcome measures will establish which binder achieves higher abdominal compression, is easier to adjust, likely will be used in the future, if elastic and adjustable binders are equally effective in attenuating Orthostatic Hypotension and its associated symptoms at comparable pressures and which binder is more effective in recovering standing BP and improving orthostatic symptoms.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autonomic Failure, Orthostatic Hypotension
Keywords
orthostatic, abdominal compression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Abdominal binder
Arm Type
Experimental
Arm Description
Standing with abdominal compression using elastic vs. non-elastic abdominal binders.
Arm Title
No abdominal binder
Arm Type
Placebo Comparator
Arm Description
Standing without abdominal compression
Intervention Type
Other
Intervention Name(s)
Abdominal binder
Other Intervention Name(s)
Elastic abdominal binder, Non-elastic abdominal binder
Intervention Description
External abdominal compression sequentially applied at 20 mmHg for 3 minutes, maximal tolerable level for 1.5 minutes and comfortable level for 2 minutes.
Intervention Type
Other
Intervention Name(s)
No abdominal binder
Intervention Description
Standing without abdominal binder for 3 minutes
Primary Outcome Measure Information:
Title
Difference between averaged standing blood pressure with and without binders
Description
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.
Time Frame
3-7 minutes
Secondary Outcome Measure Information:
Title
Difference in orthostatic symptom score with and without binders
Description
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.
Time Frame
3-7 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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.
Exclusion Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Basford, MD, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
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