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oai:repisalud.isciii.es:20.500.12105/199192024-09-27T08:00:47Zcom_20.500.12105_19604com_20.500.12105_2051col_20.500.12105_19605

00925njm 22002777a 4500 dc Pascual-Figal, Domingo A author Núñez Villota, Julio author Pérez-Martínez, Maria Teresa author González-Juanatey, José Ramón author Taibo-Urquía, Mikel author Llàcer Iborra, Pau author González-Martín, Javier author Villar, Sandra author Soler, Meritxel author Mirabet, Sonia author Aimo, Alberto author Riquelme-Pérez, Alejandro author Anguita Sánchez, Manuel author Martínez-Sellés, Manuel author Sánchez, Pedro L author Ibáñez, Borja author Bayés-Genís, Antoni author 2024-06-04 AIMS Heart failure (HF) elicits a pro-inflammatory state, which is associated with impaired clinical outcomes, but no anti-inflammatory therapies have demonstrated a clinical benefit yet. Inflammatory pathways related with the interleukin-1 axis are overactivated during episodes of acute HF. Colchicine, an anti-inflammatory drug with proven benefits in acute pericarditis and ischaemic heart disease, may target this inflammatory response. This study aims to assess the efficacy of colchicine in acute HF patients. METHODS COLICA is a multicentre, randomized, double-blind, placebo-controlled trial enrolling 278 patients across 12 sites. Patients presenting with acute HF, clinical evidence of congestion requiring ≥40 mg of intravenous furosemide and N-terminal pro-B-type natriuretic peptide (NT-proBNP) >900 pg/ml, are eligible for participation. Patients are enrolled irrespective of left ventricular ejection fraction, HF type (new-onset or not) and setting (hospital or outpatient clinic). Patients are randomized 1:1 within the first 24 h of presentation to either placebo or colchicine, with an initial loading dose of 2 mg followed by 0.5 mg every 12 h for 8 weeks (reduced dose if <70 kg, >75 years old, or glomerular filtration rate <50 ml/min/1.73 m2). The primary efficacy endpoint is the time-averaged proportional change in NT-proBNP concentrations from baseline to week 8. Key secondary and exploratory outcomes include symptoms, diuretic use, worsening HF episodes, related biomarkers of cardiac stress and inflammation, total and cardiovascular readmissions, mortality and safety events. CONCLUSION COLICA will be the first randomized trial testing the efficacy and safety of colchicine for acute HF. Eur J Heart Fail. 2024 Jun 4. http://hdl.handle.net/20.500.12105/19919 38837516 10.1002/ejhf.3300 1879-0844 European journal of heart failure Colchicine in acute heart failure: Rationale and design of a randomized double-blind placebo-controlled trial (COLICA).