Strain Analysis as a Right Ventricle Contractility Marker

NCT03090204 | Completed

• 1 other identifier: 69HCL16-0370
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Systolic Function

Keywords

strain; myocarditic deformation imaging; right ventricle (RV); systolic RV function; preload dependence; contractility; intermittent hemodialysis (HDI)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Evaluation of the change in S' right ventricle wave

  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)

  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)

  at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution

• Evaluation of the change in mitral E wave

  at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution

• Evaluation of the change in mitral A wave

  at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution

Study Arms (1)

ultrasound measurements

OTHER

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

Interventions

ultrasound measurements PROCEDURE

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

ultrasound measurements

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female ≥ 18 years
• Patients with renal failure treated with intermittent hemodialysis

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (2)

Hôpital de la Croix Rousse

Lyon, 69004, France

Location

Hopital Saint Joseph Saint Luc

Lyon, 69007, France

Location

MeSH Terms

Conditions

Sprains and Strains

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Zoé Schmitt

  Hôpital de la Croix-Rousse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2017
• First Posted: March 24, 2017
• Study Start: November 25, 2016
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: October 31, 2019

Record last verified: 2019-10

Locations

FR (2)