Intradialytic Changes and Prognostic Value of Ventriculo-Arterial Coupling in Patients With End-Stage Renal Disease: Protocol for an Observational Prospective Trial.

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 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.

OBJECTIVE

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.

METHODS

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.

RESULTS

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.

CONCLUSIONS

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.

TRIAL REGISTRATION: ClinicalTrials.gov NCT06622928; https://clinicaltrials.gov/study/NCT06622928.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/71948.