2023-506675-96-00招募中3 期
COLchicine and Thiamine in Heart Failure due to Ischemic Heart Disease (COLT-HF)
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 17
- 主要终点
- Colchicine arm: Composite of CV death, HF event, or ischemic CV event (defined as myocardial infarction, ischemic stroke, or arterial revascularization)
研究概览
简要总结
In an RCT of individuals with HF secondary to ischemic heart disease (IHD):
- To examine the impact of colchicine compared to placebo on the composite outcome of CV death, a HF event (defined a HF hospitalization or urgent HF visit), or ischemic cardiovascular events (myocardial infarction, ischemic stroke, or arterial revascularization).
- To examine the impact of thiamine on the composite outcome of CV death, or HF hospitalization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Colchicine
- 盲法
- Double (Subject, Monitor, Investigator)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age greater than or equal to 45 years
- •Documented ischemic heart disease as the etiology of HF, which includes: a) a history of CAD, and b) determination of the cause of HF to be due to IHD based on local investigator assessment
- •NYHA class II-IV symptoms
- •Documented LVEF less than or equal to 45% within 1 year prior to enrollment
- •Optimal medical treatment for HF as per local clinical practice
- •Participants can be enrolled in the ambulatory or hospitalized setting
排除标准
- •Female who is pregnant, breast-feeding or is considering becoming pregnant during the study
- •Concurrent use of other experimental pharmacologic agents
- •Regular or required use colchicine or thiamine for other clinical indications
- •History of allergic reaction to colchicine or to thiamine; or current or planned use of cyclosporine, verapamil, diltiazem, azole antifungal, macrolide antibiotic (except azithromycin), or HIV protease inhibitor
- •Use of a ventricular assist device or prior heart transplant
- •Severe valvular disease
- •Coronary revascularization (coronary artery bypass graft surgery or percutaneous coronary intervention) within the 4 weeks prior to enrollment, or planned within the next 4 weeks.
- •Chronic and severe renal dysfunction defined as eGFR < 15 mL/min/1.73m2 based on local laboratory measurement done within 6 months prior to run-in
- •History of liver cirrhosis
- •Active malignancy (excluding basal cell or treated squamous cell carcinoma of the skin) requiring treatment and with a life-expectancy of <2 years.
结局指标
主要结局
Colchicine arm: Composite of CV death, HF event, or ischemic CV event (defined as myocardial infarction, ischemic stroke, or arterial revascularization)
Colchicine arm: Composite of CV death, HF event, or ischemic CV event (defined as myocardial infarction, ischemic stroke, or arterial revascularization)
Thiamine arm: Composite of CV death or HF event
Thiamine arm: Composite of CV death or HF event
次要结局
- All cause death, hospitalization
- Serious adverse events
- Side effects or adverse events resulting in study drug discontinuation
研究者
Philip Joseph
Scientific
Hamilton Health Sciences Corporation
研究点 (17)
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