Patiromer for the Management of Hyperkalemia in Subjects Receiving RAASi Medications for the Treatment of Heart Failure (DIAMOND)
Condition: Hyperkalemia
MeSH terms: Heart Failure; Hyperkalemia
Intervention: Patiromer; Placebos
Intervention description: The starting dose of patiromer will be 1 packet/day and may be taken either with food or without food. Based upon the patiromer treatment algorithm patiromer may be increased by 1 packet per day in intervals of at least 1 week (± 3 days). For subjects who become hypokalemic, patiromer may be decreased to a minimum of 0 packets/day. Doses of patiromer will be 0 packets/day, 1 packet/day, 2 packets/day, and 3 packets/day (maximum dose).; The starting dose of placebo will be 1 packet/day and may be taken either with food or without food. Based upon the placebo treatment algorithm placebo may be increased by 1 packet per day in intervals of at least 1 week (± 3 days). For subjects who become hypokalemic, placebo may be decreased to a minimum of 0 packets/day. Doses of placebo will be 0 packets/day, 1 packet/day, 2 packets/day, and 3 packets/day (maximum dose).
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective Phase 3b multinational, multicenter, double-blind, placebo-controlled, randomized withdrawal, parallel group study that includes screening and 12 weeks Run-in Phase and a randomized withdrawal Blinded Treatment Phase.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1195.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: treatment of hyperkalemia; chronic kidney disease; hypertension; hyperkalemia; potassium; spironolactone; heart failure; Renin Angiotensin-Aldosterone System Inhibitor (RAASi); RAASi; high potassium; eplerenone; reduced ejection fraction

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

Eligibility 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