Evaluation of Patiromer in Heart Failure Patients
Condition: Hyperkalemia; Heart Failure
MeSH terms: Heart Failure; Hyperkalemia
Intervention: patiromer; placebo
Intervention description: Active investigational drug; placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HF; Heart failure; hyperkalemia; chronic kidney disease; prevention of hyperkalemia in heart failure participants

Summary:

      The purpose of this study was to assess the effects of patiromer on serum potassium
      participants with heart failure. This study also assessed the safety and tolerability of
      patiromer in participants with heart failure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with chronic heart failure clinically indicated to receive spironolactone
             therapy, aged 18 years or older with serum potassium level of 4.3 - 5.1 mEq/L at
             screening and baseline, AND (1) chronic kidney disease (GFR < 60 mL/min) OR (2)
             documented history of hyperkalemia within the last 6 months

          -  Females of child-bearing potential must be non-lactating, must have a negative serum
             pregnancy test at screening, and must have used a highly effective form of
             contraception for at least 3 months before study drug administration, during the
             study, and for one month after study completion

          -  Male participants and/or their female partners of child-bearing potential must use a
             highly effective form of contraception during the study and for 3 months after study
             completion

          -  Must sign informed consent document

        Exclusion Criteria:

          -  History of bowel obstruction, swallowing disorders, severe gastrointestinal disorders
             or major gastrointestinal surgery

          -  Uncorrected hemodynamically significant primary valvular disease, known obstructive or
             restrictive cardiomyopathy, uncontrolled or hemodynamically unstable arrhythmia

          -  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

          -  Heart transplant recipient, or anticipated need for transplant during study
             participation

          -  Any of the following events having occurred within 3 months prior to baseline:
             unstable angina as judged by the Investigator, unresolved acute coronary syndrome,
             transient ischemic attack or stroke

          -  Current dialysis participant, or anticipated need for dialysis during study
             participation

          -  Prior kidney transplant, or anticipated need for transplant during study participation

          -  Metastatic, late-stage or end-stage cancer with < 12 months life expectancy

          -  History of alcoholism or drug/chemical abuse within 1 year

          -  QTcB interval > 500 msec (Bazett's correction formula)

          -  Sustained systolic blood pressure > 170 or < 90 mmHg

          -  Liver enzymes (ALT, AST) > 3 times upper limit of normal

          -  Use of oral cardiac medications (including loop and thiazide diuretics) that have not
             been stable for at least 21 days prior to baseline and are not anticipated to remain
             stable during study participation

          -  Use of any IV cardiac medications within 21 days prior to baseline, or their
             anticipated need during study participation.

          -  Current use of polymer-based drugs (e.g. Renagel, Kayexalate, Welchol, Colestid),
             other phosphate binders or potassium binders, calcium supplements, antacids (eg TUMS,
             Maalox), or their anticipated need during study participation

          -  Use of aldosterone antagonist in the last 30 days prior to baseline, unless was
             discontinued due to hyperkalemia

          -  Use of potassium sparing medication and/or potassium supplements in the last 30 days
             prior to baseline

          -  Use of any investigational medication, 30 days or 5 half-lives whichever is longer,
             prior to baseline

          -  Participants who have taken investigational product in this study, or a previous
             patiromer study

          -  Inability to consume the study medication, or, in the opinion of the Investigator,
             inability to comply with the protocol

          -  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