This is a placebo-controlled study to determine the effect of CLP in heart failure subjects with fluid overload.
Elegibilidad
Edad mínima: 21 YearsSexo: ALL
Criterios de inclusión
Ambulatory and able to perform the 6-minute walk test
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
Criterios de exclusión
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
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A Phase 2b, Randomized, Double-Blind, Multi-center Study ... | EligiMed