跳至主要内容
临床试验/NCT03393793
NCT03393793已完成不适用

Heart Transplantation Registry of Pitié-Salpétrière University Hospital

Lee S Nguyen0 个研究点目标入组 566 人开始时间: 2009年1月1日最近更新:
适应症

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

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

发起方
Lee S Nguyen
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Lee S Nguyen

Principal Investigator

Groupe Hospitalier Pitie-Salpetriere

相似试验