IC14 for Treatment of Acute Decompensated Heart Failure

Eligibility Criteria

• 1. Primary diagnosis for hospitalization is decompensated heart failure established as the finding at admission of both conditions listed below:
• 1. dyspnea or respiratory distress or tachypnea at rest or with minimal exertion; and
• 2. evidence of elevated cardiac filling pressure or pulmonary congestion (at least one of the conditions must be met):
• * Pulmonary congestion/edema a physical exam OR chest x-ray;
• * plasma BNP levels ≥200 pg/ml or N-terminal-proBNP ≥600 pg/ml; or
• * invasive measurement of left ventricular end-diastolic pressure (LVEDP) \>18 mmHg or of pulmonary artery occluding pressure (wedge pressure) \>16 mmHg.
• 2. The patient has a prior documentation of impaired left ventricular systolic function (left ventricular ejection fraction \<40%) at most recent assessment by any imaging modality (within 12 months).
• 3. The patient is symptomatic for moderate to severe dyspnea at time of enrollment as indicated by a score on the visual analog scale for dyspnea of 40 or more (in a scale of 1 to 100, where 0 is no shortness of breath and 100 is extremely short of breath) in the prior 12 hours.
• 4. The patient has recently received (past 24 hours) or is scheduled to received intravenous loop diuretics.
• 5. The patient is of age ≥21 years old, willing and able to provide written informed consent and to comply with the protocol (i.e., reporting of symptoms).
• 6. The patient has screening plasma C-reactive protein levels \>3 mg/L (0.3 mg/dL).
• 7. Males and females of childbearing potential must use effective contraception.
• 1. The primary diagnosis for admission is NOT decompensated heart failure, including diagnosis of acute coronary syndromes, hypertensive urgency/emergency, tachy- or brady-arrhythmias.
• 2. Concomitant clinically significant comorbidities that would interfere with the execution or interpretation of the study including but not limited to acute coronary syndromes; uncontrolled hypertension or orthostatic hypotension; tachy- or brady-arrhythmias; acute or chronic pulmonary disease; or neuromuscular disorders affecting respiration.
• 3. Recent (previous 3 months) or planned cardiac resynchronization therapy (CRT) or valve surgeries.
• 4. Previous or planned implantation of left ventricular assist devices or heart transplant.
• 5. Current or planned use of intravenous inotropes.
• 6. Recent (\<14 days) use of immunosuppressive or anti-inflammatory drugs (including oral corticosteroids at a prednisone equivalent dose of ≥0.5 mg/kg/day but not including inhaled or low-dose oral corticosteroids, non-steroidal anti-inflammatory drugs or colchicine).
• 7. Chronic inflammatory disorder (i.e., rheumatoid arthritis, systemic lupus erythematosus).
• 8. Active infection (of any type), including chronic/recurrent infectious disease (including hepatitis B virus, hepatitis C virus, and HIV/AIDS) - but excluding HCV+ with undetectable plasma RNA.
• 9. Active malignancy - excluding carcinoma in situ \[any location\] or localized non-melanoma skin cancer.
• 10. Any comorbidity limiting survival or ability to complete the study, including end-stage heart failure.
• 11. Stage V kidney disease or on renal-replacement therapy or renal transplant recipient.
• 12. Neutropenia (\<1,500/mm3 or \<1,000/mm3 in Black/African-American patients).
• 13. Pregnancy.
• 14. Hypersensitivity to IC14 or previous adverse reaction to antibody-based treatments.