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

NCT02431936 | Completed Phase 2 DMC

• 1 other identifier: 611851
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Stress, Psychological; Blood Pressure

Keywords

Stress; Blood Pressure; Salt Sensitivity; Renin-Angiotensin-Aldosterone System; Sympathetic Nervous System

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Hemodynamics: change in systolic blood pressure

  2 hours

Study Arms (2)

Prazosin

EXPERIMENTAL

Prescription for 1mg oral Prazosin twice per day will be administered for 71/2 days.

Drug: Prazosin

Placebo

PLACEBO COMPARATOR

Prescription for placebo identical to Prazosin dosage will be administered for twice daily for 71/2 days.

Drug: Placebo

Interventions

Prazosin DRUG

Double blind placebo controlled cross over trial to determine effectiveness of alpha adrenergic blocker in reducing sodium retention during stress.

Also known as: minipress

Prazosin

Placebo DRUG

Sugar pill made to look identical to Prazosin intervention.

Also known as: sugar pill

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• of good general health
• not on any prescription medications
• between the ages of 18 and 50 years
• not pregnant
• African-American male or female

You may not qualify if:

• 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

Sponsors & Collaborators

• Augusta University: lead
• The University of Texas at Arlington: collaborator

Study Sites (1)

Augusta University

Augusta, Georgia, 30912, United States

Location

MeSH Terms

Conditions

Hypertension; Stress, Psychological

Interventions

Prazosin; Sugars

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Carbohydrates

Study Officials

• Gregory A Harshfield, PhD

  Augusta University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: April 28, 2015
• First Posted: May 1, 2015
• Study Start: April 1, 2015
• Primary Completion: April 16, 2019
• Study Completion: April 16, 2019
• Last Updated: June 20, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

US (1)