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

NCT04705987 | Completed Phase 3

• 1 other identifier: IMIB-CO-2020-01
• Study Type: interventional
• Target: 279
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HEART FAILURE

Outcome Measures

Primary Outcomes (1)

• Decreased NT-proBNP levels

  Decreased (N-terminal prohormone of brain natriuretic peptide) levels

  Up to 8 weeks

Secondary Outcomes (9)

• Improvement of clinical stability

  Up to 8 weeks

• Improvement of clinical stability

  Up to 8 weeks

• Improvement of clinical stability

  Up to 8 weeks

• Improvement of clinical stability

  Up to 8 weeks

• Improvement of clinical stability

  Up to 8 weeks

Study Arms (2)

Experimental

EXPERIMENTAL

Colchicine 0.5 mg

Drug: Colchicine 0.5 MG

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Colchicine 0.5 MG DRUG

Colchicine 0.5 mg/24h Treatment 8 weeks

Experimental

Placebo DRUG

Placebo 1c/24h Treatment 8 weeks

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia: lead

Study Sites (1)

Hospital Clínico Universitario Virgen de la Arrixaca

Murcia, 30120, Spain

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Study Officials

• Domingo Pascual Figal, MD

  Hospital Universitario Virgen de la Arrixaca

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: January 12, 2021
• Study Start: February 8, 2021
• Primary Completion: May 17, 2024
• Study Completion: May 17, 2024
• Last Updated: May 22, 2024

Record last verified: 2023-09

Locations

ES (1)