Systolic FunctionNCT03090204
Strain Analysis as a Right Ventricle Contractility Marker
A study testing ultrasound measurements in people with Systolic Function, run by Hospices Civils de Lyon at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systolic Function
- What is being tested?
- ultrasound measurements
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesFrance
- Study dates
- 25 Nov 2016to 31 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital de la Croix Rousse
Lyon, 69004
Hopital Saint Joseph Saint Luc
Lyon, 69007
About this study
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
- Being tested
- ultrasound measurements
- Keywords
- strain, myocarditic deformation imaging, right ventricle (RV), systolic RV function, preload dependence, contractility, intermittent hemodialysis (HDI)
- Medical subject headings
- Sprains and Strains
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound measurementsProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: ultrasound measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2017
- Study start25 Nov 2016
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systolic FunctionStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zoé Schmitt, Principal investigator, Hôpital de la Croix-Rousse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03090204
- Sponsor's protocol ID
- 69HCL16-0370
- Status last verified
- Oct 2019
- First submitted
- 10 Mar 2017
- Last updated
- 31 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strain Analysis as a Right Ventricle Contractility Marker
- ClinicalTrials.gov ID
- NCT03090204
- Acronym / sponsor ID
- 69HCL16-0370
- Conditions
- Systolic Function
- Keywords
- strain, myocarditic deformation imaging, right ventricle (RV), systolic RV function, preload dependence, contractility, intermittent hemodialysis (HDI)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 25 Nov 2016 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 24 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ultrasound measurements | Other | Procedure: ultrasound measurementsultrasound measurements of myocardial deformation of free wall right ventricle during a sharp decline of right ventricle preload induced during a session of Intermittent hemodialysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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:
- Patients not willing to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasound measurementsultrasound 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 | Procedure or surgery | ultrasound measurements |
Primary outcome
Evaluation of the change in the Longitudinal strain of the free wall right ventricle
Time frame: at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
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
9 secondary outcomes
Evaluation of the change in S' right ventricle wave
Time frame: 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)
Time frame: 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)
Time frame: at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
Evaluation of the change in mitral E wave
Time frame: at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
Evaluation of the change in mitral A wave
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zoé Schmitt principal investigator
Hôpital de la Croix-Rousse
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound measurements in people with Systolic Function, run by Hospices Civils de Lyon at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the change in the Longitudinal strain of the free wall right ventricle (time frame: at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2019.