Remote Ischaemic Preconditioning in Paediatric Cancer Patients Receiving Anthracycline Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- High sensitivity cardiac troponin T (hs-cTnT)
研究概览
简要总结
Survival rates of children with cancers have improved significantly in the recent few decades. Nonetheless, the side effect of this class of drugs on heart function remains to be an issue of concern. Exploration of new strategies to protect the heart in the long term is therefore of paramount importance in children undergoing treatment of cancers. Previous cardioprotective interventions hav focused on changing the formulation or rate of administration of anthracyclines but with no observable benefits. While dexrazoxane, an iron chelator, has shown to reduce cardiotoxic outcomes, there remains worries of an association between dexrazoxane use and an increased risk of developing secondary malignancies. Recently, the clinical application of remote ischaemic preconditioning (RIPC) as a non-invasive and an easily applicable non-pharmacological myocardial protective intervention has gained increasing interest. Remote ischaemic preconditioning is the phenomenon in which brief episodes of reversible ischaemia and reperfusion applied to one vascular bed render resistance to ischaemia reperfusion injury of tissues and organs distant away. It can be achieved by repeated 5-minute cycles of inflation and deflation of blood pressure cuff placed over the arm or leg to induce limb ischaemia and reperfusion injury. It is noteworthy that anthracycline cardiotoxicity and myocardial reperfusion injury occur through similar pathways. Hence, the investigators hypothesize that RIPC may reduce myocardial injury in children receiving anthracycline chemotherapy for childhood malignancies. The proposed study aims to conduct a parallel-group blinded randomized controlled trial study to investigate whether RIPC may reduce heart damage in childhood cancer patients undergoing anthracycline-based treatment, and to determine the effect of RIPC on the changes in levels of cardiac troponin T, and on the occurrence of clinical cardiovascular events and echocardiographic indices.
详细描述
Remote ischemic preconditioning (RIPC) protocol will be induced at baseline and before each dose of anthracycline cardiac surgery and once before induction of anesthesia by 3 cycles of 5-min upper or lower limb ischemia and 5-min reperfusion using a blood-pressure cuff inflated to 15 mmHg above the systolic blood pressure for 5 minutes followed by 5 minutes of cuff deflation to 0 mmHg.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged 4 to 18 years old
- •newly diagnosed patients with solid tumours or haematological malignancies referred for anthracycline-based chemotherapy
- •no history of being treated with anthracycline-based regimens in the past.
排除标准
- •existence of congenital or acquired heart disease
- •presence of syndromal disorders
- •abnormal baseline echocardiographic assessment
- •peripheral vascular disease that renders RIPC impossible
- •a platelet count <30,000/µL.
结局指标
主要结局
High sensitivity cardiac troponin T (hs-cTnT)
时间窗: hs-cTnT will be measured at baseline, and at 3 months after completion of all anthracycline. The change from baseline hs-cTnT to at 3 months after completion of all anthracycline will be measured.
Biomarker of myocardial injury
次要结局
- Occurrence of clinical cardiovascular events(at baseline, within 1 week and at 3 months after completion of all anthracycline treatment.)
- Echocardiographic assessment of left ventricular function(Echocardiographic assessment will be performed at baseline, and within 1 week and at 3 months after completion of all anthracycline treatment.)
研究者
Professor Yiu-fai Cheung
Clinical Professor
The University of Hong Kong