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| ID | Type | Description | Link |
|---|---|---|---|
| VA Project #5481-08-017 | Other Identifier | JJP VAMC RR&D |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Midodrine | Experimental | A drug to treat low blood pressure. |
|
| L-Name | Experimental | L-Name: A non-selective inhibitor of nitric oxide synthase and placebo. It has been used experimentally to induce hypertension. |
|
| Placebo | Placebo Comparator | Placebo: A pill with an inactive substance that looks like the study drug. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L-NAME | Drug | A non-selective inhibitor of nitric oxide synthase and placebo. It has been used experimentally to induce hypertension. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure | Blood pressure during the 4 hour period after no drug, L-NAME (IV: 1.0 mg/kg) and midodrine (PO: 10.0 mg) administration |
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Inclusion Criteria:
Spinal Cord Injured Subjects:
Control Subjects:
Exclusion Criteria:
Spinal Cord Injured Subjects:
Control Subjects:
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| Name | Affiliation | Role |
|---|---|---|
| Jill Wecht, EdD | VA Medical Center, Bronx | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Medical Center, Bronx | The Bronx | New York | 10468 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21762873 | Result | Wecht JM, Radulovic M, Rosado-Rivera D, Zhang RL, LaFountaine MF, Bauman WA. Orthostatic effects of midodrine versus L-NAME on cerebral blood flow and the renin-angiotensin-aldosterone system in tetraplegia. Arch Phys Med Rehabil. 2011 Nov;92(11):1789-95. doi: 10.1016/j.apmr.2011.03.022. Epub 2011 Jul 16. |
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Eligibility criteria were covered by the study coordinator prior to enrollment.
34 subjects were consented 24 completed testing. Subjects were recruited through the Center of Excellence for the Medical Consequences of Spinal Cord Injury (SCI) from June 2010 to August of 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | All Participants visited the laboratory on 3 occasions for a 4-5 hour observation of blood pressure following administration of a non-selective inhibitor of nitric oxide synthase (L-NAME) an alpha-agonist (midodrine) or placebo. The interventions were administered in random order on separate laboratory visits. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
30 subjects were anticipated but 34 were enrolled following an IRB approval to expand the n. Increased recruitment was due to a number of subjects withdrawing from participation for various reasons listed below.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | All participants were studied on three laboratory visits and underwent seated blood pressure assessment before and after administration of Midodrine, L-NAME or placebo, which were given in random order. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Blood Pressure | Posted | Mean | Standard Deviation | mmHg | Blood pressure during the 4 hour period after no drug, L-NAME (IV: 1.0 mg/kg) and midodrine (PO: 10.0 mg) administration |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1A | Spinal Cord Injured participants - Seated blood pressure after administration of a nitric oxide synthase inhibitor (L-NAME)over the course of 3 hours |
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Study population was relatively small and were not blinded to the interventions.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jill M. Wecht | James J Peters VAMC | 718 584-9000 | 3122 | jm.wecht@va.gov |
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| ID | Term |
|---|---|
| D007024 | Hypotension, Orthostatic |
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D054971 | Orthostatic Intolerance |
| D054969 | Primary Dysautonomias |
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D019331 | NG-Nitroarginine Methyl Ester |
| D008879 | Midodrine |
| ID | Term |
|---|---|
| D001120 | Arginine |
| D024361 | Amino Acids, Basic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Midodrine | Drug | To treat low blood pressure. |
|
| Placebo | Drug | A pill with an inactive substance that looks like the study drug. |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Spinal cord injured participants seated systolic Blood Pressure for 3 hours after administration of midodrine or
| OG003 | Arm 2B | Non disabled participants seated systolic blood pressure for 3 hours after administration of midodrine. |
| OG004 | Arm 3A | Spinal cord injured participants systolic blood pressure for 3 hours after administration of no drug |
| OG005 | Arm 3B | Non disabled participants seated systolic blood pressure for 3 hours after administration of no drug. |
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Arm 1B | Non disabled participants seated systolic blood pressure for 3 hours after administration of a nitric oxide synthase inhibitor (L-NAME) | 0 | 9 | 0 | 9 |
| EG002 | Arm 2A | Spinal cord injured participants seated systolic Blood Pressure for 3 hours after administration of midodrine or | 0 | 15 | 0 | 15 |
| EG003 | Arm 2B | Non disabled participants seated systolic blood pressure for 3 hours after administration of midodrine. | 0 | 9 | 0 | 9 |
| EG004 | Arm 3A | Spinal cord injured participants systolic blood pressure for 3 hours after administration of no drug | 0 | 15 | 0 | 15 |
| EG005 | Arm 3B | Non disabled participants seated systolic blood pressure for 3 hours after administration of no drug. | 0 | 9 | 0 | 9 |
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| D007022 | Hypotension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D000599 |
| Amino Acids, Diamino |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |