Detection of Diffuse Scar in Patients With Diabetes
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Screening
|Official Title:||Comprehensive Stress-Perfusion Cardiac MRI Assessment of Diabetic Cardiomyopathy: Prognostic Role of the Fibrotic Index|
- All cause mortality, cardiovascular death, myocardial infarction or stroke [ Time Frame: 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||August 2013|
|Estimated Primary Completion Date:||August 2017 (Final data collection date for primary outcome measure)|
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.
Eplerenone 25 mg daily for 6 months
|Placebo Comparator: Sugar pill||Drug: Placebo|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01794091
|Contact: Raymond Y Kwong, MD MPHfirstname.lastname@example.org|
|United States, Massachusetts|
|Brigham and Women's Hospital||Not yet recruiting|
|Boston, Massachusetts, United States, 02114|