Abdominal Compression in Orthostatic Hypotension

NCT01223391 | Completed

• 1 other identifier: 10-005203
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Autonomic Failure; Orthostatic Hypotension

Keywords

orthostatic; abdominal compression

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Difference in orthostatic symptom score with and without binders

  3-7 minutes

Study Arms (2)

Abdominal binder

EXPERIMENTAL

Standing with abdominal compression using elastic vs. non-elastic abdominal binders.

Other: Abdominal binder

No abdominal binder

PLACEBO COMPARATOR

Standing without abdominal compression

Other: No abdominal binder

Interventions

Abdominal binder OTHER

External abdominal compression sequentially applied at 20 mmHg for 3 minutes, maximal tolerable level for 1.5 minutes and comfortable level for 2 minutes.

Also known as: Elastic abdominal binder, Non-elastic abdominal binder

Abdominal binder

No abdominal binder OTHER

Standing without abdominal binder for 3 minutes

No abdominal binder

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Pure Autonomic Failure; Hypotension, Orthostatic

Condition Hierarchy (Ancestors)

Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Orthostatic Intolerance; Hypotension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jeffrey Basford, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 28, 2010
• First Posted: October 19, 2010
• Study Start: October 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: May 12, 2014

Record last verified: 2014-05

Locations

US (1)