Heart Failure
Conditions
Brief summary
This is a placebo-controlled study to determine the effect of CLP in heart failure subjects with fluid overload.
Interventions
DRUGCLP
DRUGplacebo
Sponsors
Sorbent Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline, Week 8 | 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. |
Secondary
| Measure | 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 |
Countries
Argentina, Israel, United States
Contacts
Primary ContactJade Brennan
Backup ContactJean Chang
Outcome results
None listed