Clinical trial NCT03090204: Strain Analysis as a Right Ventricle Contractility Marker
Official title: Strain Analysis as a Right Ventricle Contractility Marker
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Systolic Function
Keywords: strain
myocarditic deformation imaging
right ventricle (RV)
systolic RV function
preload dependence
contractility
intermittent hemodialysis (HDI)
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-03-24
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of the change in the Longitudinal strain of the free wall right ventricle
timeFrame: at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
Secondary outcomes:
measure: Evaluation of the change in S' right ventricle wave
timeFrame: at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
measure: Evaluation of the change in tricuspid annular plane systolic excursion (TAPSE)
timeFrame: at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
measure: Evaluation of the change in visual left ventricular ejection fraction (LVEF)
timeFrame: at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
measure: Evaluation of the change in mitral E wave
timeFrame: at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
measure: Evaluation of the change in mitral A wave
timeFrame: at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
measure: Evaluation of the change in wave E ' at the lateral mitral ring
timeFrame: at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
measure: Evaluation of the change in systolic fraction of pulmonary venous flow
timeFrame: at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
measure: inter individual variability of Longitudinal strain of the free wall right ventricle
timeFrame: at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
measure: intra individual variability of Longitudinal strain of the free wall right ventricle
timeFrame: at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital de la Croix Rousse
city: Lyon
country: France
facility: Hopital Saint Joseph Saint Luc
Study officials:
affiliation: Hôpital de la Croix-Rousse
name: Zoé Schmitt
role: PRINCIPAL_INVESTIGATOR
References: