Substudy of the the CANTOS Trial (Interleukin-1 Blockade With Canakinumab to Improve Exercise Capacity in Patients With Chronic Systolic Heart Failure and Elevated Hs-CRP; CACZ885M2301)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Peak oxygen consumption (VO2)
研究概览
简要总结
The proposed study is a sub-study of the CANTOS trial (A randomized, double-blind, placebo-controlled, event driven trial of quarterly subcutaneous canakinumab in the prevention of recurrent cardiovascular events among stable post-myocardial infarction patients with elevated high sensitivity C-reaction protein (hsCRP) [CACZ885M2301]).
The study proposes to perform serial Cardiopulmonary Exercise Tests (CPX) to prospectively measure changes in aerobic exercise capacity in patients with prior myocardial infarction (MI), elevated C reactive protein plasma levels, and symptomatic heart failure with reduced systolic function, who are enrolled in the main CANTOS trial and are randomly assigned to Canakinumab (3 different doses) or Placebo.
The subjects enrolled in this substudy will undergo repeated CPX and echocardiograms over the first 12 months of the CANTOS trial. The subjects will received the experimental treatment as randomized in the main CANTOS trial and they will not receive any additional experimental treatment as part of the sub-study.
This study is a an Investigator-initiated (Dr. Abbate) single-center (Virginia Commonwealth University) sub-study of the CANTOS trial, supported by Novartis pharmaceuticals.
详细描述
Patients enrolled in the CANTOS trial (with prior acute myocardial infarction [>30 days] and elevated C reactive protein levels [CRP>2mg/l]) who also have reduced left ventricular ejection fraction (LVEF<50%) and are symptomatic for heart failure (New York Heart Association symptoms class II-III) will be offered to take part in this sub-study at the Virginia Commonwealth University site.
As part of the sub-study, patients will undergo a cardiopulmonary exercise test (CPX) at baseline prior to initiation of treatment, then repeated at 3 and 12 months, and a transthoracic echocardiogram at baseline and at 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all criteria listed in the CANTOS trial (CACZ885M2301)
- •left ventricular ejection fraction <50%
- •symptoms of heart failure (NYHA class II-III)
排除标准
- •all criteria listed in the CANTOS trial (CACZ885M2301)
- •inability to complete a treadmill exercise test
- •conditions preventing interpretation of the cardiopulmonary test (arrhythmias, ischemia, hypertension, pulmonary disease)
研究组 & 干预措施
Canakinumab 300 mg quarterly
Canakinumab 300 mg quarterly
干预措施: Cardiopulmonary exercise test (Other)
Placebo
Placebo
干预措施: Cardiopulmonary exercise test (Other)
Placebo
Placebo
干预措施: Echocardiogram (Other)
Canakinumab 50 mg quarterly
Canakinumab 50 mg quarterly
干预措施: Cardiopulmonary exercise test (Other)
Canakinumab 50 mg quarterly
Canakinumab 50 mg quarterly
干预措施: Echocardiogram (Other)
Canakinumab 150 mg quarterly
Canakinumab 150 mg quarterly
干预措施: Cardiopulmonary exercise test (Other)
Canakinumab 150 mg quarterly
Canakinumab 150 mg quarterly
干预措施: Echocardiogram (Other)
Canakinumab 300 mg quarterly
Canakinumab 300 mg quarterly
干预措施: Echocardiogram (Other)
结局指标
主要结局
Peak oxygen consumption (VO2)
时间窗: 3 months
Difference in the interval change from baseline in peak VO2 at 3 months following a single dose of CANAKINUMAB 50 mg subcutaneous, 150 mg subcutaneous, or CANAKINUMAB 300 mg subcutaneous \[all three groups combined\] when compared with the interval change in placebo (placebo-corrected interval change).
次要结局
- Peak VO2 change(12 months)
- Diastolic function change(12 months)
- Ventilatory efficiency (VE/VCO2 slope) change(12 months)
- OUES(12 months)
- LVEF change(12 months)