MuLtimodality EvaluatiOn of aNtibody mEdiated Damage in Heart Transplantation (LEONE-HT)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
- 试验地点
- 3
- 主要终点
- Histology findings with transmission electron microscopy (TEM)
研究概览
简要总结
Cross-sectional evaluation of antibody mediated injury in heart transplantation patients through a multimodal approach: electron microscopy, optic microscopy, immunohistochemistry techniques, transthoracic echocardiography, cardiac magnetic resonance, pressure guide wire, intravascular ultrasound
详细描述
Heart transplant survival has barely improved in the last decades and unsatisfactory for a large proportion of heart transplant recipients. The development of leukocyte antigen antibodies (anti-HLA) in the post-transplant patient is associated to the main causes of graft dysfunction. The mechanisms of this damage are unclear and there's no effective treatment.
The investigators aim is to identify early markers of graft injury through a complete morphological and functional evaluation with histological analysis, immunological assays, advanced imaging techniques and invasive evaluation of coronary vasculature in patients with anti-HLA compared to matching controls.
The investigators propose a cross-sectional study within a large heart transplant cohort. This is a multicentric observational multimodal study. The investigators aim is to establish early characteristics of antibody mediated damage and set the bases for future studies looking for new treatment targets.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Heart transplant recipients
- •"De novo" antiHLA detection (after heart transplant):
- •Mean fluorescence intensity (MFI)) > 2000 for donor-specific antibodies
- •Standard fluorescence intensity (SFI) > 150 000 for non-donor specific antibodies
- •Detailed immunological history:
- •Determination of anti-HLA antibodies before heart transplant.
- •Serial determination of anti-HLA antibodies during heart transplantation follow-up
- •Known HLA typing of the donor.
- •Non-exposed: Heart transplant procedure contemporary to the index case with negative anti-HLA antibodies.
排除标准
- •Recipient of a second HT
- •Multiple organ transplantation
- •Unknown immunological history
- •Recipients sensitized with anti-HLA antibodies against donor's HLA before the transplant
- •CMR contrast will not be administered in patients with glomerular filtration rate < 30 ml/kg/1.73m2
- •Patients with implanted cardiac devices or any other magnetic resonance non-compatible metallic prosthetic material will not undergo CMR.
结局指标
主要结局
Histology findings with transmission electron microscopy (TEM)
时间窗: 14 days
Detailed description of the antibodies-mediated graft injury depending on exposition-time through a detailed evaluation
Histology findings with optic microscopy (OM)
时间窗: 14 days
Detailed description of the antibodies-mediated graft injury depending on exposition-time through a detailed evaluation
Histology findings with immunohistochemistry (IHQ) techniques.
时间窗: 14 days
Detailed description of the antibodies-mediated graft injury depending on exposition-time through a detailed evaluation
次要结局
- Coronary allograft vasculopathy (CAV 2)(14 days)
- Microvascular function (pressure guidewire)(14 days)
- Microvascular function (pressure guidewire 2)(14 days)
- Microvascular function (cardiac magnetic resonance)(14 days)
- Myocardial fibrosis (cardiac magnetic resonance 2)(14 days)
- Increased water content (intracellular edema)(14 days)
- Myocardial fibrosis (cardiac magnetic resonance)(14 days)
- Myocardial fibrosis (echocardiography)(14 days)
- Serum markers of fibrosis(14 days)
- Coronary allograft vasculopathy (CAV)(14 days)
研究者
Juan Francisco Delgado Jimenez
Medical Director of Heart Transplant programme MD, PhD
Hospital Universitario 12 de Octubre