Mineralocorticoid Receptor Antagonism Clinical Evaluation in Atherosclerosis Trial
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02169089|
Recruitment Status : Recruiting
First Posted : June 20, 2014
Last Update Posted : March 7, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Atherosclerosis||Drug: Spironolactone Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||130 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Mineralocorticoid Receptor Antagonism Clinical Evaluation in Atherosclerosis Trial|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
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
- 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 ]
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): NCT02169089
|Contact: Heather Conger||216-866-6550||Heather.Conger2@uhhospitals.org|
|Contact: Steven Sawickiemail@example.com|
|United States, Ohio|
|University Hospitals Cleveland Medical Center||Recruiting|
|Cleveland, Ohio, United States, 44106|
|Contact: Heather Conger 216-866-6550 firstname.lastname@example.org|
|Contact: Steven Sawicki 216-844-7188 email@example.com|
|Principal Investigator: Sanjay Rajagopalan, MD|
|Sub-Investigator: Mirela Dobre, MD|
|Principal Investigator:||Sanjay Rajagopalan||Chief, Cardiovascular Medicine|