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Strain Analysis as a Right Ventricle Contractility Marker

Strain Analysis as a Right Ventricle Contractility Marker

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03090204
Enrollment
16
Registered
2017-03-24
Start date
2016-11-25
Completion date
2017-12-31
Last updated
2019-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systolic Function

Keywords

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

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.

Interventions

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

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of the change in the Longitudinal strain of the free wall right ventricleat baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitutionmeasurements 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

Secondary

MeasureTime frameDescription
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 restitutionmeasurements 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
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 restitutionmeasurements 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
Evaluation of the change in mitral E waveat baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitutionmeasurements 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
Evaluation of the change in mitral A waveat baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitutionmeasurements 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
Evaluation of the change in S' right ventricle waveat baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitutionmeasurements 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
Evaluation of the change in systolic fraction of pulmonary venous flowat baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitutionmeasurements 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
inter individual variability of Longitudinal strain of the free wall right ventricleat baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitutionEach measurement will be performed by two blind operators
intra individual variability of Longitudinal strain of the free wall right ventricleat baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitutionEach measurement will be performed by two blind operators
Evaluation of the change in wave E ' at the lateral mitral ringat baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitutionmeasurements 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026