Detecting and Treating Subclinical Anthracycline Therapy Related Cardiac Dysfunction in Low Income Country
试验速览
- 阶段
- 3 期
- 入组人数
- 50
- 主要终点
- Cardiac function
研究概览
简要总结
The objective of this research is to describe the burden of subclinical anthracycline therapy related cardiac dysfunction( ATRCD) by applying international guideline on Uganda cancer patient and to evaluate the significance of treating subclinical ATRCD with carvedilol.
详细描述
Specific objectives:
- To determine the incidence of subclinical ATRCD among cancer patient who receives Anthracycline therapy.
- To compare the changes of GLS value between hypertension and non hypertension cancer patient at the competition of the anthracycline therapy.
- To determine the correlation of conventional echocardiograghy(ECHO) parameters (MAPSE, S') with GLS, and their ability to diagnose or rule out subclinical ATRCD.
- To determine the correlation of oxidative stress with cardiac function(GLS value) in patients who receives Anthracycline therapy
- To describe the cardioprotective effect of carvedilol in patients with subclinical ATRCD.
METHODS This is going to be two prospective cohort study (cohort 1 and 2) followed by a randomized controlled trial (cohort 3).
To achieve objective 1 ,3 and 4, Cohort 1 will consecutively recruit 300 adult non hypertension cancer patients who are going to receive anthracycline therapy.
To achieve objective 2, Cohort 2 will consecutively recruit 53 adult hypertension cancer patients (group H) and 106 non hypertension controls (group N) who are going to receive anthracycline therapy. Controls will be recruited from cohort 1 by systemic sampling( Choosing the 2nd patients as they are enrolled in cohort 1).
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between and include 18 and 50 years.
- •Newly diagnosed cancer patients who develop subclinical ATRCD during cardiac follow up.
排除标准
- •Patient who has been taking carvedilol prior to the study
- •Patient who self report to be allergic to carvedilol
- •Systolic blood pressure < 90mmHg
- •Heart Rate < 50 beat per minute
- •Patient who is asthmatic or has chronic obstructive lung disease
- •Pregnant woman
研究组 & 干预措施
Treatment Group
Study participants will receive carvedilol for a period of 6 month. The initial dosage of carvedilol will be 3.125mg twice daily. Dosage will be titrated up two weekly until the maximum tolerable dose or ceiling dose of 25mg twice daily has been reached.
干预措施: Carvedilol (Drug)
结局指标
主要结局
Cardiac function
时间窗: 6 months
This will be measured by mean GLS(Global Longitudinal strain) value.
次要结局
未报告次要终点