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

Study Overview
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Brief Summary
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This is a placebo-controlled study to determine the effect of CLP in heart failure subjects with fluid overload.

Official Title
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A Phase 2b, Randomized, Double-Blind, Multi-center Study Comparing Cross-linked Polyelectrolyte (CLP) With Placebo in Heart Failure Subjects

Conditions
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Heart Failure

Intervention / Treatment
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* Drug: CLP
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Selected Inclusion Criteria: Age 21 years or older at randomization Heart failure with at least one of the following signs of current fluid overload: Peripheral (or sacral) edema >1+ or ascites during screening or on day of randomization 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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CLP<br>CLP BID | Drug: CLP<br> <br> |
| Placebo Comparator: Placebo<br>BID powder | Drug: placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite endpoint comprised of: 6-Minute Walk Test, Body weight, KCCQ Score, Log2 NT-proBNP, time to first occurrence of heart/renal failure hospitalization, unscheduled outpatient intravenous or mechanical therapy for heart/renal failure or death | Composite endpoint for the change from baseline to 8 weeks comprised of the following: 6-Minute Walk Test (6 MWT), Body weight, KCCQ Score, Log2 NT-proBNP, time to first occurrence of heart failure or renal failure hospitalization, unscheduled outpatient intravenous or mechanical therapy for heart failure or renal failure, or death. | Baseline, Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 6-Minute Walk Test distance from baseline to Week 8. |  | Baseline, Week 8 | 
| Time to heart failure or renal failure hospitalization, unscheduled outpatient intravenous or mechanical therapy for heart failure or renal failure, or death |  | 8 weeks |