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.|
|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|