Prospective Pilot Single-center Study to Evaluate the Safety and Efficacy of Low-dose Radiotherapy in Patients With Heart Failure
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Change from Baseline in the Left Ventricular Ejection Fraction
研究概览
简要总结
The primary goals of this clinical trial are to evaluate the safety and efficacy of a low dose whole-heart radiotherapy with a single fraction in ten participants with advanced heart failure.
详细描述
The primary objectives of this prospective phase I/II, single-center study, are to evaluate the safety and efficacy of low dose whole-heart radioherapy (RT) in ten patients with heart failure (HF).
Eligible patients must have clinical-laboratory diagnosis of New York Heart Association grade II or III chronic systolic HF with ejection fraction < 40% and refractoriness to standard clinical treatment defined as the persistence of signs and symptoms of HF despite optimized drug therapy.
All subjects will receive whole-heart RT for a single-dose of 5 Gy. The primary efficacy endpoint will be determined by evaluating the impact of RT on left ventricular ejection fraction by high-resolution cardiac MRI. Radioinduced toxicity results (pericarditis, myocardial infarction and fatigue) will be classified according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
All patients will undergo more comprehensive clinical, laboratory and imaging evaluation at 2 time points: up to 2 weeks before and 12 weeks after RT. At each moment, a clinical evaluation will be carried out, blood tests will be checked (blood count and serum levels of urea, creatinine, sodium, potassium, calcium, albumin, magnesium, troponin, creatine kinase MB, C-reactive protein and type B natriuretic peptide) and echocardiography will be performed. Cardiac MRI will be performed just 4 weeks after RT.
Although the risk of late toxicity from RT is low due to the dose administered and high short-term mortality associated with HF itself, all patients will be followed by the research group after the period of additional clinical-laboratory evaluations scheduled in the first 12 weeks after RT. After 12 weeks, all patients will be followed by the research group for clinical-laboratory evaluation every 6 months. Considering the median survival reported in this group of patients, approximately 2 years, the estimated total duration of the study is 5 years.
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
- •Age >18 years;
- •Clinical and laboratory diagnosis of chronic systolic HF grades II or III of the New York Heart Association with ejection fraction <40%;
- •Refractoriness to standard clinical treatment; defined as the persistence of HF signs and symptoms despite optimized drug therapy.
- •Patient consent to participate in the study.
- •Agreement to adopt contraceptive practices/methods until the end of the intervention for women of childbearing age.
排除标准
- •Patients who have undergone any type of previous radiotherapy in the thoracic region;
- •Patients who have undergone heart transplants;
- •Contraindications for magnetic resonance imaging (MRI), such as the use of metal implants or prostheses.
- •Pregnant patients.
研究组 & 干预措施
Single arm
Low Dose Radiotherapy
干预措施: Radiation Therapy (Radiation)
结局指标
主要结局
Change from Baseline in the Left Ventricular Ejection Fraction
时间窗: 4 weeks after radiotherapy
Impact of RT on left ventricular ejection fraction by high-resolution cardiac MRI
Treatment-related Adverse Effects as assessed by CTCAE v5.0
时间窗: Evaluation at 2, 4, 12 weeks and every 6 months unti 5 years after radiotherapy
Pericarditis, myocardial infarction and fatigue) will be classified according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
次要结局
未报告次要终点