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Trial · NCT02740179

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

NCT02740179, Not applicable, Completed, Massachusetts General Hospital; results first posted 2023-06-02

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Effects of Eplerenone on Cardiovascular Disease in HIV (MIRACLE HIV Study). Trials, record NCT02740179. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02740179

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Effects of Eplerenone on Cardiovascular Disease in HIV (MIRACLE HIV Study)
NCT number
NCT02740179
Status
Completed
Phases
Not applicable
Enrollment
40 participants, actual
Lead sponsor
Massachusetts General Hospital
Conditions
HIV
Interventions
Eplerenone, Placebo, Lifestyle Modification
First posted
2016-04-15
Last updated
2023-06-06
Results first posted
2023-06-02

Source ClinicalTrials.gov

Registered outcomes16

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryMyocardial Perfusion by PET12 Months
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.
PrimaryMyocardial Perfusion by MRI12 MonthsChange (value at 12 months minus value at baseline) in myocardial perfusion assessed by myocardial blood flow measured via cardiac magnetic resonance imaging
PrimaryMyocardial Inflammation12 Months
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
SecondaryCoronary Plaque12 Months
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
SecondaryMarkers of Vascular Dysfunction12 MonthsChange (value at 12 months minus value at baseline) in serum hs-cTnT
SecondaryMarkers of Systemic Inflammation hsIL-612 MonthsChange (value at 12 months minus value at baseline) in plasma hsIL-6
SecondaryMarkers of Systemic Inflammation hsCRP12 MonthsChange (value at 12 months minus value at baseline) in plasma hsCRP
SecondaryMarkers of Immune Activation MCP-112 MonthsChange (value at 12 months minus value at baseline) in plasma MCP-1
SecondaryMarkers of Immune Activation sCD16312 MonthsChange (value at 12 months minus value at baseline) in plasma sCD163
SecondaryMarkers of Subclinical Injury12 MonthsChange (value at 12 months minus value at baseline) in serum NT-proBNP

Outcomes16

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYMyocardial Perfusion by PET12 MonthsAnalyses performed on data availableunitlessMEAN
PRIMARYMyocardial Perfusion by MRI12 MonthsAnalyses performed on data availablemL/min/gMEAN
PRIMARYMyocardial Inflammation12 MonthsAnalyses performed on data availableg/m^2MEDIAN
SECONDARYCoronary Plaque12 MonthsAnalyses performed on data availablescore on a scaleMEDIAN
SECONDARYMarkers of Vascular Dysfunction12 MonthsAnalyses performed on data availableng/LMEDIAN
SECONDARYMarkers of Systemic Inflammation hsIL-612 MonthsAnalyses performed on data availablepg/mLMEDIAN
SECONDARYMarkers of Systemic Inflammation hsCRP12 MonthsAnalyses performed on data availableng/mLMEDIAN
SECONDARYMarkers of Immune Activation MCP-112 MonthsAnalyses performed on data availablepg/mLMEDIAN
SECONDARYMarkers of Immune Activation sCD16312 MonthsAnalyses performed on data availableng/mLMEDIAN
SECONDARYMarkers of Subclinical Injury12 MonthsAnalyses performed on data availableng/LMEDIAN

Results by group32

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Myocardial Perfusion by PETEplerenone0.01Standard Deviation 0.64unitless
Myocardial Perfusion by PETPlacebo-0.07Standard Deviation 0.48unitless
Myocardial Perfusion by MRIEplerenone0.09Standard Deviation 0.56mL/min/g
Myocardial Perfusion by MRIPlacebo-0.53Standard Deviation 0.68mL/min/g
Myocardial InflammationEplerenone0.9Inter-Quartile Range -2.3 to 4.3g/m^2
Myocardial InflammationPlacebo-0.7Inter-Quartile Range -2.2 to -0.1g/m^2
Coronary PlaqueEplerenone0Inter-Quartile Range 0 to 6score on a scale
Coronary PlaquePlacebo5Inter-Quartile Range 0 to 41score on a scale
Markers of Vascular DysfunctionEplerenone0.00Inter-Quartile Range -0.13 to 0.00ng/L
Markers of Vascular DysfunctionPlacebo0.00Inter-Quartile Range 0.00 to 0.74ng/L

Participant flow6

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDEplerenone20
Overall StudySTARTEDPlacebo20
Overall StudyCOMPLETEDEplerenone14
Overall StudyCOMPLETEDPlacebo19
Overall StudyNOT COMPLETEDEplerenone6
Overall StudyNOT COMPLETEDPlacebo1

Adverse events24

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherDizzinessCardiac disordersEplerenone420
otherDizzinessCardiac disordersPlacebo020
otherGastrointestinal SymptomsGastrointestinal disordersEplerenone420
otherGastrointestinal SymptomsGastrointestinal disordersPlacebo320
otherRashSkin and subcutaneous tissue disordersEplerenone320
otherRashSkin and subcutaneous tissue disordersPlacebo120
otherUpper Respiratory InfectionRespiratory, thoracic and mediastinal disordersEplerenone320
otherUpper Respiratory InfectionRespiratory, thoracic and mediastinal disordersPlacebo120
otherOther InfectionInfections and infestationsEplerenone520
otherOther InfectionInfections and infestationsPlacebo620

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityEplerenone120
Total, all-cause mortalityPlacebo020
Total, other adverse eventsEplerenone1220
Total, other adverse eventsPlacebo1120
Total, serious adverse eventsEplerenone120
Total, serious adverse eventsPlacebo020

Papers7

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
26086328BACKGROUNDPubMed
37243345DERIVEDPubMed
37559752DERIVEDPubMed
38090987DERIVEDPubMed
38813261DERIVEDPubMed
40478895DERIVEDPubMed
41994349DERIVEDPubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

ComparisonSource
Eplerenone vs Placebo: deaths from any causeTrial comparisons
Eplerenone vs Placebo: serious adverse eventsTrial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02740179

GET https://conductscience.org/api/trials/v1/NCT02740179/results?page=2