Mineralocorticoid Receptor Antagonism Clinical Evaluation in Atherosclerosis (MIRACULOUS) Trial
Atherosclerotic disease, or hardening of the arteries, is characterized by the thickening of the arterial walls due to fatty deposits in wall and inflammation in the wall of arteries. High cholesterol, high blood pressure, diabetes, obesity and genetics play an important role in developing clinical symptoms of atherosclerosis disease. The complications of advanced atherosclerosis are chronic, slowly progressive and cumulative, resulting in heart attack, stroke and/or death and blockage of arteries.
This study is being done to assess the effectiveness of Eplerenone therapy to slow down the worsening of atherosclerotic disease (hardening of the arteries) in aorta (this is a large vessel coming out of your heart) compared to placebo (look alike sugar pill). This will be checked by comparing before and after therapy magnetic resonance imaging (MRI) pictures of your aortic wall.
Eplerenone is an FDA approved drug used to treat heart failure and in the management of hypertension (high blood pressure), but in this study it is used for another unapproved reason. In this study, we would like to evaluate the effects of Eplerenone in people with diabetes and atherosclerotic disease.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Mineralocorticoid Receptor Antagonism Clinical Evaluation in Atherosclerosis (MIRACULOUS) Trial|
- Percent change in atheroma volume (PAV) in the thoracic aorta of Eplerenone vs. placebo [ Time Frame: 56 weeks ] [ Designated as safety issue: No ]
- Central aortic blood pressure of Eplerenone vs. placebo. [ Time Frame: 56 weeks ] [ Designated as safety issue: No ]
- 24-hour mean systolic blood pressure of Eplerenone vs. placebo [ Time Frame: 56 weeks ] [ Designated as safety issue: No ]
- Pulse wave velocity (PWV) of Eplerenone vs. placebo [ Time Frame: 56 weeks ] [ Designated as safety issue: No ]
- Measures of insulin resistance (HOMA-IR) of Eplerenone vs. placebo [ Time Frame: 56 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||June 2014|
|Estimated Study Completion Date:||September 2016|
|Estimated Primary Completion Date:||September 2016 (Final data collection date for primary outcome measure)|
Patients will be given Eplerenone 25 mg on week 0 (visit 2). Patients will be escalated to 50 mg bid Eplerenone or maximal tolerated dose over a 4-week period. Patients will continue treatment for an additional 48 weeks.
Other Name: Inspra
Placebo Comparator: Placebo
Please refer to this study by its ClinicalTrials.gov identifier: NCT02169089
|Contact: Kylene Broadwateremail@example.com|
|United States, Maryland|
|University of Maryland||Not yet recruiting|
|Baltimore, Maryland, United States, 21201|
|Principal Investigator: Sanjay Rajagopalan, MD|
|Principal Investigator:||Sanjay Rajagopalan, MD||University of Maryland|