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

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