Prospective Multidisciplinary Observational Trial of Cardiotoxicity in Patients Undergoing Anticancer Therapy.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- All-cause mortality
研究概览
简要总结
Advances in treatment have led to improved survival of patients with cancer, but have also increased morbidity and mortality due to cancer treatment side effects. Cardiotoxicity is one the most frequent side effect which may lead to premature morbidity and death among cancer survivors. The most concerning cardiovascular complications of cancer therapy is myocardial dysfunction, leading to heart failure, and fatal arrhythmias, especially those induced by QT-prolonging drugs.
PROMETEY (PROspective Multidisciplinary obsErvational Trial of cardiotoxicity in patiEnts undergoing anticancer therapy) - is Russian multicenter observational study assessing cardiotoxicity and its clinical, biochemical and genetic factors in patients on cancer therapy.
The objectives of the study are:
- to reveal prevalence of cardiotoxic effects of cancer therapy in routine clinical practice in Russian Federation,
- to assess contribution of these effects to mortality of patients on cancer therapy,
- to evaluate clinical and economic consequences of cardiotoxicity in patients with cancer,
- to develop an individualized model of cardiotoxicity risk factors based on clinical and laboratory parameters.
Patients: 400 cancer patients with toxic cardiomyopathy and 100 patients with idiopathic or family dilated cardiomyopathy.
Study duration: 60 months. All patients will undergo complex examination after signing informed consent form(ICF): physical exam, echocardiography with speckle tracking analysis, ambulatory 48-hours ECG monitoring, biochemistry, analysis of biomarkers of myocardial injury, fibrosis and inflammation.
Primary endpoint: all-cause mortality, heart transplantation, cardioverter-defibrillator implantation, hospitalization with heart failure decompensation.
Secondary endpoints:
- thromboembolism,
- fatal/ nonfatal myocardial infarction, stroke,
- sudden cardiac death,
- surgical therapy of heart failure or arrhythmias,
- cardiovascular death,
- all-cause mortality,
- heart transplantation,
- cardioverter-defibrillator implantation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •written informed consent form (ICF),
- •Eastern Cooperative Oncology Group (ECOG) scale 0-3,
- •patients with verified cancer on or planned to be on chemotherapy including anthracyclines,
- •sufficient bone marrow function, including: absolute neutrophils > 1.5*10^9/l, platelets > 100*10^9/l, hemoglobin > 9 g/dl,
- •sufficient liver function, including: total bilirubin < 1.5*upper normal value, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 upper normal value,
- •sufficient renal function, including: creatinine clearance > 50 ml/min.
- •For control group:
- •verified non-toxic dilated cardiomyopathy.
排除标准
- •refusal of patient,
- •coma, delirium,
- •mental disorders,
- •left chest radiation therapy,
- •metastases in central nervous system.
结局指标
主要结局
All-cause mortality
时间窗: During all observational period (60 months)
Death of patient from all causes.
Heart transplantation
时间窗: During all observational period (60 months).
Heart transplantation associated with heart failure or toxic cardiomyopathy decompensation.
Cardioverter-defibrillator implantation
时间窗: During all observational period (60 months).
Implantation of cardioverter-defibrillator associated with life-threatening ventricular arrhythmias.
Hospitalization with heart failure decompensation
时间窗: During all observational period (60 months)
Hospitalization of patient due to decompensation of heart failure.
次要结局
- Sudden cardiac death(During all observational period (60 months).)
- Stroke(During all observational period (60 months).)
- Cardiovascular death(During all observational period (60 months).)
- Myocardial infarction(During all observational period (60 months).)
- Thromboembolism.(During all observational period (60 months).)
- Surgical therapy of heart failure or arrhythmias(During all observational period (60 months).)