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Effectiveness of Prazosin on the Urinary Sodium Excretion Response to Mental Stress

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ClinicalTrials.gov Identifier: NCT02431936
Recruitment Status : Completed
First Posted : May 1, 2015
Last Update Posted : June 20, 2019
Sponsor:
Collaborator:
The University of Texas at Arlington
Information provided by (Responsible Party):
Gregory Harshfield, Augusta University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hypertension Stress, Psychological Blood Pressure Drug: Prazosin Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effectiveness of Prazosin on the Urinary Sodium Excretion Response to Mental Stress in a Randomized Double Blind Placebo Controlled Design
Study Start Date : April 2015
Actual Primary Completion Date : April 16, 2019
Actual Study Completion Date : April 16, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stress

Arm Intervention/treatment
Experimental: Prazosin
Prescription for 1mg oral Prazosin twice per day will be administered for 71/2 days.
Drug: Prazosin
Double blind placebo controlled cross over trial to determine effectiveness of alpha adrenergic blocker in reducing sodium retention during stress.
Other Name: minipress

Placebo Comparator: Placebo
Prescription for placebo identical to Prazosin dosage will be administered for twice daily for 71/2 days.
Drug: Placebo
Sugar pill made to look identical to Prazosin intervention.
Other Name: sugar pill




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02431936


Locations
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United States, Georgia
Augusta University
Augusta, Georgia, United States, 30912
Sponsors and Collaborators
Augusta University
The University of Texas at Arlington
Investigators
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Study Director: Gregory A Harshfield, PhD Augusta University
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Responsible Party: Gregory Harshfield, Director, Augusta University
ClinicalTrials.gov Identifier: NCT02431936    
Other Study ID Numbers: 611851
First Posted: May 1, 2015    Key Record Dates
Last Update Posted: June 20, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Keywords provided by Gregory Harshfield, Augusta University:
Stress
Blood Pressure
Salt Sensitivity
Renin-Angiotensin-Aldosterone System
Sympathetic Nervous System
Additional relevant MeSH terms:
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Stress, Psychological
Behavioral Symptoms
Prazosin
Antihypertensive Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs