Strain Analysis as a Right Ventricle Contractility Marker

The analysis of the systolic function (contractility) of the right ventricle (RV) is fundamental and central in many pathologies in intensive care unit. It can guide physicians in choosing therapeutics. The conventional ultrasound markers of RV function evaluation currently used are influenced by RV loading conditions, impairing their capacity to approximate a true contractility analysis. Myocardial strain imaging is a recent echographic technique that allows, among other things, to evaluate RV systolic function. It is a reproducible index with early variations which, if it proved to be independent pre-load, would help to better appreciate the RV contractility.

Study Overview

• Status: Completed
• Conditions: Systolic Function
• Intervention / Treatment: Procedure: ultrasound measurements

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69004
    • Hôpital de la Croix Rousse
  • Lyon, France, 69007
    • Hopital Saint Joseph Saint Luc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female ≥ 18 years
• Patients with renal failure treated with intermittent hemodialysis
• Patients who received an information and did not opposed to participate in the study, or, if unconscious patient at the time of inclusion: a person of trust as defined in Article L. 1111-6 of the Public Health Code, failing that, the family or, failing that, a person maintaining stable link, having received information and not opposed to participate in the study.

Exclusion Criteria:

• Patients with heart disease (valvular, ischemic, rhythmic)
• Patients with ejection fraction of left ventricular altered <45%
• Chronic dialysis patients

• Patients referred in Articles L. 1121-5, L.1121-6, L.1121-7, L.1121-8 of the Public Health Code:

  • Pregnant women, parturients or nursing mothers
  • Persons deprived of their liberty by a judicial or administrative decision, persons subject to psychiatric care, persons admitted to a health or social institution for purposes other than research
  • Minor Patients
  • Major persons who are subject to a legal protection measure or are unable to express their consent
• Patients not willing to participate in the study
• Patients not affiliated to a social security

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: ultrasound measurements; ultrasound measurements of myocardial deformation of free wall right ventricle during a sharp decline of right ventricle preload induced during a session of Intermittent hemodialysis.	Procedure: ultrasound measurements; ultrasound measurements of myocardial deformation of free wall right ventricle at 4 time points during a session of intermittent hemodialysis : before the intermittent hemodialysis connection, just after starting hemodialysis, after 1 hour of hemodialysis and 5 minutes before restitution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the change in the Longitudinal strain of the free wall right ventricle	measurements will be performed using an ultrasound device usually used in our center for the hemodynamic monitoring of patients in intensive care by transthoracic cardiac ultrasound	at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the change in S' right ventricle wave	measurements will be performed using an ultrasound device usually used in our center for the hemodynamic monitoring of patients in intensive care by transthoracic cardiac ultrasound	at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
Evaluation of the change in tricuspid annular plane systolic excursion (TAPSE)	measurements will be performed using an ultrasound device usually used in our center for the hemodynamic monitoring of patients in intensive care by transthoracic cardiac ultrasound	at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
Evaluation of the change in visual left ventricular ejection fraction (LVEF)	measurements will be performed using an ultrasound device usually used in our center for the hemodynamic monitoring of patients in intensive care by transthoracic cardiac ultrasound	at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
Evaluation of the change in mitral E wave	measurements will be performed using an ultrasound device usually used in our center for the hemodynamic monitoring of patients in intensive care by transthoracic cardiac ultrasound	at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
Evaluation of the change in mitral A wave	measurements will be performed using an ultrasound device usually used in our center for the hemodynamic monitoring of patients in intensive care by transthoracic cardiac ultrasound	at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
Evaluation of the change in wave E ' at the lateral mitral ring	measurements will be performed using an ultrasound device usually used in our center for the hemodynamic monitoring of patients in intensive care by transthoracic cardiac ultrasound	at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
Evaluation of the change in systolic fraction of pulmonary venous flow	measurements will be performed using an ultrasound device usually used in our center for the hemodynamic monitoring of patients in intensive care by transthoracic cardiac ultrasound	at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
inter individual variability of Longitudinal strain of the free wall right ventricle	Each measurement will be performed by two blind operators	at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
intra individual variability of Longitudinal strain of the free wall right ventricle	Each measurement will be performed by two blind operators	at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Zoé Schmitt, Hopital De La Croix-Rousse

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2016
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: March 10, 2017
• First Submitted That Met QC Criteria: March 20, 2017
• First Posted (Actual): March 24, 2017

Study Record Updates

• Last Update Posted (Actual): October 31, 2019
• Last Update Submitted That Met QC Criteria: October 30, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: strain; myocarditic deformation imaging; right ventricle (RV); systolic RV function; preload dependence; contractility; intermittent hemodialysis (HDI)
• Additional Relevant MeSH Terms: Heart Murmurs; Systolic Murmurs
• Other Study ID Numbers: 69HCL16-0370

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No