Colchicine in Patients with Heart Failure with Preserved Ejection Fraction and Inflammation

Launched by DONGYING ZHANG · Sep 17, 2024

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ClinConnect Summary

The CHIPS trial is studying whether a medication called colchicine can help patients with heart failure who have preserved ejection fraction (HFpEF) and are experiencing inflammation. The aim is to see how colchicine affects inflammation levels, heart structure and function, symptoms, and exercise ability in these patients. The trial is looking for participants between the ages of 65 and 74 who have specific heart conditions, such as certain measurements from heart tests (like echocardiograms) that show changes in heart structure and function, as well as elevated levels of a hormone called NT-proBNP.

To be eligible for this trial, patients must have evidence of heart issues and must have had a worsening of their heart failure symptoms recently. However, individuals with certain conditions like recent heart surgery, severe kidney or liver problems, or who are pregnant or breastfeeding cannot participate. Those who join the trial will be monitored closely to understand how well colchicine works and to ensure their safety throughout the study. If you or a loved one think you might qualify, please consult your healthcare provider for more information.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • Left ventricular ejection fraction measured by echocardiography ≥ 50%
• • Objective evidence of structural of functional abnormalities measured by echocardiography: 1)LVMI≥95 g/m2 in female and ≥115 g/m2 in male or 2)LAVI greater than 29ml/m2 in sinus rhythm or greater than 40ml/m2 in atrial fibrillation or 3)Average E/e' greater than 14 or 4)TR velocity greater than 2.8 m/s
• • Patients with elevated NT-proBNP levels 24 hours after discontinuing intravenous diuretics: ≥300 pg/ml in patients with sinus heart rate; ≥600 pg/ml in patients with atrial fibrillation
• • Both outpatient and admitted patients can be considered for enrollment. All patients must occurred worsening heart failure event within 30 days prior to randomization and a current NYHA cardiac function class II-IV
• • Patients with CRP levels greater than 2mg/L
• • Patient agrees to join and signs a written informed consent form
• Exclusion Criteria:
• • Received colchicine treatment within one month prior to randomization
• • Acute coronary syndrome within 3 months prior to randomization, or history of pacemaker implantation, PCI, CABG within 3 months
• • eGFR less than 25 mL/min/1.73 m2
• • Liver function Child-Pugh class B or C
• • Patient has a history of previous allergy to colchicine or dapagliflozin / empagliflozin
• • Heart failure due to the following reasons: pericardial disease, pericardial effusion, myocarditis, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, and other rare cardiomyopathies such as Fabry disease
• • Combined diagnosis of gastric ulcer, ulcerative colitis, Crohn disease and other digestive disorders or combined gastrointestinal tumors
• • Plan to undergo cardiac surgery such as coronary revascularization, radiofrequency ablation of arrhythmias, valve replacement or other surgical procedures
• • Pregnant or breastfeeding women
• • The patient who is cognitively impaired and is unable to accurately complete the assessment and completion of the KCCQ scale with the assistance of a physician
• • Autoimmune diseases such as systemic lupus erythematosus, long-term adrenocorticotropic hormone treatment for other diseases such as Schihan syndrome, or need to accept immunosuppressive drugs and monoclonal antibodies such as IL-1 and IL-6
• • Patient with combined active solid tumor or hematological malignancy
• • Patient comorbidity with other conditions that may be confused with HFpEF symptoms, such as acute exacerbation of COPD
• • Admission with a well-defined infection (symptoms or pathogenetic evidence of infection, and leukocytes greater than 10\*109/L)
• • Previously diagnosed with HFrEF (initial assessment of LVEF less than 40%) or diagnosed with LVimpEF