Hypertension Clinical Trial
Official title:
Effectiveness of Prazosin on the Urinary Sodium Excretion Response to Mental Stress in a Randomized Double Blind Placebo Controlled Design
NCT number | NCT02431936 |
Other study ID # | 611851 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | April 2015 |
Est. completion date | April 16, 2019 |
Verified date | June 2019 |
Source | Augusta University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
High blood pressure, or hypertension, is a serious problem in the African-American (AA) population which affects nearly 7 of every 10 AAs in our area. Previously the investigators showed that a significant number of AAs held onto or retained salt during mental stress (sodium retainers). The investigators believe that the increased salt load and resulting blood pressure load contributes to the eventual development of hypertension in these individuals. The purpose of this study is to find out if this response is due to the direct stimulation of the kidney (the organ that controls salt levels in the body, by the brain). To do this, the investigators will determine if a drug that stops the connection between the brain and the kidney during mental stress will prevent sodium retention in sodium retainers. Prazosin is an alpha adrenergic receptor blocker that has been approved by the Food and Drug Administration (FDA). None of the subjects who participate in this study have high blood pressure. The subjects will not know which testing week is the drug week and which is the placebo week.
Status | Completed |
Enrollment | 50 |
Est. completion date | April 16, 2019 |
Est. primary completion date | April 16, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: - of good general health - not on any prescription medications - between the ages of 18 and 50 years - not pregnant - African-American male or female Exclusion Criteria: - not African-American - pregnant - taking medications that will affect blood pressure - not in good general health - younger than 18 years of age or older than 50 years of age |
Country | Name | City | State |
---|---|---|---|
United States | Augusta University | Augusta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Augusta University | The University of Texas at Arlington |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Urinary sodium excretion rate | Primary variable of interest is the difference in stress induced changes in sodium excretion between placebo and treatment conditions in African-Americans who retain sodium during stress. | 2 hours | |
Secondary | Hemodynamics: change in systolic blood pressure | Measures of change in systolic blood pressure compared to changes in sodium excretion in treatment versus placebo in African-Americans who retain sodium during stress. | 2 hours |
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