IC14 for Treatment of Acute Decompensated Heart Failure

Korábbi kezelés

• 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.
• Recent (previous 3 months) or planned cardiac resynchronization therapy (CRT) or valve surgeries.
• Previous or planned implantation of left ventricular assist devices or heart transplant.
• 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).
• Hypersensitivity to IC14 or previous adverse reaction to antibody-based treatments.

Más betegség

• The primary diagnosis for admission is NOT decompensated heart failure, including diagnosis of acute coronary syndromes, hypertensive urgency/emergency, tachy- or brady-arrhythmias.
• Chronic inflammatory disorder (i.e., rheumatoid arthritis, systemic lupus erythematosus).
• 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.
• Active malignancy - excluding carcinoma in situ [any location] or localized non-melanoma skin cancer.
• Any comorbidity limiting survival or ability to complete the study, including end-stage heart failure.
• Stage V kidney disease or on renal-replacement therapy or renal transplant recipient.

Egyéb

• Current or planned use of intravenous inotropes.
• Neutropenia (<1,500/mm3 or <1,000/mm3 in Black/African-American patients).
• Pregnancy.

• Patients may be included in the study only if they meet all of the following criteria:
• Primary diagnosis for hospitalization is decompensated heart failure established as the finding at admission of both conditions listed below:
  • dyspnea or respiratory distress or tachypnea at rest or with minimal exertion; and
  • 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.
• 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).
• 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.
• The patient has recently received (past 24 hours) or is scheduled to received intravenous loop diuretics.
• 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).
• The patient has screening plasma C-reactive protein levels >3 mg/L (0.3 mg/dL).
• Males and females of childbearing potential must use effective contraception.