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dc.contributor.author | Pascual-Figal, Domingo A | |
dc.contributor.author | Núñez Villota, Julio | |
dc.contributor.author | Pérez-Martínez, Maria Teresa | |
dc.contributor.author | González-Juanatey, José Ramón | |
dc.contributor.author | Taibo-Urquía, Mikel | |
dc.contributor.author | Llàcer Iborra, Pau | |
dc.contributor.author | González-Martín, Javier | |
dc.contributor.author | Villar, Sandra | |
dc.contributor.author | Soler, Meritxel | |
dc.contributor.author | Mirabet, Sonia | |
dc.contributor.author | Aimo, Alberto | |
dc.contributor.author | Riquelme-Pérez, Alejandro | |
dc.contributor.author | Anguita Sánchez, Manuel | |
dc.contributor.author | Martínez-Sellés, Manuel | |
dc.contributor.author | Sánchez, Pedro L | |
dc.contributor.author | Ibáñez, Borja | |
dc.contributor.author | Bayés-Genís, Antoni | |
dc.date.accessioned | 2024-07-02T14:59:27Z | |
dc.date.available | 2024-07-02T14:59:27Z | |
dc.date.issued | 2024-06-04 | |
dc.identifier.citation | Eur J Heart Fail. 2024 Jun 4. | es_ES |
dc.identifier.uri | http://hdl.handle.net/20.500.12105/19919 | |
dc.description.abstract | 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. | es_ES |
dc.description.sponsorship | COLICA trial has been funded by ‘Instituto de Salud Carlos III’ (ISCIII) through the project ICI19/00055 and co-funded by the European Union (FEDER). The CNIC is supported by the ISCIII, the Ministerio de Ciencia, Innovación y Universidades (MICIU) and the Pro CNIC Foundation, and is a Severo Ochoa Center for Excellence (Grant CEX2020-001041-S funded by MICIU/AEI/10.13039/501100011033). Conflict of interest: D.P.F. has received consultancy and speaker fees and lectures from AstraZeneca, Novartis, Roche Diagnostics, Pfizer, Vifor, Rovi, Bayer. J.N.V. has received consultancy and speaker fees and lectures from AstraZeneca, Alleviant, Amgen, Bayer, Boehringer Ingelheim, CSL Vifor, Daiichi Sankyo, GSK, Lilly, Pfizer, Novartis, NovoNordisk, and Rovi. A.B.G. has participated in advisory boards and/or lectured for Abbott, AstraZeneca, Bayer, Boehringer Ingelheim, Novartis, Roche Diagnostics, Vifor. All other authors have nothing to disclose. | es_ES |
dc.language.iso | eng | es_ES |
dc.publisher | Wiley | es_ES |
dc.type.hasVersion | VoR | es_ES |
dc.rights.uri | http://creativecommons.org/licenses/by-nc-nd/4.0/ | * |
dc.title | Colchicine in acute heart failure: Rationale and design of a randomized double-blind placebo-controlled trial (COLICA). | es_ES |
dc.type | journal article | es_ES |
dc.rights.license | Attribution-NonCommercial-NoDerivatives 4.0 Internacional | * |
dc.identifier.pubmedID | 38837516 | es_ES |
dc.identifier.doi | 10.1002/ejhf.3300 | es_ES |
dc.contributor.funder | Instituto de Salud Carlos III | es_ES |
dc.contributor.funder | Unión Europea. Fondo Europeo de Desarrollo Regional (FEDER/ERDF) | es_ES |
dc.contributor.funder | Ministerio de Ciencia, Innovación y Universidades (España) | es_ES |
dc.contributor.funder | Fundación ProCNIC | es_ES |
dc.contributor.funder | Ministerio de Ciencia e Innovación. Centro de Excelencia Severo Ochoa (España) | es_ES |
dc.description.peerreviewed | Sí | es_ES |
dc.identifier.e-issn | 1879-0844 | es_ES |
dc.relation.publisherversion | 10.1002/ejhf.3300 | es_ES |
dc.identifier.journal | European journal of heart failure | es_ES |
dc.repisalud.orgCNIC | CNIC::Grupos de investigación::Laboratorio Traslacional para la Imagen y Terapia Cardiovascular | es_ES |
dc.repisalud.institucion | CNIC | es_ES |
dc.rights.accessRights | open access | es_ES |
dc.relation.projectFECYT | info:eu-repo/grantAgreement/ES/MICIU/AEI/10.13039/501100011033/CEX2020-001041-S | es_ES |