Association Between TTV Viral Load and the Occurrence of Infections and Rejection in Heart Transplant Recipients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Composite outcome : Infections or Rejections
研究概览
简要总结
This prospective, multicenter, non-interventional trial aims to study the association between TTV viral load and the occurrence of rejection or infection during the first year after transplantation.
The TTV viral loads, taken once a month during the first year after the transplant, will be measured at the end of the study.
详细描述
TTV (Torque Teno Virus) is a ubiquitous virus that is not associated with any disease. A correlation exists between the level of TTV replication and the subject's immunocompetence: weak or non-existent in immunocompetents, very high in immunocompromised patients. In heart transplant patients, pharmacological dosing of immunosuppressants prevents their toxic manifestations but is not correlated with individual immune competence. Only clinical manifestations of overdose (infections) or under dosage (rejections) currently allow optimization of immunosuppressants. A predictive biomarker of these clinical manifestations upstream of their appearance would revolutionize the management of these patients.
The TTV fulfills the conditions to be an ideal biomarker: classic blood sampling, possible follow-up in all patients, low cost, carrying out the analysis on already existing molecular biology platforms, reproducibility of inter- and intra-laboratory results, defined thresholds for the reliable interpretation of the results.
We believe that this marker will provide the clinician with a useful tool for the management of immunosuppressants and the patient with personalized medicine which will allow their management to be individualized. If this study confirms the expected results, then it will allow, secondly, the setting up of interventional studies to validate the TTV viral load as a biomarker, and a tool for piloting immunosuppressive treatment.
The TTV viral load of heart transplant patients will be follow during the first year after transplantation.
A tube of blood will be taken during the transplant and then once or twice a month.
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
- •Age ≥18 years
- •Heart transplant only
- •First transplant
- •Patient not having objected to carrying out the research
- •Affiliated to a French Health Insurance system.
排除标准
- •Patient transplanted from more than one solid organ
- •Patient who has already been transplanted before
- •Patient under guardianship or curatorship
- •Patient under legal protection
- •Pregnant or breastfeeding woman
研究组 & 干预措施
All the patients included in the study
50 patients, at least 18 years old, first heart transplant
干预措施: Collection of EDTA blood sample (5 to 7 ml) (Other)
结局指标
主要结局
Composite outcome : Infections or Rejections
时间窗: 12 months
The primary endpoint is a composite endpoint defined as time to infections (first and recurrences) or rejections (first and recurrences) within the 12 months post-transplant: * Infections are defined as viral Infections , bacterial and parasitic infections requiring the establishment of anti-infectious treatment or hospitalization * Rejections are defined as acute type 2R or 3R cell rejections according to the ISHLT classification
次要结局
- Rejections(12 months)
- Infections(12 months)
- TTV viral load(12 months)
- Immunosuppressant level(12 months)
- TTV viral load(3 months)
- Immunosuppressant level(3 months)