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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eplerenone | Experimental | Eplerenone 50 mg twice daily along with lifestyle modification (counseling regarding diet and healthy activity) for 12 months |
|
| Placebo | Placebo Comparator | Placebo twice daily along with lifestyle modification (counseling regarding diet and healthy activity) for 12 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eplerenone | Drug | Eplerenone 50mg by mouth twice daily |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Myocardial Perfusion by PET | Change (value at 12 months minus value at baseline) in myocardial perfusion assessed by coronary flow reserve measured via cardiac positron emission tomography. Coronary flow reserve is given by the ratio of blood flow at stress during maximal dilation of the coronary arteries to blood flow at rest. | 12 Months |
| Myocardial Perfusion by MRI | Change (value at 12 months minus value at baseline) in myocardial perfusion assessed by myocardial blood flow measured via cardiac magnetic resonance imaging | 12 Months |
| Myocardial Inflammation | Change (value at 12 months minus value at baseline) in myocardial inflammation measured by extracellular mass index (a measure of the inflammation within the heart) via cardiac magnetic resonance imaging | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Coronary Plaque | Change (value at 12 months minus value at baseline) in coronary plaque measured via coronary computed tomography angiogram assessed by coronary calcium score Scale: minimum 0 to maximum no limit, higher score indicates more plaque | 12 Months |
| Markers of Vascular Dysfunction |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26086328 | Background | Srinivasa S, Fitch KV, Wong K, Torriani M, Mayhew C, Stanley T, Lo J, Adler GK, Grinspoon SK. RAAS Activation Is Associated With Visceral Adiposity and Insulin Resistance Among HIV-infected Patients. J Clin Endocrinol Metab. 2015 Aug;100(8):2873-82. doi: 10.1210/jc.2015-1461. Epub 2015 Jun 18. | |
| 41994349 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | Eplerenone | Eplerenone 50 mg twice daily along with lifestyle modification (counseling regarding diet and healthy activity) for 12 months Eplerenone: Eplerenone 50mg by mouth twice daily Lifestyle Modification: Counseling regarding diet and healthy activity |
| FG001 | Placebo | Placebo twice daily along with lifestyle modification (counseling regarding diet and healthy activity) for 12 months Placebo: Placebo by mouth twice daily Lifestyle Modification: Counseling regarding diet and healthy activity |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Eplerenone | Eplerenone 50 mg twice daily along with lifestyle modification (counseling regarding diet and healthy activity) for 12 months Eplerenone: Eplerenone 50mg by mouth twice daily Lifestyle Modification: Counseling regarding diet and healthy activity |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Myocardial Perfusion by PET | Change (value at 12 months minus value at baseline) in myocardial perfusion assessed by coronary flow reserve measured via cardiac positron emission tomography. Coronary flow reserve is given by the ratio of blood flow at stress during maximal dilation of the coronary arteries to blood flow at rest. | Analyses performed on data available | Posted | Mean | Standard Deviation | unitless | 12 Months |
|
12 Months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Eplerenone | Eplerenone 50 mg twice daily along with lifestyle modification (counseling regarding diet and healthy activity) for 12 months Eplerenone: Eplerenone 50mg by mouth twice daily Lifestyle Modification: Counseling regarding diet and healthy activity |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Medical condition leading to death | Social circumstances | Non-systematic Assessment | Unrelated to study medication |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Cardiac disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Steven K. Grinspoon | Massachusetts General Hospital | 617-724-9109 | sgrinspoon@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 8, 2022 | Mar 9, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D009205 | Myocarditis |
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
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| ID | Term |
|---|---|
| D000077545 | Eplerenone |
| ID | Term |
|---|---|
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 |
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| Drug |
Placebo by mouth twice daily |
|
| Lifestyle Modification | Behavioral | Counseling regarding diet and healthy activity |
|
Change (value at 12 months minus value at baseline) in serum hs-cTnT |
| 12 Months |
| Markers of Systemic Inflammation hsIL-6 | Change (value at 12 months minus value at baseline) in plasma hsIL-6 | 12 Months |
| Markers of Systemic Inflammation hsCRP | Change (value at 12 months minus value at baseline) in plasma hsCRP | 12 Months |
| Markers of Immune Activation MCP-1 | Change (value at 12 months minus value at baseline) in plasma MCP-1 | 12 Months |
| Markers of Immune Activation sCD163 | Change (value at 12 months minus value at baseline) in plasma sCD163 | 12 Months |
| Markers of Subclinical Injury | Change (value at 12 months minus value at baseline) in serum NT-proBNP | 12 Months |
| Markers of Fibrosis | Change (value at 12 months minus value at baseline) in myocardial fibrosis measured by T1 (a signal intensity that measures fibrosis) via cardiac magnetic resonance imaging | 12 Months |
| Arterial Inflammation | Percentage change (value at 12 months minus value at baseline) in target to background ratio (a measure of arterial inflammation) of the index vessel measured via positron emission tomography/computed tomography | 12 Months |
| Markers of Arterial Inflammation | Change (value at 12 months minus value at baseline) in plasma LpPLA2 | 12 Months |
| Assessment of Cardiac Structure by Left Ventricular Mass on Cardiac Imaging | Change (value at 12 months minus value at baseline) in left ventricular mass on cardiac magnetic resonance imaging | 12 Months |
| Assessment of Cardiac Systolic Function Via Cardiac Imaging | Change (value at 12 months minus value at baseline) in global circumferential strain (GCS) on cardiac magnetic resonance imaging | 12 Months |
| Assessment of Cardiac Diastolic Function Via Cardiac Imaging | Change (value at 12 months minus value at baseline) in left ventricular end diastolic volume on cardiac magnetic resonance imaging | 12 Months |
| Murthy A, Kolossvary M, Walpert AR, Sanchez E, Abohashem S, Tawakol A, Adler GK, Grinspoon SK, Srinivasa S. Proteomic Profile After Intervention With Eplerenone Among Persons With HIV. Open Forum Infect Dis. 2026 Apr 8;13(4):ofag207. doi: 10.1093/ofid/ofag207. eCollection 2026 Apr. |
| 40478895 | Derived | Walpert AR, Gupta M, Dunderdale CN, Haptu HH, Manandhar M, deFilippi CR, Burdo TH, Lee H, Kwong RY, Srinivasa S. Exploring the PREVENT HF score and myocardial function among persons with HIV. AIDS. 2025 Sep 1;39(11):1592-1597. doi: 10.1097/QAD.0000000000004252. Epub 2025 Jun 4. |
| 38813261 | Derived | Srinivasa S, Walpert AR, Huck D, Thomas TS, Dunderdale CN, Lee H, Dicarli MF, Adler GK, Grinspoon SK. Coronary Microvascular Dysfunction Is Present Among Well-Treated Asymptomatic Persons With HIV and Similar to Those With Diabetes. Open Forum Infect Dis. 2024 Apr 26;11(5):ofae234. doi: 10.1093/ofid/ofae234. eCollection 2024 May. |
| 38090987 | Derived | Srinivasa S, Abohashem S, Walpert AR, Dunderdale CN, Iyengar S, Shen G, Jerosch-Herold M, deFilippi CR, Robbins GK, Lee H, Kwong RY, Adler GK, Tawakol A, Grinspoon SK. Mineralocorticoid Receptor Antagonism by Eplerenone and Arterial Inflammation in HIV: The MIRABELLA HIV Study. JAMA Cardiol. 2024 Feb 1;9(2):189-194. doi: 10.1001/jamacardio.2023.4578. |
| 37559752 | Derived | Thomas TS, Dunderdale C, Lu MT, Walpert AR, Shen G, Young MCH, Torriani M, Chu JT, Haptu HH, Manandhar M, Wurcel A, Adler GK, Grinspoon SK, Srinivasa S. Visceral Adiposity Index as a Measure of Cardiovascular Disease in Persons With Human Immunodeficiency Virus. Open Forum Infect Dis. 2023 Jul 24;10(8):ofad398. doi: 10.1093/ofid/ofad398. eCollection 2023 Aug. |
| 37243345 | Derived | Srinivasa S, Walpert AR, Thomas TS, Huck DM, Jerosch-Herold M, Islam S, Lu MT, Burdo TH, deFilippi CR, Dunderdale CN, Feldpausch M, Iyengar S, Shen G, Baak S, Torriani M, Robbins GK, Lee H, Kwong R, DiCarli M, Adler GK, Grinspoon SK. Randomized Placebo-Controlled Trial to Evaluate Effects of Eplerenone on Myocardial Perfusion and Function Among Persons With Human Immunodeficiency Virus (HIV)-Results From the MIRACLE HIV Study. Clin Infect Dis. 2023 Oct 13;77(8):1166-1175. doi: 10.1093/cid/ciad310. |
Placebo twice daily along with lifestyle modification (counseling regarding diet and healthy activity) for 12 months Placebo: Placebo by mouth twice daily Lifestyle Modification: Counseling regarding diet and healthy activity |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Placebo twice daily along with lifestyle modification (counseling regarding diet and healthy activity) for 12 months Placebo: Placebo by mouth twice daily Lifestyle Modification: Counseling regarding diet and healthy activity |
|
|
|
| Primary | Myocardial Perfusion by MRI | Change (value at 12 months minus value at baseline) in myocardial perfusion assessed by myocardial blood flow measured via cardiac magnetic resonance imaging | Analyses performed on data available | Posted | Mean | Standard Deviation | mL/min/g | 12 Months |
|
|
|
|
| Primary | Myocardial Inflammation | Change (value at 12 months minus value at baseline) in myocardial inflammation measured by extracellular mass index (a measure of the inflammation within the heart) via cardiac magnetic resonance imaging | Analyses performed on data available | Posted | Median | Inter-Quartile Range | g/m^2 | 12 Months |
|
|
|
|
| Secondary | Coronary Plaque | Change (value at 12 months minus value at baseline) in coronary plaque measured via coronary computed tomography angiogram assessed by coronary calcium score Scale: minimum 0 to maximum no limit, higher score indicates more plaque | Analyses performed on data available | Posted | Median | Inter-Quartile Range | score on a scale | 12 Months |
|
|
|
|
| Secondary | Markers of Vascular Dysfunction | Change (value at 12 months minus value at baseline) in serum hs-cTnT | Analyses performed on data available | Posted | Median | Inter-Quartile Range | ng/L | 12 Months |
|
|
|
|
| Secondary | Markers of Systemic Inflammation hsIL-6 | Change (value at 12 months minus value at baseline) in plasma hsIL-6 | Analyses performed on data available | Posted | Median | Inter-Quartile Range | pg/mL | 12 Months |
|
|
|
|
| Secondary | Markers of Systemic Inflammation hsCRP | Change (value at 12 months minus value at baseline) in plasma hsCRP | Analyses performed on data available | Posted | Median | Inter-Quartile Range | ng/mL | 12 Months |
|
|
|
|
| Secondary | Markers of Immune Activation MCP-1 | Change (value at 12 months minus value at baseline) in plasma MCP-1 | Analyses performed on data available | Posted | Median | Inter-Quartile Range | pg/mL | 12 Months |
|
|
|
|
| Secondary | Markers of Immune Activation sCD163 | Change (value at 12 months minus value at baseline) in plasma sCD163 | Analyses performed on data available | Posted | Median | Inter-Quartile Range | ng/mL | 12 Months |
|
|
|
|
| Secondary | Markers of Subclinical Injury | Change (value at 12 months minus value at baseline) in serum NT-proBNP | Analyses performed on data available | Posted | Median | Inter-Quartile Range | ng/L | 12 Months |
|
|
|
|
| Secondary | Markers of Fibrosis | Change (value at 12 months minus value at baseline) in myocardial fibrosis measured by T1 (a signal intensity that measures fibrosis) via cardiac magnetic resonance imaging | Analyses performed on data available | Posted | Median | Inter-Quartile Range | ms | 12 Months |
|
|
|
|
| Secondary | Arterial Inflammation | Percentage change (value at 12 months minus value at baseline) in target to background ratio (a measure of arterial inflammation) of the index vessel measured via positron emission tomography/computed tomography | Analyses performed on data available as part of a substudy. | Posted | Median | Inter-Quartile Range | percentage change | 12 Months |
|
|
|
|
| Secondary | Markers of Arterial Inflammation | Change (value at 12 months minus value at baseline) in plasma LpPLA2 | Analyses performed on data available as part of a substudy. | Posted | Median | Inter-Quartile Range | ng/mL | 12 Months |
|
|
|
|
| Secondary | Assessment of Cardiac Structure by Left Ventricular Mass on Cardiac Imaging | Change (value at 12 months minus value at baseline) in left ventricular mass on cardiac magnetic resonance imaging | Analyses performed on data available | Posted | Median | Inter-Quartile Range | g | 12 Months |
|
|
|
|
| Secondary | Assessment of Cardiac Systolic Function Via Cardiac Imaging | Change (value at 12 months minus value at baseline) in global circumferential strain (GCS) on cardiac magnetic resonance imaging | Analyses performed on data available | Posted | Median | Inter-Quartile Range | percentage GCS | 12 Months |
|
|
|
|
| Secondary | Assessment of Cardiac Diastolic Function Via Cardiac Imaging | Change (value at 12 months minus value at baseline) in left ventricular end diastolic volume on cardiac magnetic resonance imaging | Posted | Mean | Standard Deviation | mL | 12 Months |
|
|
|
|
| 1 |
| 20 |
| 1 |
| 20 |
| 12 |
| 20 |
| EG001 | Placebo | Placebo twice daily along with lifestyle modification (counseling regarding diet and healthy activity) for 12 months Placebo: Placebo by mouth twice daily Lifestyle Modification: Counseling regarding diet and healthy activity | 0 | 20 | 0 | 20 | 11 | 20 |
|
| Gastrointestinal Symptoms | Gastrointestinal disorders | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Upper Respiratory Infection | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Other Infection | Infections and infestations | Non-systematic Assessment |
|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Cardiovascular Symptoms | Cardiac disorders | Non-systematic Assessment |
|
| Injuries | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Other Respiratory Symptoms | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Urinary Volume Increase | Renal and urinary disorders | Non-systematic Assessment |
|
| Underwent Non-Cardiac Elective Procedure | Surgical and medical procedures | Non-systematic Assessment |
|
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| D014652 |
| Vascular Diseases |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |