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LVAD Index and Clinical Outcomes in Continuous-Flow LVAD Patients (LVAD-INDEX)

2026年6月2日 更新者：Gaziantep City Hospital

Association of LVAD Index With Selected Hepatic and Renal Biochemical Markers and Rehospitalization in HVAD and HeartMate 3 Continuous-Flow Left Ventricular Assist Devices

This single-center, observational study evaluated the LVAD index, defined as device-estimated pump flow divided by body surface area, in adult patients supported with continuous-flow left ventricular assist devices. The study included 34 patients with end-stage heart failure who had either an HVAD or HeartMate 3 device and were followed for six months. The study assessed the relationship between LVAD index and selected routine biochemical markers related to hepatic and renal status, including ALT, AST, LDH, BUN, and creatinine. The study also evaluated whether LVAD index was associated with rehospitalization during follow-up.

研究概览

地位

完全的

条件

干预/治疗

详细说明

This observational cohort study included adult patients with end-stage heart failure supported with continuous-flow left ventricular assist devices. Patients with HVAD and HeartMate 3 devices were followed during routine clinical visits over a six-month period. Device-estimated pump flow, power consumption, and LVAD index were recorded at follow-up visits. LVAD index was calculated as device-estimated pump flow divided by body surface area. Routine laboratory parameters, including ALT, AST, LDH, BUN, and creatinine, were evaluated as selected biochemical markers related to hepatic and renal status and tissue injury. Rehospitalization status during follow-up was also assessed. The study did not assign participants to any intervention and did not include protocol-driven pump speed adjustment.

研究类型

观察性的

注册 (实际的)

34

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

Adult patients with end-stage heart failure who underwent first-time continuous-flow left ventricular assist device implantation and were followed for at least six months. The study population included patients supported with either HVAD or HeartMate 3 devices during routine clinical follow-up.

描述

Inclusion Criteria:

  • Age 18 years or older
  • Diagnosis of end-stage heart failure
  • First-time continuous-flow left ventricular assist device implantation
  • Implanted with either an HVAD or HeartMate 3 left ventricular assist device
  • Minimum follow-up period of six months

Exclusion Criteria:

  • Incomplete data
  • Declined participation
  • HeartMate II pump implantation
  • Significant aortic valve dysfunction, including moderate or severe aortic regurgitation or stenosis

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
HVAD Group
Patients supported with the HeartWare Ventricular Assist Device.
设备：HeartWare Ventricular Assist Device
Patients in this group were supported with the HeartWare Ventricular Assist Device as part of routine clinical care. No device assignment or protocol-driven intervention was performed by the study investigators.
HeartMate 3 Group
Patients supported with the HeartMate 3 left ventricular assist device.
设备：HeartMate 3 Left Ventricular Assist Device
Patients in this group were supported with the HeartMate 3 left ventricular assist device as part of routine clinical care. No device assignment or protocol-driven intervention was performed by the study investigators.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Association Between LVAD Index and Selected Biochemical Markers
大体时间：Six months
The association between LVAD index and selected routine biochemical markers, including ALT, AST, LDH, BUN, and creatinine, was evaluated during six-month follow-up. LVAD index was calculated as device-estimated pump flow divided by body surface area.
Six months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Gaziantep City Hospital

合作者

Akdeniz University Hospital
Antalya City Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2022年10月1日

初级完成 (实际的)

2023年4月30日

研究完成 (实际的)

2023年4月30日

研究注册日期

首次提交

2026年6月2日

首先提交符合 QC 标准的

2026年6月2日

首次发布 (实际的)

2026年6月8日

研究记录更新

最后更新发布 (实际的)

2026年6月8日

上次提交的符合 QC 标准的更新

2026年6月2日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • LVADIDX2022

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

Individual participant data will not be publicly shared due to patient confidentiality and institutional data protection requirements. De-identified data may be made available from the corresponding author upon reasonable request.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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