Accepted for/Published in: JMIR Research Protocols
Date Submitted: Feb 1, 2025
Date Accepted: Mar 30, 2025
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Intra-dialytic changes and prognostic value of ventriculo-arterial coupling in patients with end-stage renal disease: study protocol for an observational, prospective trial
ABSTRACT
Background:
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 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 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.
Objective:
The primary objective is to evaluate changes in VAC before and after a hemodialysis session. The secondary objective is to assess the prognostic value of VAC parameters in predicting adverse outcomes, including all-cause mortality, nonfatal myocardial infarction, and hospitalization due to worsening heart failure, in patients with end-stage renal disease.
Methods:
Two-dimensional transthoracic echocardiogram will be performed before and after a HD session in 384 patients with end-stage renal disease. Images will be analyzed with an 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. Ventriculo-arterial coupling will be calculated as Ea/Ees ratio. 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.
Results:
The study received funding in August, 2024, with data collection scheduled to take place from January 1 to June 30, 2025. Data analysis is set to commence 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.
Conclusions:
This study will provide data on the changes in VAC induced by HD. This assessment could be useful for tailoring the volume depletion during HD and to improve patients’ outcome. Clinical Trial: ClinicalTrials.gov Identifier: NCT06622928 – Registered 2 October 2024 https://clinicaltrials.gov/study/NCT06622928?id=NCT06622928&rank=1
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