Donor-derived Cell Free DNA as a Potential New Biomarker in Cardiac Transplantation: Role in Acute Rejection
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 12
- 主要终点
- Association between dd-cfDNA levels and the presence of acute cellular rejection
研究概览
简要总结
FreeDNA-CAR is a prospective, observational multicenter study, that will include a total of 200 adult heart transplant (HT) patients from 14 centers in Spain. Our main objective is to test donor-derived Cell-Free DNA (dd-cfDNA) against endomyocardial biopsy (EMB) for the diagnosis of acute cellular rejection.
详细描述
All patients will be enrolled immediately after HT, and will undergo undergo routine surveillance EMB at 15 days, 1 month, 2, 3, 4, 6 and 12 months after HT. Simultaneously with each EMB, dd-cfDNA will be measured in plasma.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients > 18 years old who undergo heart transplant during the recruiting period
排除标准
- •Patients with moderate or severe Primary Graft Dysfunction
- •Patients on invasive mechanical ventilation 15 days after heart transplant
- •Patients on renal replacement therapy, continuous or periodic, 15 days after heart transplant
- •Heart Transplant due to a cardiomyopathy that could potentially recur on the graft (cardiac amyloidosis, Chagas disease or sarcoidosis, amongst others)
- •Multiorgan transplant
结局指标
主要结局
Association between dd-cfDNA levels and the presence of acute cellular rejection
时间窗: 1 year
Association between dd-cfDNA levels above a certain cut-point and the presence of treatable acute cellular rejection as determined by endomyocardial biopsy (graded by International Society of Heart and Lung Transplantation 2010 classification, grade \> 1R).
次要结局
- Area under curve for dd-cfDNA(1 year)
- Correlation between dd-cfDNA and antibody mediated rejection (AMR)(1 year)
- Association between dd-cfDNA and immunosuppressive (IS) treatment(1 year)
- Association between dd-cfDNA (%) and left ventricular ejection fraction(1 year)
- Determine the biomarker's kinetics at 15 days post-transplant(15 days)
- Association between dd-cfDNA levels and cytomegalovirus (CMV) infection(1 year)
- Determine a cut-off point of dd-cfDNA that allows to differentiate between acute cellular rejection (ACR) and antibody mediated rejection (AMR)(1 year)
研究者
Javier Segovia Cubero
Head of Cardiology Department
Puerta de Hierro University Hospital