Effects of Eplerenone on Cardiovascular Disease in HIV (MIRACLE HIV Study)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2022-03-17

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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HIV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Eplerenone

Eplerenone 50 mg twice daily along with lifestyle modification (counseling regarding diet and healthy activity) for 12 months

Group Type EXPERIMENTAL

Eplerenone

Intervention Type DRUG

Eplerenone 50mg by mouth twice daily

Lifestyle Modification

Intervention Type BEHAVIORAL

Counseling regarding diet and healthy activity

Placebo

Placebo twice daily along with lifestyle modification (counseling regarding diet and healthy activity) for 12 months

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo by mouth twice daily

Lifestyle Modification

Intervention Type BEHAVIORAL

Counseling regarding diet and healthy activity

Interventions

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Eplerenone

Eplerenone 50mg by mouth twice daily

Intervention Type DRUG

Placebo

Placebo by mouth twice daily

Intervention Type DRUG

Lifestyle Modification

Counseling regarding diet and healthy activity

Intervention Type BEHAVIORAL

Eligibility Criteria

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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 inhibitors 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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No