Effectiveness of Avapro in Obese Normotensive/Hypertensive African Americans
Information source: Georgia Regents University
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension; Obesity
Intervention: Irbesartan (Drug); Placebo (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Georgia Regents University Official(s) and/or principal investigator(s): Gregory A Harshfield, PhD, Principal Investigator, Affiliation: Georgia Regents University
Overall contact: Kimberly Norland, Phone: 706-721-1755, Email: knorland@gru.edu
Summary
The purpose of this study is to test the hypothesis that hypertension increases the
anti-natriuretic effects of an angiotensin receptor antagonist during mental stress in
overweight/obese AA's who retain sodium during mental stress.
Clinical Details
Official title: Effectiveness of Avapro in the Treatment of Salt Sensitivity in Both Normotensive and Untreated Hypertensive Obese African Americans: A Randomized Double Blind Placebo Controlled Trial
Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Urinary sodium excretion rate
Secondary outcome: Hemodynamics
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 we showed that a
significant number of AAs hold onto or retain salt during mental stress (a. k.a. - sodium
retainers). We also showed sodium retention increased with increasing body size. Finally,
we showed the response was corrected with Avapro (irbesartan), an angiotensin II blocker.
This drug has been approved by the FDA (Food and Drug Administration) to treat hypertension
(high blood pressure). It blocks the action of angiotensin II (a chemical secreted by the
kidney), permitting the blood vessels to relax and dilate (widen) and also stops the kidneys
from holding onto salt. This in turn, should lower the blood pressure. We believe that the
increased salt load and resulting blood pressure load contributes to the eventual
development of hypertension, a question we will address in this study by comparing the
responses of normotensive (normal blood pressure) and hypertensive (high blood pressure)
patients, matched for body size. Furthermore, we will determine if subjects show greater
responses than normal, suggesting sodium retention is associated with the progression to
hypertension. Half of the subjects who participate in this study will have been diagnosed
by a physician at the GRU Hypertension Clinic with hypertension and currently not on
anti-hypertensive medication. The other half will be normotensive. Participants will test
twice during this study, one of the weeks they will take Avapro daily and the other week of
testing they will take a placebo (sugar pill) daily in order to see if Avapro changes how
their body handles salt during stress. They will not be informed as to which of the testing
weeks is the Avapro 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 they 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- African-American,
- not pregnant,
- have a BMI (Body Mass Index) rate of 25 kg/m2 or higher,
- currently not taking any medications that may affect my blood pressure,
- sodium retainer.
Exclusion Criteria:
- not African-American,
- pregnant,
- a BMI (Body Mass Index) rate less than 25 kg/m2,
- taking medications that will affect my blood pressure,
- sodium excretor.
Locations and Contacts
Kimberly Norland, Phone: 706-721-1755, Email: knorland@gru.edu
Georgia Regents University, Augusta, Georgia 30912, United States; Recruiting Kimberly Norland, Phone: 706-721-1755, Email: knorland@gru.edu Gregory A Harshfield, PhD, Principal Investigator Ryan A Harris, PhD, Sub-Investigator Yanbin Dong, MD, PhD, Sub-Investigator
Additional Information
Starting date: September 2014
Last updated: March 5, 2015
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