Registry of Cell Therapy in Non-Ischemic Dilated Cardiomyopathy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Transplantation-free survival
研究概览
简要总结
Although several studies have demonstrated beneficial effects of stem cell therapy in patients with non-ischemic dilated cardiomyopathy, the long term benefits and predictors of response to therapy remain undefined. The aim of this registry is to pool long-term clinical data in patients with non-ischemic dilated cardiomyopathy undergoing autologous cell therapy in an attempt to better define predictors of response to such treatment.
详细描述
Registry will include all patients who underwent intracoronary or intramyocardial cell therapy as a part of clinical trials performed at UMC Ljubljana from January 2005 until January 2018. Patients will be followed on regular basis in a dedicated heart failure outpatient clinic, clinical data will be collected and stored in a secure central database. Data will be analyzed in periodic intervals by an independent Data monitoring board in an attempt to better define the predictors of clinical response to cell therapy in this patient population.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient inclusion criteria consisted of the following: age 18-65 years old, diagnosis of DCM according to the European Society of Cardiology position statement (9), optimal medical management for at least 6 months, left ventricular ejection fraction (LVEF) <40%, and New York Heart Association functional Class III on stable medical therapy for at least 3 months before referral.
排除标准
- •Patients with acute multi-organ failure or a history of hematologic neoplasms were not included.
结局指标
主要结局
Transplantation-free survival
时间窗: 5 years
Survival after 5 years without undergoing heart transplantation
次要结局
- Changes in left ventricular diastolic function(5 years)
- Changes in left ventricular ejection fraction(5 years)
- Changes in left ventricular dimensions(5 years)
- Changes in right ventricular function(5 years)
研究者
Bojan Vrtovec
Medical Director, Advanced Heart Failure and Transplantation Center
University Medical Centre Ljubljana