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| Name | Class |
|---|---|
| Kessler Foundation | OTHER |
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The purpose of this study is to identify the effects of non-pharmacological and pharmacological anti-hypotensive treatment interventions on orthostatic hemodynamic responses, symptoms of autonomic dysreflexia and orthostatic hypotension, and levels of fatigue and comfort in hypotensive individuals with SCI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study 1 | Experimental | Twenty-five participants will be asked to visit the laboratory on 6 occasions, for an open-label, dose escalation trial to determine the effect of midodrine and droxidopa on supine and seated blood pressure and on symptoms of autonomic dysreflexia and orthostatic hypotension. |
|
| Study 2 | Experimental | Determine the effects of compression garments, midodrine, and droxidopa, compared to placebo, on orthostatic hemodynamics, symptoms of AD and OH and reporting of fatigue and thermal comfort. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midodrine Hydrochloride | Drug | Determine best drug and dose to increase and stabilize SBP during orthostatic tilt |
|
| Measure | Description | Time Frame |
|---|---|---|
| Systolic blood pressure | determine differences in systolic blood pressure after midodrine, droxidopa, compression stockings and placebo | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Cerebral blood flow velocity | determine differences in cerebral blood flow velocity after midodrine, droxidopa, compression stockings and placebo | 3 years |
| Symptoms of autonomic dysreflexia and orthostatic hypotension |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matt G. Maher, MS | Contact | 9733243588 | matt.maher@va.gov |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kessler Foundation | Recruiting | West Orange | New Jersey | 07052 | United States |
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| ID | Term |
|---|---|
| D007022 | Hypotension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D008879 | Midodrine |
| D015103 | Droxidopa |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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determine differences in symptoms after midodrine, droxidopa, compression stockings and placebo
| 3 years |
| James J Peters VA Medical Center | Recruiting | The Bronx | New York | 10468 | United States |
|
| D000588 |
| Amines |
| D009638 | Norepinephrine |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D012694 | Serine |
| D021542 | Amino Acids, Neutral |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |