Detection of Diffuse Scar in Patients With Diabetes
|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 MPHemail@example.com|
|United States, Massachusetts|
|Brigham and Women's Hospital||Not yet recruiting|
|Boston, Massachusetts, United States, 02114|