| Outcome Measures: |
Primary: Safety - Number of Participants With Serum Potassium >6.5 mEq/L, The number of participants who had serum potassium \>6.5 mEq/L was assessed by treatment arm., 0 - 40 weeks|Safety - Participants With Serious Hypotension, The number of participants experiencing serious hypotension, defined as hypotension requiring hospitalization or ED visit and not attributable to overt sepsis, acute myocardial infarction, or other cardiovascular event (e.g. aortic dissection)., 0 - 40 weeks|Study Drug Tolerability, Tolerability is defined as number of participants who experienced permanent study drug discontinuation or dose reduction., 0 - 36 weeks|Efficacy - Change in Mitral Annular E' Velocity, Change in mitral annular E' velocity measured using Tissue Doppler Index (TDI) echocardiography. Efficacy outcomes were considered exploratory with a goal of detecting signals rather than clearly demonstrating efficacy., Baseline to 36 weeks|Feasibility of Conducting a Full-scale Mortality-powered Trial, An objective of this study is to assess the feasibility of conducting a full-scale mortality-powered trial. Feasibility assessed based on recruitment, dropout and loss to follow-up rates., 0 - 40 weeks | Secondary: Safety - Number of Participants With Serious Hyperkalemia, Number of patients with serious hyperkalemia requiring hospitalization, emergency/unscheduled dialysis or resin therapy, 0 - 40 weeks|Safety - Hyperkalemia Requiring Adjustment in Treatment, Hyperkalemia requiring adjustment in dialysate potassium concentration, or discontinuation of study medication, 0 - 40 weeks|Safety - Inter- or Intra-dialytic Hypotension, Inter- or intra-dialytic hypotension defined as: 1. Inter-dialytic: systolic blood pressure \<90 mm Hg or inter-dialytic hypotension requiring adjustment in anti-hypertensive medications or treatment in a hospital or emergency room. 2. Intra-dialytic: systolic blood pressure \<80 mm Hg during ≥3 dialysis sessions per 30-day period or treatment for either hypotension or symptoms of hypotension during ≥3 dialysis sessions per 30-day period, 0 - 40 weeks|Safety - Cardiovascular Death, Number of Cardiovascular deaths defined as death due to myocardial infarction, congestive heart failure, cardiac valvular disease, arrhythmia, sudden death, stroke, or peripheral arterial disease, 0 - 40 weeks|Efficacy - Secondary Cardiac Outcome Measure - Left Ventricular Ejection Fraction (LVEF), Secondary outcome measures include other echocardiographic markers of systolic and diastolic function • Change in left ventricular ejection fraction between Baseline and 36 weeks, Baseline - 36 weeks|Efficacy - Secondary Cardiac Outcome Measures Left Ventricular Mass Index (LVMI), Secondary outcome measures include other echocardiographic markers of systolic and diastolic function, • Change in left ventricular mass index (LVMI) between baseline and 36 weeks, Baseline - 36 weeks|Efficacy - Secondary Cardiac Outcome Measures - Ratio of Mitral Peak Velocity to Diastolic Mitral Annular Velocity (E/E'), Secondary outcome measures include other echocardiographic markers of systolic and diastolic function, • E/E' is the ratio of mitral peak velocity of early filling (E) to early diastolic mitral annular velocity (E'), Baseline - 36 weeks|Efficacy - Secondary Cardiac Outcome Measures - Left Ventricular Global Longitudinal Strain (LVGLS), Secondary outcome measures include other echocardiographic markers of systolic and diastolic function, • Change in myocardial strain and strain rate between baseline and 36 weeks, Baseline - 36 weeks|Safety - Combined Incidence of Potassium >6.5 mEq/L or Serious Hyperkalemia, The number of participants who had serum potassium \>6.5 mEq/L or serious hyperkalemia was assessed by treatment arm., 0 - 40 Weeks
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| Locations: |
The George Washington University, Washington, District of Columbia, 20037, United States|Brigham and Women's Hospital, Boston, Massachusetts, 02120, United States|Vanderbilt University Medical Center, Nashville, Tennessee, 37232, United States|Kidney Research Institute, University of Washington, Seattle, Washington, 98104, United States
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