Evaluation of Cross-Linked Polyelectrolyte (CLP) With Placebo in Heart Failure Subjects (STEPWISE)

Selected Inclusion Criteria:

• Age 21 years or older at randomization

• Heart failure with at least one of the following signs of current fluid overload:

  1. Peripheral (or sacral) edema >1+ or ascites during screening or on day of randomization
  2. Pulmonary congestion as determined by chest X-ray during the screening period
• Ambulatory and able to perform the 6-minute walk test

Selected Exclusion Criteria:

• Participation in another clinical trial of an investigational or marketed drug within 30 days or 5 half-lives (whichever is longer) preceding screening
• Any hospitalization or unscheduled outpatient decongestion therapy using IV diuretics, ultrafiltration, or paracentesis within 8 weeks prior to or during screening
• Coronary-artery bypass graft, percutaneous intervention (e.g., cardiac, cerebrovascular, aortic), or major surgery including thoracic and cardiac, within 2 months prior to or during screening or anticipated need during study participation
• Heart transplant recipient, or anticipated need for transplant or LVAD during study participation
• Any of the following events having occurred within 8 weeks prior to or during screening: myocardial infarction, transient ischemic attack, stroke, or acute coronary syndrome as judged by the Investigator