Interleukin-1 Blockade in Recently Decompensated Heart Failure

Inclusion criteria

All 6 criteria need to be met for enrollment of the patient in the study

• Primary diagnosis for hospitalization is decompensated heart failure established as the finding at admission of all 2 conditions listed below:

• dyspnea or respiratory distress or tachypnea at rest or with minimal exertion;
• evidence of elevated cardiac filling pressure or pulmonary congestion (at least one of the conditions must be met);

• pulmonary congestion/edema at physical exam OR chest X-Ray;
• plasma Brain Natriuretic Peptide (BNP) levels ≥200 pg/ml;
• invasive measurement of left ventricular end-diastolic pressure >18 mmHg or of pulmonary artery occluding pressure (wedge) >16 mmHg.
• The patient has a prior documentation of impaired left ventricular systolic function (ejection fraction <50%) at most recent assessment by any imaging modality (within 12 months).
• The patient is now clinically stable and meets standard criteria for hospital discharge as documented by all the 3 conditions listed below:

• absence of dyspnea or pulmonary congestion/distress at rest;
• absence of pitting edema in the lower extremities, or in any other region;
• stable hemodynamic parameters (blood pressure, heart rate).
• The patient is of age ≥21 years old, and is willing and able to provide written informed consent.
• The patient is willing and able to comply with the protocol (i.e. self administration of the treatment, and exercise protocol).
• The patient has screening plasma C-reactive protein levels >2 mg/L.

Exclusion criteria

Subjects will not be eligible if they meet any of the following 15 exclusion criteria.

• The primary diagnosis for admission is NOT decompensated heart failure, including diagnosis of acute coronary syndromes, hypertensive urgency/emergency, tachy- or brady-arrhythmias.
• 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), coronary artery revascularization procedures, or heart valve surgeries.
• Previous or planned implantation of left ventricular assist devices or heart-transplant.
• Chronic use of intravenous inotropes.
• Recent (<14 days) use of immunosuppressive or anti-inflammatory drugs (not including Non-Steroidal Anti-Inflammatory Drugs [NSAIDs]).
• Chronic inflammatory disorder (including but not limited to rheumatoid arthritis, systemic lupus erythematosus).
• Active infection (of any type);
• Chronic/recurrent infectious disease (including Hepatitis B virus [HBV], Hepatitis C virus [HCV], and HIV/AIDS).
• Prior (within the past 10 years) or current malignancy.
• Any comorbidity limiting survival or ability to complete the study.
• End stage kidney disease requiring renal replacement therapy.
• Neutropenia (<2,000/mm3) or Thrombocytopenia (<50,000/mm3).
• Pregnancy.
• Angina, arrhythmias, or electrocardiograph (ECG) changes that limit maximum exertion during cardiopulmonary exercise testing obtained during the baseline testing.