Heart Transplantation Registry of Pitié-Salpétrière University Hospital
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 566
- 主要终点
- Acute kidney injury (AKI)
研究概览
简要总结
Heart transplantation (HTx) is a procedure which is hindered by several complications. The HEARTS registry aims to allow the analysis of risk factors of all post-HTx complications. It consists in an exhaustive data collection at the moment of inclusion, i.e. HTx, knowing that patients underwent a full-fledged evaluation beforehand to evaluate their aptitude to being transplanted.
Post-HTx complications include but is not limited to: all-cause mortality, AMR, ACR, CAV, AKI, sepsis, cancer, psychological disorders, metabolic disorders.
详细描述
Heart transplantation (HTx) is a procedure which is hindered by several complications. The HEARTS registry aims to allow the analysis of risk factors of all post-HTx complications. It consists in an exhaustive data collection at the moment of inclusion, i.e. HTx, knowing that patients underwent a full-fledged evaluation beforehand to evaluate their aptitude to being transplanted.
Post-HTx complications include but is not limited to: all-cause mortality, AMR, ACR, CAV, AKI, sepsis, cancer, psychological disorders, metabolic disorders.
To do so, patients are routinely monitored several times per year, the frequency of which depends on the proximity to the HTx.
An endomyocardial biopsy is performed 3 times per month starting on day 15 until day 65 after HTx, then once every 20 days until four months, then monthly until six months, then once every 45 days until year 1, and every 3 months thereafter until year 2. Afterwards, they become twice per year until year 5, then once a year.
An echocardiography is performed for every visit, with a complete blood analysis, including HLA antibodies screening with DSA evaluation, virologic evaluation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Heart transplantation
排除标准
- 未提供
结局指标
主要结局
Acute kidney injury (AKI)
时间窗: up to five years after inclusion
AKI, defined by a KDIGO criteria
All-cause mortality
时间窗: up to five years after inclusion
all-cause mortality
Antibody mediated rejection (AMR)
时间窗: up to five years after inclusion
AMR, biopsy-proven
Acute cellular rejection (ACR)
时间窗: up to five years after inclusion
ACR, biopsy-proven
Cardiac allograft vasculopathy (CAV)
时间窗: up to five years after inclusion
CAV, defined ISHLT
Severe sepsis or septic shock
时间窗: up to five years after inclusion
As defined by Surviving Sepsis Campaign
次要结局
未报告次要终点
研究者
Lee S Nguyen
Principal Investigator
Groupe Hospitalier Pitie-Salpetriere
