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Abdominal Compression in Orthostatic Hypotension

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01223391
First received: September 28, 2010
Last updated: April 22, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention
Autonomic Failure
Orthostatic Hypotension
 Device: Abdominal binder
Device: No abdominal binder

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Efficacy of Adjustable Lower Abdominal Compression in Neurogenic Orthostatic Hypotension

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Difference between averaged standing blood pressure with and without binders [ Time Frame: 3-7 minutes ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3-7 minutes ] [ Designated as safety issue: No ]
    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.


Enrollment: 13
Study Start Date: October 2010
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Abdominal binder
Standing with abdominal compression using elastic vs. non-elastic abdominal binders.
 Device: Abdominal binder
External abdominal compression sequentially applied at 20 mmHg for 3 minutes, maximal tolerable level for 1.5 minutes and comfortable level for 2 minutes.
Other Names:
  • Elastic abdominal binder
  • Non-elastic abdominal binder
Placebo Comparator: No abdominal binder
Standing without abdominal compression
 Device: No abdominal binder
Standing without abdominal binder for 3 minutes
Other Name: No abdominal binder

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 OH and its associated symptoms at comparable pressures and which binder is more effective in recovering standing BP and improving orthostatic symptoms.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

SUBJECTS We will study 15 patients of both genders with neurogenic 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 CNS 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01223391

Locations
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Jeffrey Basford, MD, PhD Mayo Clinic
  More Information

No publications provided

Responsible Party: Jeffrey Basford, MD, PhD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01223391     History of Changes
Other Study ID Numbers: 10-005203
Study First Received: September 28, 2010
Last Updated: April 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
orthostatic
abdominal compression

Additional relevant MeSH terms:
Hypotension
Hypotension, Orthostatic
Pure Autonomic Failure
Vascular Diseases
Cardiovascular Diseases
 Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 16, 2013