Mineralocorticoid Receptor Antagonism Clinical Evaluation in Atherosclerosis Add-On
Status:
Unknown status
Trial end date:
2018-07-31
Target enrollment:
Participant gender:
Summary
Patiromer add-on to a mineralocorticoid receptor antagonist (MRA) in patients with Type 2
diabetes mellitus and chronic kidney disease (CKD) will reduce blood pressure and left
ventricular (LV) mass to a greater extent compared to patients with MRA alone and favorably
affect key secondary hemodynamic and inflammatory variables including atherosclerosis
progression.
Atherosclerosis is the leading cause of morbidity and mortality in Type II diabetes. A cell
type called the monocyte/macrophage is critical to development and complications of
atherosclerosis.
This project will evaluate the effectiveness of a medication called Spironolactone in
addition to Patiromer in preventing atherosclerosis in Type II diabetes through its effects
on cells such as the monocyte. Spironolactone has been demonstrated to be effective for the
treatment of patients after a heart attack and stroke. The investigators will evaluate the
impact of Spironolactone in combination with Patiromer in reducing atherosclerosis plaque and
additionally evaluate its potential in changing inflammation.
The investigators envision that a strategy of simultaneously probing effect of a drug
combined with analysis of mechanisms of action and predictive response will likely provide
key information with which to design hard event (heart attack, stroke etc.) based trials.