Stereotactic Ablative Radiotherapy in Patients With Hypertrophic Obstructive Cardiomyopathy: First in Man Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Safety of stereotactic ablative radiotherapy
研究概览
简要总结
Hypertrophic obstructive cardiomyopathy (HOCM) is an inherited myocardial disease which leads to the muscle in the wall of the heart growing and thickening to the point that it blocks blood flow exiting the heart with increasing risk of sudden cardiac death, heart failure, and atrial fibrillation. Surgical septal myectomy and alcohol septal ablation are two invasive therapies for drug-refractory symptomatic patients with HOCM. Unfortunately, some patients may be unsuitable for both the two procedures. Recently, stereotactic ablative radiotherapy, usually used for the treatment of tumours, was confirmed to be feasible, safe and effective in destroying abnormal tissue in heart by targeting high energy heavy ion beams at a specific area of the body precisely. In this study we will determine whether radiation ablation, can be used to destroy the thick heart muscle at the point of obstruction safely and effectively.
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
- •Male or female aged ≥ 18 years
- •Drug-refractory symptomatic patients with HOCM
- •Willing and able to give written informed consent
排除标准
- •Enrolled in another clinical study.
- •Patient unable to tolerate lying flat for one hour
- •Pregnant Or Lactating Women
- •With other contraindications for receive stereotactic ablative radiotherapy
结局指标
主要结局
Safety of stereotactic ablative radiotherapy
时间窗: 3 months
The primary safety endpoint is defined as serious adverse events (SAEs) that are possibly/probably/definitely related to study treatment, based on previously published data for expected invasive alcohol septal-ablation procedures.
次要结局
- Assessment of MACE endpoints(1, 3, 6 and 12 months)
- Development of complete heart block, atrial or ventricular arrhythmias(1, 3, 6 and 12 months)
- Change in LVOT gradient(1, 3, 6 and 12 months)
- Change in exercise capacity(1, 3, 6 and 12 months)
- Change in LV wall thickness(1, 3, 6 and 12 months)
研究者
Shenghua Zhou
Professor
Second Xiangya Hospital of Central South University
