Colchicine in Acutely Decompensated Heart Failure With Reduced Ejection Fraction: a Pilot Study

What this Trial Is About

This research evaluates colchicine, an anti-inflammatory drug, in patients hospitalized with acutely decompensated heart failure with reduced ejection fraction (HFrEF) who also show signs of inflammation. The study aims to compare colchicine with placebo to see if it reduces inflammation markers, such as high sensitivity C-reactive protein (hsCRP) and interleukin-6 (IL-6), during the vulnerable period following heart failure exacerbation. This pilot trial is randomized, double-blind, and placebo-controlled, designed to explore colchicine's role alongside standard heart failure care, which includes medications to relieve symptoms and support heart function. Participants will be randomly assigned to receive either colchicine or a matching placebo. The colchicine group will take 0.6 mg twice daily for 14 days, followed by 0.6 mg once daily for about 76 days; dose adjustments are made for patients with chronic kidney disease or gastrointestinal symptoms. The placebo group follows the same schedule with inactive pills. Treatment will add to usual heart failure care without withholding any standard medications. The study includes a 90-day treatment period to cover the vulnerable phase when patients are at higher risk of further heart failure events. During the study, blood samples will be collected at baseline, 24, 48, and 72 hours after treatment start while still hospitalized, plus at 14 days during an outpatient visit and at the study conclusion around 90 days. Researchers will monitor inflammation markers and assess clinical status, medication compliance, and safety throughout. The primary outcome is the change in hsCRP within the first 72 hours, with secondary outcomes including longer-term hsCRP and IL-6 changes. Participants will be followed closely to understand colchicine's impact on inflammation in this high-risk period.

Colchicine in Acutely Decompensated HFREF