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Sponsored by: |
Department of Veterans Affairs |
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Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00835224 |
After a spinal cord injury the brain is no longer completely in control of the body below the level of injury. This affects many organs and systems in the body, we are interested in understanding how a spinal cord injury affects blood pressure and blood flow to the brain. We are going to study blood pressure while the person is seated in a wheelchair before and after we give the subject medications which should increase blood pressure in a laboratory setting and over the course of a normal day in persons with spinal cord injury.
Condition | Intervention | Phase |
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Orthostatic Hypotension Spinal Cord Injury |
Drug: L-NAME Drug: Midodrine Hydrochloride |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Single Group Assignment, Safety/Efficacy Study |
Official Title: | Safety and Efficacy of L-NAME and Midodrine to Increase MAP in Persons With Tetraplegia |
Estimated Enrollment: | 105 |
Study Start Date: | May 2009 |
Estimated Study Completion Date: | March 2012 |
Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Blood pressure profile before and after administration of either Midodrine, L-NAME or placebo while the person is seated in a wheelchair and over the course of a normal day
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Drug: L-NAME
Nitric Oxide inhibitor
Drug: Midodrine Hydrochloride
Alpha agonist and placebo
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Blood pressure regulation is compromised in persons with tetraplegia due to de-centralization of sympathetic cardiovascular control, associated with hypotension during upright positioning (7, 10, 18, 33). An alpha receptor agonist (midodrine hydrochloride) has been reported to raise blood pressure in persons with tetraplegia (25, 26, 30). Midodrine is the only drug that is presently available to treat orthostatic hypotension. In the clinical armamentarium, it is always beneficial to have agents from multiple drug classes to treat a condition. In the treatment of hypertension, several classes of drugs may be prescribed to lower blood pressure, alone or in combination. The clinician and patient would benefit if another class of drug, with a totally separate mechanism of action, were available to treat orthostatic hypotension. A nitric oxide synthase inhibitor (NOSi), nitro-L-arginine methyl ester (L-NAME), has been shown by our group to "normalize" blood pressure in persons with tetraplegia (32). The safety and efficacy of these two hypertensive agents has not been investigated or compared in persons with chronic tetraplegia. Although the mechanism of action of each of these agents is appreciated, the relative cardiovascular effect in persons with SCI compared with controls is not known. The study will determine the efficacy and safety of these two medications at restoring mean arterial pressure (MAP) during daily activities in persons with chronic tetraplegia. Furthermore, the implication of restoring MAP to normal levels (80 10 mmHg) in individuals with tetraplegia on cardiovascular, autonomic, hormonal and cognitive function.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Tetraplegia Subjects:
Control Subjects:
1) Male or female with an age of 18 - 65 years
Exclusion Criteria:
Tetraplegia Subjects:
Control Subjects:
Contact: Dwindally Rosado Rivera, EdD | (718) 584-9000 ext 3128 | dwindally.rosadorivera@va.gov |
United States, New York | |
VA Medical Center, Bronx | |
Bronx, New York, United States, 10468 |
Principal Investigator: | Jill Wecht, EdD | VA Medical Center, Bronx |
Responsible Party: | Department of Veterans Affairs ( Wecht, Jill - Principal Investigator ) |
Study ID Numbers: | A6161W, VA Project #5481-08-017 |
Study First Received: | January 30, 2009 |
Last Updated: | January 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00835224 History of Changes |
Health Authority: | United States: Federal Government; United States: Food and Drug Administration |
Hypotension Neurotransmitter Agents Adrenergic alpha-Agonists Hypotension, Orthostatic Adrenergic Agents Spinal Cord Diseases Vascular Diseases Wounds and Injuries Central Nervous System Diseases Disorders of Environmental Origin Cardiovascular Agents |
Quadriplegia Trauma, Nervous System Adrenergic Agonists Nitric Oxide Spinal Cord Injuries NG-Nitroarginine Methyl Ester Vasoconstrictor Agents Midodrine Postural Hypotension Peripheral Nervous System Agents |
Hypotension Neurotransmitter Agents Hypotension, Orthostatic Spinal Cord Diseases Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Disorders of Environmental Origin Adrenergic Agonists Spinal Cord Injuries Therapeutic Uses Midodrine Vasoconstrictor Agents |
Cardiovascular Diseases Adrenergic alpha-Agonists Sympathomimetics Nervous System Diseases Wounds and Injuries Vascular Diseases Central Nervous System Diseases Trauma, Nervous System Cardiovascular Agents Pharmacologic Actions Autonomic Agents Peripheral Nervous System Agents |