Note: This study is currently only recruiting patients in the hospital.
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Investigating Heart Disease and Inflammation in HIV (The MIRACLE HIV Study)
This project is not recruiting.
Overview
What we are studying
This research study aims to assess the effectiveness of a drug called eplerenone and/or lifestyle modification among people infected with HIV who have metabolic complications such as increased abdominal fat and heart disease. We are evaluating the effects of lifestyle modification and eplerenone to see if they can decrease the risk of heart disease and improve blood flow, inflammation and plaque in the heart. The lifestyle modification program includes dietary counseling as well as tools to increase your physical activity. The drug eplerenone and lifestyle modification are two strategies that are likely to improve the health status of individuals with HIV associated metabolic abnormalities.
Why it is important
HIV-infected individuals treated with antiretroviral medications are living longer, but have an increased risk of heart disease when compared to non-HIV-infected individuals. A hormone called aldosterone, which regulates blood pressure and sodium balance, is elevated in the HIV population in association with increased belly fat and altered glucose metabolism. Elevations in aldosterone hormone may also be associated with abnormal blood flow, inflammation, and coronary plaque in the heart. This study is being conducted to evaluate whether therapies to reduce the actions of aldosterone may decrease the burden and progression of heart disease in the HIV population.
What we hope to accomplish
In this 12 month study, patients will be randomly selected (that is assigned by chance) to receive eplerenone or placebo for a 1 year study. Everyone in the study will participate in the lifestyle modification program. The program consists of dietary counseling throughout the duration of the study. The potential benefits from this study include improved cardiovascular (heart/blood vessel) health and overall body composition.
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Principal Investigator
Who can participate
HIV positive males and females, ages 40-65, who have been on a stable antiretroviral regimen for greater than 12 months. Subjects must have the ability and willingness to modify lifestyle behavior and make changes in their diet and exercise regimes. This research study entails a 1-year commitment.
What you may be asked to do
Office visit, Imaging of the heart, Blood draw
Project activities may include:
- Blood draw
- Office visit
- MRI scan
- PET scan
- Overnight stay
- Medication
Estimated Time Commitment
1 year
What You May Get
Physical exam and evaluation of cardiovascular risk, nutrition and exercise counseling for 1 year, reimbursement for transportation, and up to $670-$820
Location
MGH Clinical Research Center (CRC), Massachusetts General Hospital
55 Fruit Street, White 12, Boston MA 02114
Center for Clinical Investigation (CCI), Brigham and Women’s Hospital
75 Francis Street, Tower 9A, Boston MA 02115
Travel
- Accessible by public transportation
- Parking available
- Parking reimbursed
- Local travel reimbursed
Travel and Parking Details
Additional Information
Study Phase
Phase 2/3: This project studies whether a medication or treatment works for people with a specific disease or condition. It may specifically look at different groups of people, different dosages, or different combinations of medications or treatments. The drug or treatment has been studied for safety in healthy volunteers, but the project will continue to look at safety and short term side effects.
Funding Source
- NIH or Other Federal