Patiromer for the Management of Hyperkalemia in Subjects Receiving RAASi Medications for the Treatment of Heart Failure (DIAMOND)

• Status: Completed
• Trial end date: 2021-09-02
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the effects of patiromer compared with placebo on serum K+ in HF patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Relypsa, Inc.; Vifor Pharma, Inc.
• Collaborator: Vifor Pharma

Criteria

Inclusion Criteria:

• Age at least 18 years or greater

• Symptomatic low ejection fraction heart failure (weak heart muscle)

• Receiving any dose of a beta blocker for the treatment of HF (unless not able to tolerate)

• Kidney function not more than mild or moderately impaired

• High blood potassium (>5.0 mEq/L) currently while receiving medications for heart failure OR normal blood potassium currently but previously had high potassium in the12 months prior to screening which caused a permanent reduction or discontinuation of heart failure medications

• Hospitalization for heart failure or treatment in an out patient setting with intravenous medications within the last 12 months before screening.

Exclusion Criteria:

• Current acute decompensated HF, within 4 weeks before screening. Subjects with a discharge from a hospitalization for acute decompensation of HF longer than 4 weeks before screening may be included

• Significant primary aortic or mitral valvular heart disease (except secondary mitral regurgitation due to left ventricular dilatation)

• Heart transplantation or planned heart transplantation (i.e., currently on a heart transplant waiting list) during the study period