Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06622928
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-29
Brief Title:
Ventriculo-Arterial Coupling and Intra-Dialytic Changes in Hemodialysis Patients Prognostic Insights
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Ventriculo-arterial Coupling in Patients With End-stage Renal Disease on Hemodyalisis Intra-dialytic Changes and Prognostic Value
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 pressurevolume 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 lt005
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 pressurevolume 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 lt005
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None