Interleukin-1 Blockade in Recently Decompensated Heart Failure (RED-HART)
Heart Failure
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
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.
Sites / Locations
- Virginia Commonwealth University
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
Anakinra (short)
Anakinra (long)
Placebo
Anakinra 100 mg daily for 2 weeks, followed by placebo for 10 weeks
Anakinra 100 mg daily for 12 weeks
Placebo injections daily for 12 weeks