Observational Study With Additional Procedures: Metabolomic and Ultrastructural Findings of Allograft in Heart Transplantation and Their Correlation With Graft Dysfunction.
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
Stefano Pelenghi
Stefano Pelenghi
Fondazione IRCCS Policlinico San Matteo di Pavia
