跳至主要内容
临床试验/NCT07125703
NCT07125703进行中(未招募)不适用

Observational Study With Additional Procedures: Metabolomic and Ultrastructural Findings of Allograft in Heart Transplantation and Their Correlation With Graft Dysfunction.

Fondazione IRCCS Policlinico San Matteo di Pavia1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2024年6月18日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
14
试验地点
1
主要终点
Biventricular failure: left ventricular failure (LV EF <40%) and right ventricular failure (TAPSE <16% and/or FAC < 35% and/or S' wave velocity < 10 cm/sec) within 24 hours post transplantation

研究概览

简要总结

This is a single center retrospective/prospective observational study with additional procedures meant to evaluate molecular mechanisms underlying injury in donor's heart.

The research project will focus on Metabolomics by NMR and LC-MS and ultrastructural analysis using electron microscopy of endomyocardial biopsies (EMB).In our clinical protocol of heart transplantation, myocardial biopsy samples are routinely provided at intraoperative and postoperative time.

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Informed Consent available

排除标准

  • •Uncomplete donor data collection
  • •Patients undergoing heart-lung bloc transplantation.

结局指标

主要结局

Biventricular failure: left ventricular failure (LV EF <40%) and right ventricular failure (TAPSE <16% and/or FAC < 35% and/or S' wave velocity < 10 cm/sec) within 24 hours post transplantation

时间窗: Within 24 hours post transplantation

次要结局

  • ECMO within 24 hours of transplant for ventricular failure(Within 24 hours of transplant)
  • Death at 1, 6, 12 months after transplant (in absence of rejection(At 1, 6, 12 months after transplant)
  • Left ventricular failure (LV EF <40%) within 24 hours post transplantation(Within 24 hours post transplantation)
  • Left ventricular dysfunction (longitudinal global strain (LGS) < -14% at 1 month and <-17% at 6 and 12 months and/or FEvsx <50%) at 1, 6, 12 months after transplant (in absence of rejection)(At 1, 6, 12 months after transplant)
  • Right ventricular failure (TAPSE <16% and/or FAC < 35% and/or S' wave velocity < 10 cm/sec) within 24 hours post transplantation(Within 24 hours post transplantation)
  • Hemodynamic: Cardiac Index < 2 L/min/mq, wedge pressure >20 mmHg, right atrial pressure (RAP > 15 mmHg) within 24 hours post transplantation and at 1, 6, 12 months after transplant (in absence of rejection)(At 1, 6, 12 months after transplant)
  • Death for graft failure within 24 hours post transplantation(Within 24 hours post transplantation)
  • IABP within 24 hours of transplant for ventricular failure(Within 24 hours of transplant)
  • Echocardiographic parameters: E/A>>1; DT<150 msec; E/e'>15, atrial strain at 1, 6, 12 months after transplant (in absence of rejection)(At 1, 6, 12 months after transplant)
  • Trend of cardiac biomarker (BNP), trend of TNIhs, angiotensinogen, ADIPOQ, HGFAC, IGFBP3, other markers of ischaemia(At first and third week)

研究者

发起方
Fondazione IRCCS Policlinico San Matteo di Pavia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Stefano Pelenghi

Stefano Pelenghi

Fondazione IRCCS Policlinico San Matteo di Pavia

研究点 (1)

Loading locations...

相似试验