Diabetes Mellitus, Type IIPhase 4NCT01794091
Detection of Diffuse Scar in Patients With Diabetes
A Phase 4 study testing Eplerenone in people with Diabetes Mellitus, Type II, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
People with diabetes are at an increased risk of heart attacks and heart failure, and it is important to be able to treat people with diabetes who are at risk for heart disease to prevent these outcomes. This study is looking at the importance of "diffuse scar tissue" that is found in the heart of diabetic people. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type II
- What is being tested?
- Eplerenone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Aug 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetes mellitus, type II
- Age >= 40 years
- UKPDS 10 year Risk Score > 15%
- Low risk stress test (defined explicitily in our protocol)
- Included in Phase I
- Systolic blood pressure > 140 mmHg on two occasions (at the initial nuclear stress test and at the index cardiac MRI)
Who cannot join
- suspected or confirmed myocarditis or infiltrative disease (including hemochromatosis, sarcoid, or amyloid)
- history of prior MI or coronary revascularization (by Q waves on electrocardiogram in 2 contiguous leads or by clinical history)
- clinical HF (with prior hospital admission for HF or documentation of reduced LV ejection fraction after index CMR)
- metallic hazards
- hematocrit < 30% (within 1 year of nuclear stress test) or history of active bleeding (within 3 months of stress test)
- estimated GFR (by Modified Diet in Renal Disease) < 45 ml/min/1.73m2 (within 2 weeks of planned CMR)
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- pregnancy
- severe non-cardiac illness that or prognosis (e.g., end stage liver disease, malignancy, advanced HIV/AIDS)
- For PHASE 2:
- Concomitant cytochrome P450 (CYP3A4) inhibitors or inducers;
- Concomitant potassium supplementation or potassium sparing diuretics;
- Concomitant use of both ACE inhibitor and ARB therapy (at any dose);
- Renal dysfunction (GFR < 50 ml/min or serum creatinine > 1.5 mg/dL (as assessed at time of index CMR);
- Any urine microalbuminuria (as assessed at time of index CMR);
- Baseline (pre-therapy) serum potassium > 5.0 mEq/L;
- Lack of reliable telephone contact number for relaying results or the need to discontinue drug therapy;
- Age > 75 years (given the tendency toward renal insufficiency not captured by GFR, dehydration and/or concomitant illness)
- Women able to become pregnant (given the undefined risk of eplerenone therapy in pregnant women and newborns).
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02114
About this study
Official title: Comprehensive Stress-Perfusion Cardiac MRI Assessment of Diabetic Cardiomyopathy: Prognostic Role of the Fibrotic Index
People with diabetes are at an increased risk of heart attacks and heart failure, and it is important to be able to treat people with diabetes who are at risk for heart disease to prevent these outcomes. This study is looking at the importance of "diffuse scar tissue" that is found in the heart of diabetic people. We have discovered a way to detect diffuse scar tissue by cardiac MRI, a non-invasive test. In this study, we do cardiac MRI on diabetics with low risk stress test results and follow them for 5 years to see if the measure of scar tissue in the heart by MRI is related to events. If this study is positive, we will be able to use cardiac MRI scar tissue measurements to target those patients with diabetes who are at highest risk.
Read the detailed description
This study will be conducted in TWO (2) PHASES:
Phase 1: Prospective cohort study of patients with diabetes mellitus, in which index cardiac MRI will be done after screening to determine FIBROTIC INDEX. Patients are subsequently followed for 5 years for a primary endpoint (composite cardiovascular event).
Phase 2: Of the patients with "HIGH" FIBROTIC INDEX, 50 patients will be randomly selected and randomized 1:1 to placebo:eplerenone 25 mg daily for 6 months, and a repeat cardiac MRI will be done to assess the fibrotic index post-treatment.
Phase 2 is a PILOT study of 50 patients.
The inclusion/exclusion criteria for the different phases is shown below.
- Conditions
- Diabetes Mellitus, Type II
- Being tested
- Eplerenone, Placebo
- Keywords
- Cardiac Magnetic Resonance Imaging, Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EplerenoneDrug
Eplerenone 25 mg daily for 6 months
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Eplerenone | Experimental | In a subgroup of 50 patients, 25 will be randomized to eplerenone to assess effects on fibrotic index pre- and post-6 months of therapy. Receives: Drug: Eplerenone |
| Sugar pill | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality, cardiovascular death, myocardial infarction or stroke
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2013 (estimated)
- Study startAug 2013 (estimated)
- Primary completionAug 2017 (estimated)
- Study completionAug 2017 (estimated)
Why it stopped: No participants were enrolled in the trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type IIStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raymond Y. Kwong, MD, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01794091
- Sponsor's protocol ID
- Fibrotic Index in Diabetics
- Status last verified
- Nov 2025
- First submitted
- 15 Feb 2013
- Last updated
- 6 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Stress-Perfusion Cardiac MRI Assessment of Diabetic Cardiomyopathy: Prognostic Role of the Fibrotic Index
- ClinicalTrials.gov ID
- NCT01794091
- Acronym / sponsor ID
- Fibrotic Index in Diabetics
- Conditions
- Diabetes Mellitus, Type II
- Keywords
- Cardiac Magnetic Resonance Imaging, Diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants were enrolled in the trial.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Aug 2013 (estimated)
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 18 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
People with diabetes are at an increased risk of heart attacks and heart failure, and it is important to be able to treat people with diabetes who are at risk for heart disease to prevent these outcomes. This study is looking at the importance of "diffuse scar tissue" that is found in the heart of diabetic people. We have discovered a way to detect diffuse scar tissue by cardiac MRI, a non-invasive test. In this study, we do cardiac MRI on diabetics with low risk stress test results and follow them for 5 years to see if the measure of scar tissue in the heart by MRI is related to events. If this study is positive, we will be able to use cardiac MRI scar tissue measurements to target those patients with diabetes who are at highest risk.
Detailed description
This study will be conducted in TWO (2) PHASES:
Phase 1: Prospective cohort study of patients with diabetes mellitus, in which index cardiac MRI will be done after screening to determine FIBROTIC INDEX. Patients are subsequently followed for 5 years for a primary endpoint (composite cardiovascular event).
Phase 2: Of the patients with "HIGH" FIBROTIC INDEX, 50 patients will be randomly selected and randomized 1:1 to placebo:eplerenone 25 mg daily for 6 months, and a repeat cardiac MRI will be done to assess the fibrotic index post-treatment.
Phase 2 is a PILOT study of 50 patients.
The inclusion/exclusion criteria for the different phases is shown below.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eplerenone | Experimental | Drug: EplerenoneIn a subgroup of 50 patients, 25 will be randomized to eplerenone to assess effects on fibrotic index pre- and post-6 months of therapy. |
| Sugar pill | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diabetes mellitus, type II
- Age >= 40 years
- UKPDS 10 year Risk Score > 15%
- Low risk stress test (defined explicitily in our protocol)
- Included in Phase I
Key exclusion criteria (18 listed)
- suspected or confirmed myocarditis or infiltrative disease (including hemochromatosis, sarcoid, or amyloid)
- history of prior MI or coronary revascularization (by Q waves on electrocardiogram in 2 contiguous leads or by clinical history)
- clinical HF (with prior hospital admission for HF or documentation of reduced LV ejection fraction after index CMR)
- metallic hazards
- hematocrit < 30% (within 1 year of nuclear stress test) or history of active bleeding (within 3 months of stress test)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EplerenoneEplerenone 25 mg daily for 6 months | Drug | Eplerenone |
| Placebo | Drug | Sugar pill |
Primary outcome
All cause mortality, cardiovascular death, myocardial infarction or stroke
Time frame: 5 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Eplerenone in people with Diabetes Mellitus, Type II, run by Brigham and Women's 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 6 inclusion and 18 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: withdrawn, as of the sponsor's last update on 6 Nov 2025. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
All cause mortality, cardiovascular death, myocardial infarction or stroke (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Nov 2025.