THE HEART STUDY
Health Evaluation in African Americans Using RAS Therapy
What is HEART?
HEART is an Alzheimer's prevention-based research clinical trial to see if an FDA-approved blood pressure medication has beneficial effects in African-Americans by affecting the blood flow and the amount of plaque in the brain. This type of blood pressure medication has been associated with reduced Alzheimer's risk in Caucasians, but this has not been evaluated in African-Americans.
If you are interested in participating, please call 404-712-7085 or 404-712-2654 to complete a phone screening.
HEART in the news:
Who is being studied?
To be eligible for this study, you must meet the following criteria:
A family history of Alzheimer's or other dementia
30 years or older
Have a healthy blood pressure or controlled high blood pressure
Have normal memory and thinking abilities
You may NOT be eligible if you meet these criteria:
Currently in another investigational drug study
Currently using a RAS medication (medications ending in -pril or -sartan)
Take a blood thinner
Are pregnant or nursing
What is involved?
If you participate in this research you will be taking a study medication for 8 months. The medication we are studying is Telmisartan, an FDA approved blood pressure medication - you will be randomly assigned to either this medication or a placebo and neither you nor the study coordinators will know which you have been assigned to, unless it is needed for your safety. You will also attend 4 to 5 clinic visits over the course of the 8 month trial. Two of these visits will be 5 to 6 hours long, the rest will be between 30 minutes to an hour. Some procedures will require that you fast for 8 or more hours prior. Procedures that will occur at these visits include:
An MRI scan of your brain
Medical and health related questionnaires
Lumbar puncture (if you have questions about this procedure, please go here)
Pulse Wave Velocity (aka Vascular Ultrasound)
Ambulatory blood pressure monitoring
This study is being conducted at three different Emory University locations:
Nell Hodgson Woodruff School of Nursing
1520 Clifton Road
Atlanta, GA 30322
Wesley Woods Health Center, 2nd floor - MRI
1821 Clifton Rd
Atlanta, GA 30307
Emory Alzheimer's Clinical Research Unit (ACRU)
6 Executive Park Dr, 2nd floor
Atlanta, GA 30329
Emory Brain Health Center
12 Executive Park Dr, 5th floor, Green Side
Atlanta, GA 30329
This grant was originally funded by the Alzheimer's Association and the National Institute of Health (NIH) in 2015.
Why is this research important?
While evidence linking the RAS and AD continues to mount, there are no therapeutic strategies targeting the RAS to prevent or delay AD. This Phase Ib RCT is the first step in understanding the potential of RAS acting medications in regard to CNS penetration and AD biomarkers with the future goal of repurposing an existing, inexpensive, safe drug. African Americans are not generally prescribed RAS medications, but when they are, doses higher than those prescribed to Caucasians are required to achieve BP control. It is unknown how these high doses alter systemic RAS levels or what dose is adequate to penetrate the CNS and alter brain RAS levels in African Americans. The dose is likely to be LOWER than the dose needed to alter BP, which is the case in Caucasians. Targeting individuals at high risk will help prevent and slow AD progression in as many people as possible, as fast as possible. Toward this goal, we must first understand the mechanistic potential of these medications in regard to the dose required to achieve CNS permeability, while safely controlling BP levels.
While African Americans represent only 13% of the U.S. population; they comprise 1/3 of the cost incurred from AD, half of which is concentrated in the South. African Americans comprise 61.4% of the population of Atlanta and 28.7% of the Georgia population. Thus, this trial has a unique opportunity to examine the influence of RAS medications in this high risk group. Emory is located in the “Stroke Belt” which has a high incidence of morbidity and mortality from cerebrovascular disease. In addition to having a two-fold risk for AD, African Americans are at increased risk for a host of vascular disorders. By characterizing the brain RAS, and its response to RAS medications in African Americans, we stand to glean invaluable information that could be used for prevention and treatment of vascular disease as well as AD and vascular dementia.