NON-COMPLEMENT MEDIATED AMR vs. COMPLEMENT MEDIATED AMR: DOES DD-cfDNA/GEP SHOW A DIFFERENCE
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The level of dd-cfDNA in non-compliment mediated pAMR1 (H+) and complement mediated pAMR1 (I+) heart transplant rejection will be measured.
研究概览
简要总结
Heart Transplant recipients at Tampa General Hospital heart transplant program who have pAMR1(H+) or pAMR1(I+) rejection will have a DD-cfDNA /GEP sample obtained at the time of the rejection. The DD-cfDNA/GEP will then be drawn every month post treatment for the rejection until the DD-cfDNA/GEP level returns to normal. A total of fifteen recipients with pAMR1(H+) and fifteen recipients with pAMR1(I+) rejection will be included in the study which will last two years. The presence of HLA antibodies (DSA's) and the titers, presence of Autoantibodies, the measurement of cytokines IL2, IL4, IL6, IL 10, IL 17, TNF alpha, TGF beta, the presence of coronary artery vasculopathy, the time from transplant to the onset of the episode of AMR, time to resolution, the response to treatment and comparison to the DD-cfDNA/GEP level with pAMR2 and pAMR 3 rejections will be analyzed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have undergone Orthotopic Heart Transplantation who have pAMR1 rejection.
排除标准
- •Subjects less than 18 years old
结局指标
主要结局
The level of dd-cfDNA in non-compliment mediated pAMR1 (H+) and complement mediated pAMR1 (I+) heart transplant rejection will be measured.
时间窗: 2 years
The level of dd-cfDNA in non-compliment mediated pAMR1 (H+) and complement mediated pAMR1 (I+) heart transplant rejection will be measured and then compared statistically to each other via Students t test as well as to the level of dd-cf DNA before and after the rejection episode.
次要结局
- The level of inflammatory cytokines in non-compliment mediated pAMR1(H+) and compliment mediated pAMR1(I+) heart transplant rejection will be measured.(2 years)
- The presence of HLA antibodies (DSA's) and titer levels, autoantibodies and titer levels and coronary artery vasculopathy will be measured.(2 years)
研究者
Benjamin Mackie
Principal Investigator/Medical Doctor
Tampa General Hospital