N/A
Completed N=40
Effects of Eplerenone on Cardiovascular Disease in HIV (MIRACLE HIV Study)
Source: ClinicalTrials.gov NCT02740179 ↗Enrolled (actual)
40
Serious AEs
2.5%
Results posted
Jun 2023
Primary outcomePrimary: Myocardial Perfusion by PET — 0.01; -0.07 unitless — p=0.72
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Myocardial Perfusion by PET |
0.01; -0.07 | 0.72 |
| PRIMARY Myocardial Perfusion by MRI |
0.09; -0.53 | 0.03 sig |
| PRIMARY Myocardial Inflammation |
0.9; -0.7 | 0.38 |
| SECONDARY Coronary Plaque |
0; 5 | 0.09 |
| SECONDARY Markers of Vascular Dysfunction |
0.00; 0.00 | 0.03 sig |
| SECONDARY Markers of Systemic Inflammation hsIL-6 |
-0.8; 0.2 | 0.09 |
| SECONDARY Markers of Systemic Inflammation hsCRP |
189; 591 | 0.36 |
| SECONDARY Markers of Immune Activation MCP-1 |
285; 292 | 0.88 |
| SECONDARY Markers of Immune Activation sCD163 |
-275; -160 | 0.17 |
| SECONDARY Markers of Subclinical Injury |
19.4; 2.8 | 0.28 |
| SECONDARY Markers of Fibrosis |
25; 1 | 0.32 |
| SECONDARY Arterial Inflammation |
-12.4; 5.1 | 0.003 sig |
| SECONDARY Markers of Arterial Inflammation |
3.0; 2.6 | 0.73 |
| SECONDARY Assessment of Cardiac Structure by Left Ventricular Mass on Cardiac Imaging |
1; 9 | 0.56 |
| SECONDARY Assessment of Cardiac Systolic Function Via Cardiac Imaging |
-1.3; 2.3 | 0.03 sig |
| SECONDARY Assessment of Cardiac Diastolic Function Via Cardiac Imaging |
-13; 10 | 0.03 sig |
Eligibility Criteria
Inclusion Criteria
- Ages 40-65 years
- Antiretroviral use (ART) >12 months and HIV viral load 110cm2
Exclusion Criteria
- 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.
- Unstable statin use 12 months) is allowed.
- Use of full dose ritonavir, nelfinavir, clarithromycin, and other strong inhibitors of CYP3A4, as well as CYP3A4 inducers.
- Continuous oral steroid use (equivalent to prednisone > 5 mg daily) within the last 3 months.
- Uncontrolled diabetes requiring insulin and/or HbA1c > 7.5%.
- Creatinine (Cr) > 1.5 mg/dL or estimated GFR 5.5 mEq/L.
- Hemoglobin 3x ULN.
- History of congestive heart failure, stroke, myocardial infarction, or known coronary artery disease.
- Pregnant, actively seeking pregnancy or breastfeeding.
- Estrogen, progestin derivative, or other sex steroid use within last 3 months. Stable physiologic testosterone replacement (> 3 months) is acceptable.
- Current bacterial or other infections.
- Active substance abuse.
- 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.
- Previous reaction or contraindication to iodine-containing contrast media and gadolinium.
- Coronary artery luminal narrowing >70% on coronary CTA.
Data sourced from ClinicalTrials.gov (NCT02740179). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.