Anti-Inflammatory Treatment of Uremic Cardiomyopathy With Colchicine

Exclusion Criteria24

• History of intolerance or allergy to colchicine
• Hospitalization for any reason within the previous 30 days
• Acute condition that requires emergent treatment in the opinion of a physician investigator
• Stage C or D heart failure according to ACC-AHA criteria77
• Left ventricular ejection fraction less than 40%
• Symptomatic valvular heart disease
• Congenital heart disease (corrected or uncorrected)
• History of orthotopic heart transplant
• Kidney failure, defined as kidney transplant recipient or requirement for hemodialysis or peritoneal dialysis
• Worsening kidney function or acute kidney injury, defined as an increase in serum creatinine of greater than 0.3 mg/dL in the previous 30 days or 50% within the previous 7 days
• Use of immunosuppressive or anti-inflammatory medications within the previous 30 days, with the exception of less than 5 days of non-steroidal anti-inflammatory drugs or corticosteroids for acute pain or other acute conditions that have since fully resolved provided that the last dose of non-steroid anti-inflammatory drug was at least 7 days before enrollment
• Familial Mediterranean Fever, gout (unless no flare within the previous 12 months), pericarditis or other indications for colchicine treatment
• Use of systemic antimicrobial therapy within the previous 30 days or active infection
• History of respiratory illness that, in the opinion of a physician investigator, may increase the risk of pneumonia
• Surgery within the previous 30 days or surgery planned to occur within the expected study period
• Current malignancy or receipt of treatment for malignancy within the previous 1 year
• Frailty or life-expectancy shortened by comorbidity such as cancer that would increase the participant's risk in the opinion of a physician investigator
• Neutrophil count \< 2,000 cells/mm3
• Platelet count \< 50,000 cells/mm3
• Concomitant use of a P-gp inhibitor (e.g., cyclosporine, ranolazine, digoxin) and/or moderate-strong CYP3A4 inhibitor (e.g., clarithromycin, indinavir, itraconazole, ritonavir, nefazodone, diltiazem, verapamil, grapefruit juice, fluconazole)
• Medications that may cause myopathy or rhabdomyolysis (i.e., simvastatin, gemfibrozil, fenofibrate) , a creatine kinase level after the run-in period that exceeds the upper limit of the normal laboratory reference range (if baseline was below the upper limit) or that increases by 50% or more from pre- to post-run-in
• Moderate-severe hepatic disease (Child-Pugh B or C)
• Pregnant or unwilling/unable to assure appropriate contraception
• Breastfeeding