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Trial record 59 of 112 for:    EPLERENONE

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

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ClinicalTrials.gov Identifier: NCT02740179
Recruitment Status : Recruiting
First Posted : April 15, 2016
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Steven K. Grinspoon, MD, Massachusetts General Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
HIV Drug: Eplerenone Drug: Placebo Behavioral: Lifestyle Modification Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mineralocorticoid Receptor Antagonism for Cardiovascular Health in HIV--The MIRACLE HIV Study
Study Start Date : January 2017
Estimated Primary Completion Date : January 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Eplerenone

Arm Intervention/treatment
Experimental: Eplerenone
Eplerenone 50 mg twice daily along with lifestyle modification (counseling regarding diet and healthy activity) for 12 months
Drug: Eplerenone
Eplerenone 50mg by mouth twice daily

Behavioral: Lifestyle Modification
Counseling regarding diet and healthy activity

Placebo Comparator: Placebo
Placebo twice daily along with lifestyle modification (counseling regarding diet and healthy activity) for 12 months
Drug: Placebo
Placebo by mouth twice daily

Behavioral: Lifestyle Modification
Counseling regarding diet and healthy activity




Primary Outcome Measures :
  1. Coronary Flow Reserve [ Time Frame: 12 Months ]
    Coronary Flow Reserve measured via Cardiac Positron Emission Tomography

  2. Myocardial Inflammation [ Time Frame: 12 Months ]
    Myocardial Inflammation measured by extracellular volume fraction via Cardiac Magnetic Resonance Imaging


Secondary Outcome Measures :
  1. Coronary Plaque [ Time Frame: 12 Months ]
    Coronary Plaque measured via Coronary Computed Tomography Angiogram

  2. Markers of Vascular Dysfunction [ Time Frame: 12 Months ]
  3. Markers of Systemic Inflammation [ Time Frame: 12 Months ]
  4. Markers of Immune Activation [ Time Frame: 12 Months ]
  5. Markers of Subclinical Injury [ Time Frame: 12 Months ]
  6. Markers of Fibrosis [ Time Frame: 12 Months ]
  7. Arterial Inflammation [ Time Frame: 12 Months ]
    Arterial Inflammation measured via Aortic Positron Emission Tomography/Computed Tomography

  8. Markers of Arterial Inflammation [ Time Frame: 12 Months ]


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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02740179


Contacts
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Contact: Suman Srinivasa, MD, MS 6177269109 ssrinivasa@mgh.harvard.edu
Contact: Steven K. Grinspoon, MD 6177269109 sgrinspoon@mgh.harvard.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Suman Srinivasa, MD, MS    617-724-9109    ssrinivasa@mgh.harvard.edu   
Contact: Steven K. Grinspoon, MD    6177249109    sgrinspoon@mgh.harvard.edu   
Sponsors and Collaborators
Massachusetts General Hospital

Publications:
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Responsible Party: Steven K. Grinspoon, MD, Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02740179     History of Changes
Other Study ID Numbers: 2016P000464
First Posted: April 15, 2016    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Keywords provided by Steven K. Grinspoon, MD, Massachusetts General Hospital:
Eplerenone
Cardiovascular Disease
Mineralocorticoid Receptor Antagonist
Coronary Vasculature
Myocardial Inflammation
Myocardial Fibrosis
Atherosclerosis
Aldosterone
Additional relevant MeSH terms:
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Eplerenone
Cardiovascular Diseases
Mineralocorticoids
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Antihypertensive Agents
Hormones