Salustri Alessandro, Tonti Giovanni, Pedrizzetti Gianni, Zhankorazova Aizhan, Khamitova Zaukiya, Toktarbay Bauyrzhan, Jumadilova Dinara, Khvan Marina, Galiyeva Dinara, Bekbossynova Makhabbat, Mukarov Murat, Kokoshko Alexey, Gaipov Abduzhappar
Nazarbayev University School of Medicine, Astana, Kazakhstan.
University of Chieti-Pescara, Chieti, Italy.
JMIR Res Protoc. 2025 Jun 23;14:e71948. doi: 10.2196/71948.
The acute effect of hemodialysis (HD) on left ventricular mechanics has been evaluated in several studies; however, their results are not consistent. 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 cardiovascular function and cardiac energetics. However, there have not been any studies demonstrating changes in terms of volumes, contractility, intraventricular pressure gradient distribution, and vascular properties in response to changes in loading conditions and their impact on the outcome in patients undergoing HD. Recently, a noninvasive method for assessing left ventricular pressure-volume loop and ventriculo-arterial coupling (VAC) from feature-tracking cardiac magnetic resonance or echocardiography has been proposed. We believe that this method allows a comprehensive evaluation of the hemodynamic status of the patients undergoing HD, including the relationships between cardiac function and arterial elastance, and might provide prognostic information.
The primary objective of this study is to evaluate changes in VAC before and after a HD session. The secondary objective is to assess the prognostic value of VAC parameters in predicting adverse outcomes.
A 2D transthoracic echocardiogram will be performed before and after a HD session in patients with end-stage renal disease. We target to enroll 323 patients. Images will be analyzed with advanced software based on speckle-tracking, able to reconstruct the pressure-volume loop. From the pressure-volume loop, arterial (Ea) and ventricular (Ees) elastance will be derived. VAC will be calculated as the Ea/Ees ratio. Patients will be followed up for 18 months. Primary endpoints will be a composite of all causes of death, nonfatal myocardial infarction, and hospitalization due to worsening heart failure.
The study received funding in August 2024, with patients' enrollment scheduled to take place from January 1 to June 30, 2025. Data analysis will start in April 2025 and is expected to continue until June 2026. The findings of the study are tentatively planned for publication in the winter of 2027.
This study will provide data on the changes in VAC induced by HD and their potential prognostic value. This assessment could be useful for tailoring volume depletion during HD and to improve patients' outcomes.
ClinicalTrials.gov NCT06622928; https://clinicaltrials.gov/study/NCT06622928.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/71948.
多项研究评估了血液透析（HD）对左心室力学的急性影响；然而，其结果并不一致。最终，心脏和动脉系统是一个相互关联的系统，而非孤立的结构；因此，评估心脏收缩力与动脉系统的相互作用将能更全面地理解心血管功能和心脏能量学。然而，尚无研究表明在接受HD的患者中，负荷条件变化时，心室容积、收缩力、心室内压力梯度分布和血管特性的变化及其对预后的影响。最近，有人提出了一种通过特征跟踪心脏磁共振成像或超声心动图评估左心室压力-容积环和心室-动脉耦合（VAC）的非侵入性方法。我们认为这种方法可以全面评估接受HD患者的血流动力学状态，包括心脏功能与动脉弹性之间的关系，并可能提供预后信息。
本研究的主要目的是评估HD治疗前后VAC的变化。次要目的是评估VAC参数在预测不良结局方面的预后价值。
将对终末期肾病患者在HD治疗前后进行二维经胸超声心动图检查。我们的目标是招募323名患者。将使用基于斑点跟踪的先进软件分析图像，该软件能够重建压力-容积环。从压力-容积环中，可得出动脉弹性（Ea）和心室弹性（Ees）。VAC将计算为Ea/Ees比值。患者将接受18个月的随访。主要终点将是全因死亡、非致命性心肌梗死以及因心力衰竭恶化住院的综合情况。
该研究于2024年8月获得资金，计划于2025年1月1日至6月30日招募患者。数据分析将于2025年4月开始，预计持续至2026年6月。该研究结果暂计划于2027年冬季发表。
本研究将提供HD引起的VAC变化及其潜在预后价值的数据。这种评估可能有助于在HD期间调整容量清除并改善患者预后。
ClinicalTrials.gov NCT06622928；https://clinicaltrials.gov/study/NCT06622928。
国际注册报告识别码（IRRID）：PRR1-10.2196/71948。
