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
Cite this record
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
On this page
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.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Myocardial Perfusion by PET | 12 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. |
| Primary | Myocardial Perfusion by MRI | 12 Months | Change (value at 12 months minus value at baseline) in myocardial perfusion assessed by myocardial blood flow measured via cardiac magnetic resonance imaging |
| Primary | Myocardial Inflammation | 12 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 |
| Secondary | Coronary Plaque | 12 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 |
| Secondary | Markers of Vascular Dysfunction | 12 Months | Change (value at 12 months minus value at baseline) in serum hs-cTnT |
| Secondary | Markers of Systemic Inflammation hsIL-6 | 12 Months | Change (value at 12 months minus value at baseline) in plasma hsIL-6 |
| Secondary | Markers of Systemic Inflammation hsCRP | 12 Months | Change (value at 12 months minus value at baseline) in plasma hsCRP |
| Secondary | Markers of Immune Activation MCP-1 | 12 Months | Change (value at 12 months minus value at baseline) in plasma MCP-1 |
| Secondary | Markers of Immune Activation sCD163 | 12 Months | Change (value at 12 months minus value at baseline) in plasma sCD163 |
| Secondary | Markers of Subclinical Injury | 12 Months | Change (value at 12 months minus value at baseline) in serum NT-proBNP |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Myocardial Perfusion by PET | 12 Months | Analyses performed on data available | unitless | MEAN |
| PRIMARY | Myocardial Perfusion by MRI | 12 Months | Analyses performed on data available | mL/min/g | MEAN |
| PRIMARY | Myocardial Inflammation | 12 Months | Analyses performed on data available | g/m^2 | MEDIAN |
| SECONDARY | Coronary Plaque | 12 Months | Analyses performed on data available | score on a scale | MEDIAN |
| SECONDARY | Markers of Vascular Dysfunction | 12 Months | Analyses performed on data available | ng/L | MEDIAN |
| SECONDARY | Markers of Systemic Inflammation hsIL-6 | 12 Months | Analyses performed on data available | pg/mL | MEDIAN |
| SECONDARY | Markers of Systemic Inflammation hsCRP | 12 Months | Analyses performed on data available | ng/mL | MEDIAN |
| SECONDARY | Markers of Immune Activation MCP-1 | 12 Months | Analyses performed on data available | pg/mL | MEDIAN |
| SECONDARY | Markers of Immune Activation sCD163 | 12 Months | Analyses performed on data available | ng/mL | MEDIAN |
| SECONDARY | Markers of Subclinical Injury | 12 Months | Analyses performed on data available | ng/L | MEDIAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Myocardial Perfusion by PET | Eplerenone | 0.01 | Standard Deviation 0.64 | unitless | |
| Myocardial Perfusion by PET | Placebo | -0.07 | Standard Deviation 0.48 | unitless | |
| Myocardial Perfusion by MRI | Eplerenone | 0.09 | Standard Deviation 0.56 | mL/min/g | |
| Myocardial Perfusion by MRI | Placebo | -0.53 | Standard Deviation 0.68 | mL/min/g | |
| Myocardial Inflammation | Eplerenone | 0.9 | Inter-Quartile Range -2.3 to 4.3 | g/m^2 | |
| Myocardial Inflammation | Placebo | -0.7 | Inter-Quartile Range -2.2 to -0.1 | g/m^2 | |
| Coronary Plaque | Eplerenone | 0 | Inter-Quartile Range 0 to 6 | score on a scale | |
| Coronary Plaque | Placebo | 5 | Inter-Quartile Range 0 to 41 | score on a scale | |
| Markers of Vascular Dysfunction | Eplerenone | 0.00 | Inter-Quartile Range -0.13 to 0.00 | ng/L | |
| Markers of Vascular Dysfunction | Placebo | 0.00 | Inter-Quartile Range 0.00 to 0.74 | ng/L |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Eplerenone | 20 | |
| Overall Study | STARTED | Placebo | 20 | |
| Overall Study | COMPLETED | Eplerenone | 14 | |
| Overall Study | COMPLETED | Placebo | 19 | |
| Overall Study | NOT COMPLETED | Eplerenone | 6 | |
| Overall Study | NOT COMPLETED | Placebo | 1 |
Source ClinicalTrials.gov
Adverse events24
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Dizziness | Cardiac disorders | Eplerenone | 4 | 20 | |
| other | Dizziness | Cardiac disorders | Placebo | 0 | 20 | |
| other | Gastrointestinal Symptoms | Gastrointestinal disorders | Eplerenone | 4 | 20 | |
| other | Gastrointestinal Symptoms | Gastrointestinal disorders | Placebo | 3 | 20 | |
| other | Rash | Skin and subcutaneous tissue disorders | Eplerenone | 3 | 20 | |
| other | Rash | Skin and subcutaneous tissue disorders | Placebo | 1 | 20 | |
| other | Upper Respiratory Infection | Respiratory, thoracic and mediastinal disorders | Eplerenone | 3 | 20 | |
| other | Upper Respiratory Infection | Respiratory, thoracic and mediastinal disorders | Placebo | 1 | 20 | |
| other | Other Infection | Infections and infestations | Eplerenone | 5 | 20 | |
| other | Other Infection | Infections and infestations | Placebo | 6 | 20 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Eplerenone | 1 | 20 |
| Total, all-cause mortality | Placebo | 0 | 20 |
| Total, other adverse events | Eplerenone | 12 | 20 |
| Total, other adverse events | Placebo | 11 | 20 |
| Total, serious adverse events | Eplerenone | 1 | 20 |
| Total, serious adverse events | Placebo | 0 | 20 |
Source ClinicalTrials.gov
Papers7
The papers the trial lists on ClinicalTrials.gov.
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.
| Comparison | Source |
|---|---|
| Eplerenone vs Placebo: deaths from any cause | Trial comparisons |
| Eplerenone vs Placebo: serious adverse events | Trial 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.
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