Efficacy and Safety of Colchicine in Patients with Heart Failure with Preserved Ejection Fraction and Inflammation
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change in KCCQ-CS scores
研究概览
简要总结
The main purpose of the CHIPS trial is to evaluate the efficacy and safety of colchicine in heart failure with preserved ejection fraction (HFpEF) patients with inflammation, including the effects of colchicine on circulating inflammatory markers, cardiac structure, cardiac function, clinical symptoms and exercise capacity in HFpEF patients.
详细描述
HFpEF is a disease with complex pathophysiological mechanisms, and inflammation has been found to be strongly associated with the onset and progression of HFpEF. Anti-inflammatory treatments begin to cut a striking figure in cardiovascular disease therapy. The LoDoCo2 trial showed a significant prognostic improvement of colchicine in patients with chronic coronary artery disease, and the latest COLICA trial, showed that 8 weeks of colchicine treatment significantly reduced levels of circulating inflammatory markers in patients with decompensated heart failure without serious adverse effects. However, at present, the efficacy and safety of colchicine for the treatment of HFpEF remains unclear. The CHIPS trial is a multi-center, randomized, open-label clinical trial. The aim of the study is to evaluate the efficacy and safety of colchicine in patients with heart failure with preserved ejection fraction and inflammation. The investigators proposed to assess changes in KCCQ scores, NT-proBNP levels, echocardiography and plasma inflammatory marker levels in HFpEF patients treated with or without colchicine to evaluate the efficacy of colchicine in HFpEF treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Left ventricular ejection fraction measured by echocardiography ≥ 50%
- •Objective evidence of structural of functional abnormalities measured by echocardiography: 1)LVMI≥95 g/m2 in female and ≥115 g/m2 in male or 2)LAVI greater than 29ml/m2 in sinus rhythm or greater than 40ml/m2 in atrial fibrillation or 3)Average E/e' greater than 14 or 4)TR velocity greater than 2.8 m/s
- •Patients with elevated NT-proBNP levels 24 hours after discontinuing intravenous diuretics: ≥300 pg/ml in patients with sinus heart rate; ≥600 pg/ml in patients with atrial fibrillation
- •Both outpatient and admitted patients can be considered for enrollment. All patients must occurred worsening heart failure event within 30 days prior to randomization and a current NYHA cardiac function class II-IV
- •Patients with CRP levels greater than 2mg/L
- •Patient agrees to join and signs a written informed consent form
排除标准
- •Received colchicine treatment within one month prior to randomization
- •Acute coronary syndrome within 3 months prior to randomization, or history of pacemaker implantation, PCI, CABG within 3 months
- •eGFR less than 25 mL/min/1.73 m2
- •Liver function Child-Pugh class B or C
- •Patient has a history of previous allergy to colchicine or dapagliflozin / empagliflozin
- •Heart failure due to the following reasons: pericardial disease, pericardial effusion, myocarditis, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, and other rare cardiomyopathies such as Fabry disease
- •Combined diagnosis of gastric ulcer, ulcerative colitis, Crohn disease and other digestive disorders or combined gastrointestinal tumors
- •Plan to undergo cardiac surgery such as coronary revascularization, radiofrequency ablation of arrhythmias, valve replacement or other surgical procedures
- •Pregnant or breastfeeding women
- •The patient who is cognitively impaired and is unable to accurately complete the assessment and completion of the KCCQ scale with the assistance of a physician
- •Autoimmune diseases such as systemic lupus erythematosus, long-term adrenocorticotropic hormone treatment for other diseases such as Schihan syndrome, or need to accept immunosuppressive drugs and monoclonal antibodies such as IL-1 and IL-6
- •Patient with combined active solid tumor or hematological malignancy
- •Patient comorbidity with other conditions that may be confused with HFpEF symptoms, such as acute exacerbation of COPD
- •Admission with a well-defined infection (symptoms or pathogenetic evidence of infection, and leukocytes greater than 10*109/L)
- •Previously diagnosed with HFrEF (initial assessment of LVEF less than 40%) or diagnosed with LVimpEF
研究组 & 干预措施
Colchicine Treatment Group
This group is intended to include 100 patients, all of the patients will be given 5mg of once-daily the colchicine treatment on top of the SGLT2i treatment
干预措施: Colchicine 0.5 MG Oral Tablet Once Daily (Drug)
结局指标
主要结局
Change in KCCQ-CS scores
时间窗: Up to 12 weeks
Patients were assessed for symptom improvement by Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CS)
Change in 6-MWD
时间窗: Up to 12 weeks
Improvement in patients exercise capacity assessed by 6-minuet walk distance
Change in serum CRP levels
时间窗: Up to 12 weeks
Change in serum C-reactive protein levels
次要结局
- Change in serum NT-proBNP levels(Up to 12 weeks)
- Change in serum IL-1β levels(Up to 12 weeks)
- Change in serum IL-6 levels(Up to 12 weeks)
- Change in serum TNF-α levels(Up to 12 weeks)
- Change in cardiac structure(Up to 12 weeks)
- Change in cardiac function(Up to 12 weeks)
- Worsening heart failure events(Up to 12 weeks)
研究者
Dongying Zhang
Director
Chongqing Medical University