Detection of Diffuse Scar in Patients With Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01794091
Recruitment Status : Unknown
Verified February 2013 by Raymond Y. Kwong, MD, Brigham and Women's Hospital.
Recruitment status was:  Not yet recruiting
First Posted : February 18, 2013
Last Update Posted : February 18, 2013
Information provided by (Responsible Party):
Raymond Y. Kwong, MD, Brigham and Women's Hospital

February 15, 2013
February 18, 2013
February 18, 2013
August 2013
August 2017   (Final data collection date for primary outcome measure)
All cause mortality, cardiovascular death, myocardial infarction or stroke [ Time Frame: 5 years ]
Same as current
No Changes Posted
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Detection of Diffuse Scar in Patients With Diabetes
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.

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.

Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Screening
Diabetes Mellitus, Type II
  • Drug: Eplerenone
    Eplerenone 25 mg daily for 6 months
  • Drug: Placebo
  • Experimental: Eplerenone
    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.
    Intervention: Drug: Eplerenone
  • Placebo Comparator: Sugar pill
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
Not Provided
August 2017   (Final data collection date for primary outcome measure)

For PHASE I (Prospective Cohort Study to determine prognostic value of fibrotic index)

Inclusion Criteria:

  • Diabetes mellitus, type II
  • Age >= 40 years
  • UKPDS 10 year Risk Score > 15%
  • Low risk stress test (defined explicitily in our protocol)

Exclusion Criteria:

  • 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)
  • pregnancy
  • severe non-cardiac illness that or prognosis (e.g., end stage liver disease, malignancy, advanced HIV/AIDS)

For PHASE 2:

Inclusion Criteria:

  • Included in Phase I
  • Systolic blood pressure > 140 mmHg on two occasions (at the initial nuclear stress test and at the index cardiac MRI)

Exclusion criteria:

  1. Concomitant cytochrome P450 (CYP3A4) inhibitors or inducers;
  2. Concomitant potassium supplementation or potassium sparing diuretics;
  3. Concomitant use of both ACE inhibitor and ARB therapy (at any dose);
  4. Renal dysfunction (GFR < 50 ml/min or serum creatinine > 1.5 mg/dL (as assessed at time of index CMR);
  5. Any urine microalbuminuria (as assessed at time of index CMR);
  6. Baseline (pre-therapy) serum potassium > 5.0 mEq/L;
  7. Lack of reliable telephone contact number for relaying results or the need to discontinue drug therapy;
  8. Age > 75 years (given the tendency toward renal insufficiency not captured by GFR, dehydration and/or concomitant illness)
  9. Women able to become pregnant (given the undefined risk of eplerenone therapy in pregnant women and newborns).
Sexes Eligible for Study: All
40 Years to 75 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Fibrotic Index in Diabetics
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Raymond Y. Kwong, MD, Brigham and Women's Hospital
Brigham and Women's Hospital
Not Provided
Not Provided
Brigham and Women's Hospital
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP