BridgeMD
Randomized double-blind trial to study the benefit of Colchicine in Patients with Acutely Decompensated Heart Failure
EU CTIS ID: 2023-504165-23-00
What this study is testing
To study if the administration of colchicine 0.5mg colchicine vs placebo in patients with decompensated HF is associated with decrease in NT-proBNP concentrations at 8 weeks after hospital discharge, as a biomarker of clinical stability and risk.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Unscheduled visit for symptoms and / or congestive signs of HF that require treatment with intravenous diuretics (at least 40 mg intravenous furosemide)
- 2. Clinical evidence, by symptoms or signs, and / or radiological of congestion.
- 3. NT-proBNP concentration greater than 900 pg / ml at screening visit.
- 4. Age over 18 years
- 5. Patients who have given their informed consent in writing.
You likely can't join if
- 1. Severe valve disease with indication for surgical repair.
- 10. 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
- 11. 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.
- 12. Patient with a history of allergic reactions or significant sensitivity to colchicine.
- 13. Chronic treatment with immunosuppressants, corticosteroids, interleukin-1 antagonists in the 6 months prior to inclusion.
- 14. 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.
See the full eligibility criteria
- 1. Unscheduled visit for symptoms and / or congestive signs of HF that require treatment with intravenous diuretics (at least 40 mg intravenous furosemide)
- 2. Clinical evidence, by symptoms or signs, and / or radiological of congestion.
- 3. NT-proBNP concentration greater than 900 pg / ml at screening visit.
- 4. Age over 18 years
- 5. Patients who have given their informed consent in writing.
- 1. Severe valve disease with indication for surgical repair.
- 10. 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
- 11. 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.
- 12. Patient with a history of allergic reactions or significant sensitivity to colchicine.
- 13. Chronic treatment with immunosuppressants, corticosteroids, interleukin-1 antagonists in the 6 months prior to inclusion.
- 14. 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.
- 15. 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.
- 2. Extracardiac disease with estimated vital prognosis of less than 1 year.
- 3. Inflammatory bowel disease (Crohn's disease or ulcerative colitis), diarrhea chronic or malabsorption.
- 4. Rheumatic inflammatory disease.
- 5. Serious gastrointestinal disorders
- 6. Stomach ulcer
- 7. Hematological disorders, such as blood dyscrasias
- 8. Previous neuromuscular disease
- 9. Severe renal failure (glomerular filtration rate <30 ml / kg / min / 1.73m2)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.