Abdominal Compression in Orthostatic Hypotension

Orthostatic Hypotension Clinical Trial

Official title:

The Efficacy of Adjustable Lower Abdominal Compression in Neurogenic Orthostatic Hypotension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01223391
• Other study ID #: 10-005203
• Status: Completed
• Phase: N/A
• First received: September 28, 2010
• Last updated: May 9, 2014
• Start date: October 2010
• Est. completion date: August 2012

Study information

• Verified date: May 2014
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autonomic Failure
• Hypotension
• Hypotension, Orthostatic
• Orthostatic Hypotension
• Pure Autonomic Failure

Intervention

Other:
• 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.
• No abdominal binder
Standing without abdominal binder for 3 minutes

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

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