Status:
COMPLETED
Randomized Double-blind Trial to Study the Benefit of Colchicine in Patients With Acutely Decompensated Heart Failure
Lead Sponsor:
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Conditions:
HEART FAILURE
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 t...
Detailed Description
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 decompensa...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 17 2024
Estimated Enrollment :
279 Patients enrolled
Trial Details
Trial ID
NCT04705987
Start Date
February 8 2021
End Date
May 17 2024
Last Update
May 22 2024
Active Locations (1)
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1
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, Spain, 30120