Detection of Diffuse Scar in Patients With Diabetes
|ClinicalTrials.gov 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
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type II||Drug: Eplerenone Drug: Placebo||Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Comprehensive Stress-Perfusion Cardiac MRI Assessment of Diabetic Cardiomyopathy: Prognostic Role of the Fibrotic Index|
|Study Start Date :||August 2013|
|Estimated Primary Completion Date :||August 2017|
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||
- All cause mortality, cardiovascular death, myocardial infarction or stroke [ Time Frame: 5 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|