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Sponsored by: |
Department of Veterans Affairs |
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Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00237770 |
The aim of this investigation is to determine the blood pressure response to NOS inhibition, with L-NAME, in persons with tetraplegia compared to non-SCI control subjects and to establish if blood pressure can be increased while upright in those with tetraplegia. If blood pressure is increased with NOS inhibition in persons with tetraplegia, this would improve our treatment of the condition of low blood pressure during seated postures in individuals with tetraplegia.
Condition | Intervention | Phase |
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Hypotension Spinal Cord Injury |
Drug: N-Nitro L-arginine-methylester (L-NAME) Procedure: Head-up Tilt maneuver |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Crossover Assignment, Safety/Efficacy Study |
Official Title: | Prevention of Low Blood Pressure in Persons With Tetraplegia |
Estimated Enrollment: | 60 |
Study Start Date: | June 2003 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Placebo Comparator
Placebo control (normal saline) is employed on a separate visit during procedure.
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Drug: N-Nitro L-arginine-methylester (L-NAME)
A non-specific inhibitor of the nitric oxide synthase enzyme.
Procedure: Head-up Tilt maneuver
Participant will be placed onto tilt table and brought to 15 degrees of head up tilt for 60 minutes (intravenous infusion time). After this time, a progressive increase to 45 degrees will be completed with a 10 degree increase every 5 minutes. Participant will remain at 45 degrees for 45 minutes or until symptom onset.
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Despite disruption of central command of the vasculature during orthostatic maneuvers, individuals with tetraplegia are generally able to be seated in an upright position for long periods of time without developing symptoms of orthostatic intolerance. It must be appreciated however, that orthostatic hypotension may occur unpredictably in persons with chronic tetraplegia. This may result in a range of symptoms due to cerebral hypoperfusion from mild reduction in mental acuity to loss of consciousness. Nitric oxide (NO) is the most potent endogenous vasodilator which is synthesized by the enzyme NO synthase (NOS) and may be largely responsible for orthostatic hypotension in individuals with immobilizing conditions. Recent evidence suggests an up-regulation of inducible nitric oxide synthases (NOS) activity with prolonged exposure to hind limb suspension. The effects of NOS inhibition during orthostasis on blood pressure regulation in those with chronic tetraplegia may provide insight into effective pharmacological therapy to reduce or prevent pathologic orthostatic changes. Treatment with a NOS inhibitor may facilitate the process of mobilization in those with acute higher cord lesions.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: William Bauman, MD | william.bauman@va.gov |
United States, New York | |
VA Medical Center, Bronx | Recruiting |
Bronx, New York, United States, 10468 | |
Contact: Jill Wecht, EdD jm.wecht@va.gov | |
Contact: Michael F LaFountaine, EdD (718) 584-9000 ext 3121 Michael.lafountaine@va.gov | |
Principal Investigator: William Bauman, MD |
Principal Investigator: | William Bauman, MD | VA Medical Center, Bronx |
Responsible Party: | Department of Veterans Affairs ( Bauman, William - Principal Investigator ) |
Study ID Numbers: | B3600R |
Study First Received: | October 7, 2005 |
Last Updated: | August 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00237770 |
Health Authority: | United States: Federal Government; United States: Food and Drug Administration |
Blood Pressure Cardiovascular Autonomic Control Nitric Oxide NOS Inhibitor |
Orthostatic Hypotension Spinal Cord Injury Tetraplegia |
Hypotension Hypotension, Orthostatic Spinal Cord Diseases Vascular Diseases Wounds and Injuries Central Nervous System Diseases Disorders of Environmental Origin Quadriplegia |
Trauma, Nervous System Nitric Oxide Paralysis Spinal Cord Injuries Signs and Symptoms NG-Nitroarginine Methyl Ester Postural hypotension Neurologic Manifestations |
Nervous System Diseases Cardiovascular Diseases |