CTIS2023-504165-23-00进行中（未招募）1 期
Randomized double-blind trial to study the benefit of Colchicine in Patients with Acutely Decompensated Heart Failure - IMIB-CO-2020-01
Fundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia0 个研究点目标入组 302 人开始时间: 2023年2月21日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 302
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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)
研究者
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