Effects of Eplerenone on Cardiovascular Disease in HIV (MIRACLE HIV Study)
| Status: | Recruiting |
|---|---|
| Conditions: | Peripheral Vascular Disease, HIV / AIDS |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 40 - 65 |
| Updated: | 3/15/2019 |
| Start Date: | January 2017 |
| Contact: | Suman Srinivasa, MD, MS |
| Email: | ssrinivasa@mgh.harvard.edu |
| Phone: | 6177269109 |
Mineralocorticoid Receptor Antagonism for Cardiovascular Health in HIV--The MIRACLE HIV Study
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 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.
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 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.
This is a 12 month randomized, placebo controlled study enrolling HIV-infected individuals
with no known history of cardiovascular disease. Eplerenone is a mineralocorticoid receptor
antagonist, which can block aldosterone activation. This medication is approved by the FDA
for high blood pressure and heart failure. This study aims to investigate the effect of
eplerenone on other measures of cardiovascular disease in HIV. Using PET, MRI, and CT imaging
technology, this study will evaluate whether eplerenone can improve coronary flow reserve and
myocardial inflammation/fibrosis, in addition to atherosclerotic plaque build-up among the
HIV population. The study also includes teaching on lifestyle modification to promote a
healthy diet and exercise program.There are 3 overnight visits in addition to safety visits.
with no known history of cardiovascular disease. Eplerenone is a mineralocorticoid receptor
antagonist, which can block aldosterone activation. This medication is approved by the FDA
for high blood pressure and heart failure. This study aims to investigate the effect of
eplerenone on other measures of cardiovascular disease in HIV. Using PET, MRI, and CT imaging
technology, this study will evaluate whether eplerenone can improve coronary flow reserve and
myocardial inflammation/fibrosis, in addition to atherosclerotic plaque build-up among the
HIV population. The study also includes teaching on lifestyle modification to promote a
healthy diet and exercise program.There are 3 overnight visits in addition to safety visits.
Inclusion Criteria:
1. Ages 40-65 years
2. Antiretroviral use (ART) >12 months and HIV viral load <100 copies/mL
3. VAT> 110cm2
Exclusion Criteria:
1. Antihypertensive use including, ACE Inhibitor, ARB, MR blockade, diuretic, potassium
(K) supplementation; or BP>140/90 mmHg. Stable use (>3 months) of beta-blockers or
calcium channel blockers (CCB) (except verapamil) is allowed.
2. Unstable statin use <12 months. Stable use (>12 months) is allowed.
3. Use of full dose ritonavir, nelfinavir, clarithromycin, and other strong inhibitiors
of CYP3A4, as well as CYP3A4 inducers.
4. Continuous oral steroid use (equivalent to prednisone > 5 mg daily) within the last 3
months.
5. Uncontrolled diabetes requiring insulin and/or HbA1c > 7.5%.
6. Creatinine (Cr) > 1.5 mg/dL or estimated GFR<60 mL/min/1.73m2.
7. K > 5.5 mEq/L.
8. Hemoglobin < 10 g/dL.
9. Known liver disease or ALT >3x ULN.
10. History of congestive heart failure, stroke, myocardial infarction, or known coronary
artery disease.
11. Pregnant, actively seeking pregnancy or breastfeeding.
12. Estrogen, progestin derivative, or other sex steroid use within last 3 months. Stable
physiologic testosterone replacement (> 3 months) is acceptable.
13. Current bacterial or other infections.
14. Active substance abuse.
15. Significant radiation exposure over the course of the year prior to randomization
(e.g., radiation therapy, PCI, catheter ablation of arrhythmia) within 12 months of
randomization.
16. Previous reaction or contraindication to iodine-containing contrast media and
gadolinium.
17. Coronary artery luminal narrowing >70% on coronary CTA.
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
Boston, Massachusetts 02114
617-724-5200
Phone: 617-724-9109
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