Evaluation of Patiromer Titration in Heart Failure Patients With Chronic Kidney Disease

Exclusion Criteria

• •1. History of bowel obstruction, swallowing disorders, severe gastrointestinal disorders or major gastrointestinal surgery
• •2. Uncorrected primary severe valvular disease, known obstructive or restrictive cardiomyopathy, uncontrolled or hemodynamically unstable arrhythmia
• •3. Coronary-artery bypass graft, percutaneous intervention (e.g., cardiac, cerebrovascular, aortic), or major surgery including thoracic and cardiac, within 3 months prior to baseline or anticipated need during study participation
• •4. Heart transplant recipient, or anticipated need for transplant during study participation
• •5. Any of the following events having occurred within 2 months prior to baseline: unstable angina as judged by the Investigator, unresolved acute coronary syndrome, transient ischemic attack or stroke
• •6. Current dialysis participant, or anticipated need for dialysis during study participation
• •7. Prior kidney transplant, or anticipated need for transplant during study participation
• •8. Metastatic, late-stage or end-stage cancer with \< 12 months life expectancy or at risk for tumor lysis syndrome
• •9. History of alcoholism or drug/chemical abuse within 1 year
• •10. Sustained systolic blood pressure \> 180 or \< 90 mmHg
• •11. Liver enzymes \[alanine aminotransferase (ALT), aspartate aminotransferase (AST)\] \> 3 times upper limit of normal
• •12. Loop and thiazide diuretics that have not been stable for at least 21 days prior to baseline or not anticipated to remain stable during study participation
• •13. Use of any intravenous cardiac medications within 21 days prior to baseline, or their anticipated need during study participation
• •14. Current use of polymer-based drugs (e.g., sevelamer, sodium polystyrene sulfonate, colesevelam, colestipol), phosphate binders (e.g., lanthanum carbonate), or other potassium binders, or their anticipated need during study participation
• •15. Use of potassium sparing medication including aldosterone antagonists or potassium supplements in the last 21 days prior to baseline
• •16. Use of any investigational medication within 30 days or 5 half-lives, whichever is longer, prior to baseline
• •17. Participants who have taken investigational product in this study, or a previous patiromer study
• •18. Inability to consume the study medication, or, in the opinion of the Investigator, inability to comply with the protocol
• •19. In the opinion of the Investigator, any medical condition, uncontrolled systemic disease, serious intercurrent illness, or extenuating circumstance occurring or persisting, within 30 days prior to baseline, that would significantly decrease study compliance or jeopardize the safety of the participant or affect the validity of the trial results