Cardiac RadiothErapy For hEart faiLure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in left ventricular ejection fraction
研究概览
简要总结
Preliminary data suggests that patients suffering from advanced refractory heart failure (HF) could benefit from single low dose whole heart external beam radiotherapy (EBRT).
Objective: To explore in our center the efficacy of administering a EBRT treatment of 5Gy to the whole heart in patients with advanced and refractory HF. The hypothesis is that 5Gy EBRT to the whole heart can improve the left ventricular ejection fraction (LVEF) of these patients by a clinically relevant 5%.
Main study endpoints: The primary aim is to explore the efficacy of EBRT treatment for advanced refractory HF. Secondary endpoints include an assessment of safety, overall survival, hospital admissions, late toxicity, quality of life and the effect of the treatment on other heart function indicators (left ventricular volumes, NT-proBNP, Troponine, High sensitive CRP).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patient ≥ 18 years
- •Advanced refractory HF NYHA class II, III or IV
- •Stable HF for the last 6 months with maximal guideline-directed HF therapy
- •Ischemic or dilated cardiomyopathy
- •LVEF at baseline ≤ 35%
- •Ability to give a written informed consent and willingness to return for follow-up
排除标准
- •Eligible or in consideration for heart transplantation
- •Pregnancy or breastfeeding
- •Previous radiotherapy with cardiac involvement
- •Any condition that is deemed a contraindication in the judgment of the investigators
结局指标
主要结局
Change in left ventricular ejection fraction
时间窗: Baseline, week 6, week 12, and 6 months
The hypothesis, based on recent preclinical and clinical data, is that 5Gy whole heart radiotherapy in advanced refractory HF patients can improve the LVEF and increase QOL with a low to very low toxicity profile. The efficacy will be defined as an improvement of at least 5% of the LVEF over a period of 6 months.
次要结局
- Acute toxicity(toxicity occurring within 30 days after the radiation treatment.)
- Late toxicity(30 days to 6 months after the radiation treatment)
- Quality of life - SF-36(Baseline, 6 weeks, 12 weeks, and 6 months)
- Quality of life - MLWHF(Baseline, 6 weeks, 12 weeks, and 6 months)
- Acute toxicity(toxicity occurring within 30 days after the radiation treatment.)
- Quality of life - SF-36(Baseline, 6 weeks, 12 weeks, and 6 months)
- All-cause mortality(6 months after the radiation treatment)
- Late toxicity(30 days to 6 months after the radiation treatment)
- NT-proBNP levels(Baseline, week 6, week 12, and 6 months)
- Heart failure hospitalisation(Within 6 months after the radiation treatment)
- High-sensitive troponin levels(Baseline, 6 weeks, 12 weeks, and 6 months)
- Quality of life - MLWHF(Baseline, 6 weeks, 12 weeks, and 6 months)
- High-sensitivity C-reactive protein(Baseline, 6 weeks, 12 weeks, and 6 months)
- Left ventricular volumes(Baseline, 6 weeks, 12 weeks, and 6 months)
- Ventricular arrhythmia burden(Baseline, 6 weeks, 12 weeks, and 6 months)