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NCT04705987CompletedPhase 3

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

Source: ClinicalTrials.gov · Last updated 22 May 2024

Brief summary (registry, in English)

Heart failure (HF) is a chronic disease associated with multiple acute decompensations, which are the main cause of hospital admission above 65 years and two thirds of the high costs associated with the disease. Furthermore, in the patient they reflect a phase of clinical instability, with a higher risk of early readmission (20-30% at 30 days) and higher mortality (10-15% at 30 days and 30-40% at 1year). However, the investigators do not have treatments specifically aimed at this unstable phase, known as acute or decompensated (HF). It is known that, in this acute and unstable state, there is an increase in inflammatory parameters. Indeed, our group has recently demonstrated the relevance of the interleukin-1 axis, in particular IL-1beta and sST2 concentrations identified a worse prognosis regardless of HF phenotype. Colchicine, a widely available drug, has proven to be a powerful cardiovascular anti-inflammatory, acting on inflammasome and therefore inhibiting the production of IL1-beta.The study hypothesis is that colchicine administered early during the acute phase can promote stability in terms of biomarkers of cardiac function and new decompensations. For this it is designed a randomized, double-blind clinical study with two arms (colchicine 0.5 mg vs. placebo) initiated within the first 24 hours of hospitalisation and administered for 60 days, in patients with acute decompensated HF with either reduced or preserved LV ejection fraction.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
279 (actual)
First submitted
11 Jan 2021
Start date
8 Feb 2021
Primary completion date
17 May 2024
Lead sponsor
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
NCT number
NCT04705987
EU CT number
2023-504165-23-00
EudraCT number
2020-000941-15

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 279
  • From 8 Feb 2021 to the primary completion date, 17 May 2024
  • 12 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous neuromuscular disease
  • 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.
  • 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.

Other illness

  • 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
  • Severe renal failure (glomerular filtration rate \<30 ml / kg / min / 1.73m2)
  • Patient with a history of allergic reactions or significant sensitivity to colchicine.

Lab values

  • 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

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (12)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital Universitari Germans Trias i Pujol
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BadalonaSpainCompleted
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainCompleted
Hospital Universitario Reina Sofia
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CórdobaSpainCompleted
Hospital Universitario Ramón y Cajal
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MadridSpainCompleted
Hospital General Universitario Gregorio Marañón
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MadridSpainCompleted
Hospital Universitario 12 de Octubre
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MadridSpainCompleted
Hospital Universitario Fundación Jiménez Díaz
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MadridSpainCompleted
University Clinical Hospital Virgen De La Arrixaca
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MurciaSpainCompleted
Hospital Universitario De Salamanca
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SalamancaSpainCompleted
Complexo Hospitalario Universitario De Santiago
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Santiago de CompostelaSpainCompleted
Hospital Clinico Universitario de Valencia
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ValenciaSpainCompleted
Fondazione Toscana Gabriele Monasterio
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PisaItalyCompleted

This page is information, not medical advice. Discuss any trial with your doctor.