- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02431936
Effectiveness of Prazosin on the Urinary Sodium Excretion Response to Mental Stress
June 19, 2019 updated by: Gregory Harshfield, Augusta University
Effectiveness of Prazosin on the Urinary Sodium Excretion Response to Mental Stress in a Randomized Double Blind Placebo Controlled Design
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Participants will test twice during this study, one of the weeks they will take Prazosin daily and the other week of testing they will take a placebo (sugar pill) daily in order to see if Prazosin changes how their body handles salt during stress.
The participants will not be informed as to which of the testing weeks is the Prazosin week or the placebo week.
This study will involve a screening visit, two first dose visits and two testing weeks over an approximate 5 week period (this include a one week "washout" period).
Each testing week will have a 3 day salt-controlled diet prior to testing and an approximate 3-hour testing period on Day 4. The 3-hour testing period will include 10 minutes of a baseline rest, 45 minutes of mild stress (competitive video game), and 45 minutes of a recovery rest.
A total of 4 blood and 4 urine samples will be collected during the 3-hour period.
Each blood draw will consist of about 4 teaspoons for a total of 16 teaspoons.
If the participants are female, a pregnancy test will be performed at the beginning of each testing visit (screening, first dose-1, test day-1, first dose-2 and test day-2) to confirm that they are not pregnant.
Muscle sympathetic nerve activity will be measured during testing through the insertion of electrodes just below the knee on the outer part of the right leg.
Additionally, an IV infusion will be administered for the phenylephrine challenge to insure total blockade of the sympathetic nervous system.
Study Type
Interventional
Enrollment (Actual)
50
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
-
-
Georgia
-
Augusta, Georgia, United States, 30912
- Augusta University
-
-
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 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Prazosin
Prescription for 1mg oral Prazosin twice per day will be administered for 71/2 days.
|
Double blind placebo controlled cross over trial to determine effectiveness of alpha adrenergic blocker in reducing sodium retention during stress.
Other Names:
|
Placebo Comparator: Placebo
Prescription for placebo identical to Prazosin dosage will be administered for twice daily for 71/2 days.
|
Sugar pill made to look identical to Prazosin intervention.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Urinary sodium excretion rate
Time Frame: 2 hours
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hemodynamics: change in systolic blood pressure
Time Frame: 2 hours
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Gregory A Harshfield, PhD, Augusta University
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
April 1, 2015
Primary Completion (Actual)
April 16, 2019
Study Completion (Actual)
April 16, 2019
Study Registration Dates
First Submitted
April 28, 2015
First Submitted That Met QC Criteria
April 30, 2015
First Posted (Estimate)
May 1, 2015
Study Record Updates
Last Update Posted (Actual)
June 20, 2019
Last Update Submitted That Met QC Criteria
June 19, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 611851
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
Dissemination will be carried out in a variety of ways that will be accessible to other scientists studying psychosocial stress, hypertension, and the control of fluid-electrolyte balance and blood pressure.
These include publications made available through PubMed-cited journals and presentations at scientific meetings and various organizations.
IPD Sharing Supporting Information Type
- Study Protocol
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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