Randomized Double-blind Trial to Study the Benefit of Colchicine in Patients With Acutely Decompensated Heart Failure

The primary objective of the study is the reduction of NT-proBNP at two months of treatment. A secondary objective is to attain a greater clinical stability, in terms of reduction of new HF decompensations and need for diuretics, and symptoms improvement. The calculated population size is 278 patients. Follow-up visits will be carried out at discharge, 7 days, 4 weeks and 8 weeks after the hospital discharge. The potential of the study is very high given the high prevalence and clinical impact of HF hospitalizations, together with the absence of specific treatment for this phase of the disease. Therefore, in case of a positive result, this would mean a huge clinical, social and health benefits, as well as being an important therapeutic progress.

Inclusion criteria

• Unscheduled visit for symptoms and / or congestive signs of HF that require treatment with intravenous diuretics (at least 40 mg intravenous furosemide)
• Clinical evidence, by symptoms or signs, and / or radiological of congestion.
• NT-proBNP concentration greater than 900 pg / ml at screening visit.
• Age over 18 years.
• Patients who have given their informed consent in writing.

Exclusion criteria

• Severe valve disease with indication for surgical repair.
• Extracardiac disease with estimated vital prognosis of less than 1 year.
• Inflammatory bowel disease (Crohn's disease or ulcerative colitis), diarrhea chronic or malabsorption.
• Rheumatic inflammatory disease.
• Serious gastrointestinal disorders
• Stomach ulcer
• Hematological disorders, such as blood dyscrasias
• Previous neuromuscular disease
• Severe renal failure (glomerular filtration rate <30 ml / kg / min / 1.73m2)
• History of cirrhosis, chronic active hepatitis or severe liver disease, defined by GOT (AST) or GPT (ALT) values that exceed 3 x upper limit of normality
• Patient who is taking colchicine for other indications (mainly chronic prescriptions for familial Mediterranean fever or gout). No washout period will be required for patients who have been treated with colchicine and have stopped treatment prior to randomization.
• Patient with a history of allergic reactions or significant sensitivity to colchicine.
• Chronic treatment with immunosuppressants, corticosteroids, interleukin-1 antagonists in the 6 months prior to inclusion.
• Pregnant or lactating women, where pregnancy is defined as the state of a woman after conception and until the end of gestation, confirmed by a positive test result for human chorionic gonadotropin (hCG), or planned become pregnant or plan to breastfeed during study treatment or within 30 days of the end of study drug treatment.
• Woman of childbearing potential who is unwilling to inform her partner of her participation in this clinical study or to use 2 effective contraceptive methods that are acceptable or to practice strict sexual abstinence (the investigator must assess the reliability of sexual abstinence and make it the preferred and usual lifestyle of the subject) during treatment with study drug (colchicine or placebo) and for an additional 30 days after the last dose of study drug.