Ventriculo-Arterial Coupling and Intra-Dialytic Changes in Hemodialysis Patients: Prognostic Insights

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

384 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-01

Study Completion Date

2026-11-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Right Ventricular Function in End-stage Renal Disease Patients

NCT04524468

Transthoracic Echocardiography Hemodialysis

COMPLETED

Changes in Cardiac Structure and Function After Establishment of Autologous Arteriovenous Fistula

NCT06199609

End Stage Renal Disease Arteriovenous Fistula

COMPLETED

Hemodialysis-Induced Renal Perfusion Decline: Unraveling the Pathophysiological Mechanisms Linking Intradialytic Circulatory Stress to Residual Renal Function Loss

NCT07003828

End-Stage Renal Disease Requiring Haemodialysis

ACTIVE_NOT_RECRUITING

Coronary Revascularization in Patients On Dialysis in China-Retrospective Registry

NCT05841082

Coronary Artery Disease End Stage Renal Disease Dialysis

UNKNOWN

Study of Diastolic Dysfunction in ESKD in Hemodialysis Patient

NCT07180888

Heart Failure ESKD Hemodialysis Patients

NOT_YET_RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hemodialysis Ventriculo-arterial Coupling

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

End-Stage Renal Disease Patients on Hemodialysis

Patients with end-stage renal disease (ESRD) undergoing regular hemodialysis, recruited based on specific inclusion and exclusion criteria. Inclusion criteria include patients aged 18 or older, receiving a standard renal replacement therapy of three dialysis sessions per week, with a dialysis history of at least 3 months and dialysis adequacy (Kt/V \>1.2). Exclusion criteria include patients with a history of kidney transplantation, recent myocardial infarction or stroke, severe heart failure, chronic atrial fibrillation, obesity (BMI \>40 kg/m²), and malignancy.

Patients will undergo echocardiographic evaluations before and after dialysis, with a focus on left ventricular function and ventriculo-arterial coupling (VAC) using speckle-tracking echocardiography and pressure-volume loop analysis.

Echocardiogram

Intervention Type DIAGNOSTIC_TEST

Echocardiographic Assessments:

Pre-Hemodialysis Echocardiography:

Before each hemodialysis session, echocardiograms will be performed to evaluate cardiac function and gather baseline data on ventriculo-arterial coupling (VAC) parameters. This will include recording three apical echocardiographic views (4-chamber, 2-chamber, and 3-chamber) by a trained sonographer.

Post-Hemodialysis Echocardiography:

Following the completion of the hemodialysis session, echocardiographic assessments will be repeated to measure changes in VAC parameters and other relevant cardiac metrics.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Echocardiogram

Echocardiographic Assessments:

Pre-Hemodialysis Echocardiography:

Before each hemodialysis session, echocardiograms will be performed to evaluate cardiac function and gather baseline data on ventriculo-arterial coupling (VAC) parameters. This will include recording three apical echocardiographic views (4-chamber, 2-chamber, and 3-chamber) by a trained sonographer.

Post-Hemodialysis Echocardiography:

Following the completion of the hemodialysis session, echocardiographic assessments will be repeated to measure changes in VAC parameters and other relevant cardiac metrics.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No