Colchicine in Acutely Decompensated HFREF

Prior treatment

• 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
• Previous or planned implantation of left ventricular assist devices or heart transplantation
• Current or recent (i.e. within 4 half-lives) use of immunosuppressive or anti-inflammatory drugs (not including NSAIDs).
• Current treatment with colchicine or planned initiation of colchicine therapy in the next three months for gout
• Prior (within the past 5 years) or current malignancy, with the exclusion of in situ lesion with low potential for progression
• Treatment with medication contraindicated for concomitant use with colchicine per
  • Food and Drugs Administration labeling, including:
• Protease inhibitors

Other illness

• Cardiac resynchronization therapy (CRT), coronary artery revascularization procedures, or heart valve surgeries performed within 3 months or planned during the admission
• Chronic inflammatory disorder, including but not limited to rheumatoid arthritis and systemic lupus erythematosus
• Active infection (of any type)
• Chronic or recurrent infectious disease, including hepatitis B virus, hepatitis C virus, and HIV/AIDS
• End-stage kidney disease requiring renal replacement therapy

Lab values

• Presence of specific contraindications to colchicine treatment, which may include
  • Previous adverse reaction to colchicine
  • Biliary obstruction
  • Renal impairment with estimated glomerular filtration rate (eGFR) \<30 ml/min
  • Liver cirrhosis from stage Child-Pugh A to more advanced
• Non-dihydropiridine calcium channel blockers

Other

• Chronic use of intravenous inotropes
• Any comorbidity leading to expected survival less than three months or inability to complete the study
• Neutropenia (\<2,000/mm3) or Thrombocytopenia (\<50,000/mm3)
• Pregnancy
  • For all biological females with child bearing potential a pregnancy test will be performed as part of standard of care.
• Prisoners
• Macrolides antibiotic
• Ketoconazole, Fluconazole and Itraconazole
• Nefazodone
• Aprepitant
• Ranolazine
• Cyclosporine

• Primary admission diagnosis of acute decompensated heart failure as evidenced by:
  • Heart failure symptoms and at least one of the following:
  • Pulmonary congestion/edema at physical exam (or chest radiography)
  • E/e' \> 13 on transthoracic echocardiography
  • Left heart catheterization showing elevated left ventricular (LV) end-diastolic pressure \>18 mmHg or right heart catheterization showing pulmonary artery occluding pressure (wedge) \>16 mmHg
  • Elevated plasma B-type natriuretic peptide (\>100 pg/ml) or N-terminal B-type natriuretic peptide (\>300 pg/ml)
• LV systolic dysfunction (left ventricular ejection fraction \[LVEF\] \<40%) during the index hospitalization or prior 12 months;
• Expected duration of heart failure at least three months
• Age 18 years or older
• Willing and able to provide written informed consent
• Screening plasma CRP \>0.3 mg/dL (3 mg/L) or high-sensitivity CRP \>2 mg/L