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This is a placebo-controlled study to determine the effect of CLP in heart failure subjects with fluid overload.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CLP | Experimental | CLP BID |
|
| Placebo | Placebo Comparator | BID powder |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CLP | Drug |
| ||
| placebo | Drug |
| 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 |
| 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 |
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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:
Ambulatory and able to perform the 6-minute walk test
Selected Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jade Brennan | Contact | 919-491-5721 | jadebrennan@momentum-research.com | |
| Jean Chang | Contact | jchang@sorbent.com |
| Name | Affiliation | Role |
|---|---|---|
| Howard Dittrich, MD | Sorbent Therapeutics, Study Sponsor | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orange Country Research Center | Recruiting | Tustin | California | 92780 | United States |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
| Recruiting | Buenos Aires | Argentina |
| Recruiting | Ashkelon | Israel |