- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00835224
Safety and Efficacy of L-NAME and Midodrine to Increase MAP
March 21, 2014 updated by: US Department of Veterans Affairs
Safety and Efficacy of L-NAME and Midodrine to Increase MAP in Persons With Tetraplegia
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
34
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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Bronx, New York, United States, 10468
- VA Medical Center, Bronx
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Spinal Cord Injured Subjects:
- chronic spinal cord injury (1 year post injury) with a seated MAP of 65mmHg (almost all individuals with tetraplegia demonstrate this)
- Male or female with an age of 18 - 65 years
Control Subjects:
- Male or female with an age of 18 - 65 years
Exclusion Criteria:
Spinal Cord Injured Subjects:
- acute illness
- cardiovascular disease
- renal disease
- medications that affect the cardiovascular system
Control Subjects:
- acute illness
- cardiovascular disease
- renal disease
- medications that affect the cardiovascular system
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Midodrine
A drug to treat low blood pressure.
|
To treat low blood pressure.
|
Experimental: L-Name
L-Name: A non-selective inhibitor of nitric oxide synthase and placebo.
It has been used experimentally to induce hypertension.
|
A non-selective inhibitor of nitric oxide synthase and placebo.
It has been used experimentally to induce hypertension.
|
Placebo Comparator: Placebo
Placebo: A pill with an inactive substance that looks like the study drug.
|
A pill with an inactive substance that looks like the study drug.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Blood Pressure
Time Frame: Blood pressure during the 4 hour period after no drug, L-NAME (IV: 1.0 mg/kg) and midodrine (PO: 10.0 mg) administration
|
Blood pressure during the 4 hour period after no drug, L-NAME (IV: 1.0 mg/kg) and midodrine (PO: 10.0 mg) administration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jill Wecht, EdD, VA Medical Center, Bronx
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2010
Primary Completion (Actual)
June 1, 2013
Study Completion (Actual)
August 1, 2013
Study Registration Dates
First Submitted
January 30, 2009
First Submitted That Met QC Criteria
January 30, 2009
First Posted (Estimate)
February 3, 2009
Study Record Updates
Last Update Posted (Estimate)
April 23, 2014
Last Update Submitted That Met QC Criteria
March 21, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Wounds and Injuries
- Trauma, Nervous System
- Spinal Cord Diseases
- Autonomic Nervous System Diseases
- Primary Dysautonomias
- Orthostatic Intolerance
- Hypotension
- Spinal Cord Injuries
- Hypotension, Orthostatic
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Sympathomimetics
- Vasoconstrictor Agents
- Adrenergic alpha-1 Receptor Agonists
- Midodrine
Other Study ID Numbers
- A6161-W
- VA Project #5481-08-017 (Other Identifier: JJP VAMC RR&D)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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