Mineralocorticoid Receptor Antagonism Clinical Evaluation in Atherosclerosis 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 Spironolactone 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.
Spironolactone 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 Spironolactone in people with diabetes and atherosclerotic disease.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
|Official Title:||Mineralocorticoid Receptor Antagonism Clinical Evaluation in Atherosclerosis Trial|
- Percent change in atheroma volume (PAV) in the thoracic aorta of Spironolactone vs. placebo [ Time Frame: 56 weeks ]
- Central aortic blood pressure of Spironolactone vs. placebo. [ Time Frame: 56 weeks ]
- 24-hour mean systolic blood pressure of Spironolactone vs. placebo [ Time Frame: 56 weeks ]
- Pulse wave velocity (PWV) of Spironolactone vs. placebo [ Time Frame: 56 weeks ]
- Measures of insulin resistance (HOMA-IR) of Spironolactone vs. placebo [ Time Frame: 56 weeks ]
|Study Start Date:||January 2016|
|Estimated Study Completion Date:||December 2021|
|Estimated Primary Completion Date:||December 2021 (Final data collection date for primary outcome measure)|
Patients will be given Spironolactone 12.5 mg on week 0 (visit 2). Patients will be escalated to 25 mg daily Spironolactone or maximal tolerated dose over a 4-week period. Patients will continue treatment for an additional 48 weeks.
Other Name: Aldactone
Placebo Comparator: Placebo
Please refer to this study by its ClinicalTrials.gov identifier: NCT02169089
|Contact: Steve Sawickifirstname.lastname@example.org|
|United States, Maryland|
|University of Maryland||Recruiting|
|Baltimore, Maryland, United States, 21201|
|Principal Investigator: Sanjay Rajagopalan, MD|
|Principal Investigator:||Sanjay Rajagopalan, MD||University of Maryland|