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临床试验/NCT06622928
NCT06622928尚未招募不适用

Ventriculo-arterial Coupling in Patients With End-stage Renal Disease on Hemodyalisis: Intra-dialytic Changes and Prognostic Value.

Nazarbayev University1 个研究点 分布在 1 个国家目标入组 384 人开始时间: 2024年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
384
试验地点
1
主要终点
Evaluation of Interdialytic Changes in Ventricular-Arterial Coupling (VAC) and Its Prognostic Value in Patients Undergoing Regular Hemodialysis

研究概览

简要总结

The acute effect of hemodialysis (HD) on left ventricular mechanics has been evaluated in several studies, however their results are not uniform. Eventually, the heart and the arterial system behave as an interconnected system and not as isolated structures; thus, the evaluation of the interaction of cardiac contractility with the arterial system would provide a more comprehensive understanding of the cardiovascular function and cardiac energetics. However, there have not been any studies demonstrating changes in terms of volumes, contractility, intraventricular pressure gradients distribution, and vascular properties in response to changes in loading conditions and their impact on the outcome.

With these concepts in mind, we aim to evaluate the effect of volume changes induced by HD on ventriculo-arterial coupling (VAC) computed from speckle-tracking echocardiography. In particular, we seek to study patients with end-stage renal disease (ESRD) to assess:

  1. VAC parameters before and after the hemodialysis session;
  2. The value of VAC parameters in predicting adverse outcome

Three-hundred-eighty-four patients with ESRD will be evaluated by standard 2-D echocardiography before and after the HD session. Echocardiographic speckle tracking images will be analysed off-line using a dedicated software based on a mathematical model (QStrain, Medis BV, Leiden, NL). The software reconstructs the pressure/volume (PV) loop by determining the end-systolic and end-diastolic pressure-volume relationship using the single-beat algorithms. The PV relation will be depicted for the entire cardiac cycle where each point of the curve is described as (Vt, Pt). Based on this integrated PV loop analysis, the following hemodynamic parameters will be calculated: LV systolic elastance (Ees); Arterial elastance (Ea); Ventricular-Arterial Coupling (VAC); Stroke Work (SW); Pressure-volume area (PVA); Work efficiency (WE).

Patients will be followed-up for 18 months. Primary end-point will be a composite of all-cause of death, nonfatal myocardial infarction, and hospitalization due to worsening heart failure. Secondary end-point will be a composite of cardiac death, nonfatal myocardial infarction, and hospitalization for heart failure. Event-free survival for each of the echocardiographic and VAC parameters will be assessed using Kaplan-Meier analysis and compared with a log-rank test, where each index will be dichotomized according to the median of its distribution. The prognostic value will be determined using the Cox proportional hazards model. Differences will be considered statistically significant when p <0.05.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years or older;
  • Standard renal replacement schedule with 3 dialysis sessions per week;
  • Dialysis vintage of at least 3 months;
  • Dialysis adequacy with single-pool Kt/V >1.2

排除标准

  • Previous kidney transplantation
  • Myocardial infarction, unstable angina or stroke during the previous 6 months;
  • Severe stage III to IV congestive heart failure according to the NYHA classification;
  • Chronic atrial fibrillation or other known arrhythmia;
  • History of non-adherence to the prescribed weekly dialysis schedule in the previous month;
  • Body mass index >40 Kg/m2; or
  • History of malignancy or other clinical conditions associated with very poor prognosis.

结局指标

主要结局

Evaluation of Interdialytic Changes in Ventricular-Arterial Coupling (VAC) and Its Prognostic Value in Patients Undergoing Regular Hemodialysis

时间窗: 1 year

次要结局

未报告次要终点

研究者

发起方
Nazarbayev University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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