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HIVNCT02740179

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

A study testing Eplerenone and Lifestyle Modification in people with HIV, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 40 to 65 years
Conditions the study is for
HIV
What is being tested?
Eplerenone and Lifestyle Modification
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteUnited States
Study dates
Jan 2017to 17 Mar 2022
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Ages 40-65 years
  • Antiretroviral use (ART) >12 months and HIV viral load <100 copies/mL
  • VAT> 110cm2

Who cannot join

  • 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. Stable 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<60 mL/min/1.73m2.
Show all 17Show fewer
  • K > 5.5 mEq/L.
  • Hemoglobin < 10 g/dL.
  • Known liver disease or ALT >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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: 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.

Read the detailed description

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
HIV
Being tested
Eplerenone, Placebo, Lifestyle Modification
Keywords
Eplerenone, Cardiovascular Disease, Mineralocorticoid Receptor Antagonist, Coronary Vasculature, Myocardial Inflammation, Myocardial Fibrosis, Atherosclerosis, Aldosterone
Medical subject headings
Cardiovascular Diseases, Myocarditis, Atherosclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EplerenoneDrug

    Eplerenone 50mg by mouth twice daily

  • PlaceboDrug

    Placebo by mouth twice daily

  • Lifestyle ModificationBehavioural

    Counseling regarding diet and healthy activity

Study groups in NCT02740179
Study groupRoleWhat they receive
EplerenoneExperimentalEplerenone 50 mg twice daily along with lifestyle modification (counseling regarding diet and healthy activity) for 12 months
Receives: Drug: Eplerenone; Behavioral: Lifestyle Modification
PlaceboPlacebo comparatorPlacebo twice daily along with lifestyle modification (counseling regarding diet and healthy activity) for 12 months
Receives: Drug: Placebo; Behavioral: Lifestyle Modification

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 Months

  2. 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

    Measured: 12 Months

  3. 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

    Measured: 12 Months

Secondary outcomes (13)

  1. 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

    Measured: 12 Months

  2. Markers of Vascular Dysfunction

    Change (value at 12 months minus value at baseline) in serum hs-cTnT

    Measured: 12 Months

  3. Markers of Systemic Inflammation hsIL-6

    Change (value at 12 months minus value at baseline) in plasma hsIL-6

    Measured: 12 Months

  4. Markers of Systemic Inflammation hsCRP

    Change (value at 12 months minus value at baseline) in plasma hsCRP

    Measured: 12 Months

  5. Markers of Immune Activation MCP-1

    Change (value at 12 months minus value at baseline) in plasma MCP-1

    Measured: 12 Months

  6. Markers of Immune Activation sCD163

    Change (value at 12 months minus value at baseline) in plasma sCD163

    Measured: 12 Months

  7. Markers of Subclinical Injury

    Change (value at 12 months minus value at baseline) in serum NT-proBNP

    Measured: 12 Months

  8. 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

    Measured: 12 Months

  9. 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

    Measured: 12 Months

  10. Markers of Arterial Inflammation

    Change (value at 12 months minus value at baseline) in plasma LpPLA2

    Measured: 12 Months

  11. 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

    Measured: 12 Months

  12. 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

    Measured: 12 Months

  13. 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

    Measured: 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2016 (estimated)
  2. Study startJan 2017
  3. Primary completion17 Mar 2022
  4. Study completion17 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02740179
Sponsor's protocol ID
2016P000464
Status last verified
Jun 2023
First submitted
7 Apr 2016
Last updated
6 Jun 2023
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 26086328

  • 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.

    PubMed 41994349

  • 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.

    PubMed 40478895

  • 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.

    PubMed 38813261

  • 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.

    PubMed 38090987

  • 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.

    PubMed 37559752

  • 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.

    PubMed 37243345

Questions about this trial

What is this clinical trial studying?

A study testing Eplerenone and Lifestyle Modification in people with HIV, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Myocardial Perfusion by PET (time frame: 12 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02740179, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2023.

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