Coronary SurgeryNCT03922178
Evaluation of Hemodynamic Changes of the Left Ventricle Following the Use of Extracorporeal Circulation
A study testing Pressure/Volume Combination Catheter, Transthoracic echocardiography and Transesophageal echocardiogram in people with Coronary Surgery, run by Pierre Wauthy at 1 site in Belgium.
Trial summary
The interpretation of perioperative measures of cardiac function during cardiac surgery is complicated. In particular, the evaluation of the diastolic compliance of the left ventricle. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Surgery
- What is being tested?
- Pressure/Volume Combination Catheter, Transthoracic echocardiography and Transesophageal echocardiogram
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteBelgium
- Study dates
- 13 Nov 2018to 16 Jan 2020
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient of the CHU Brugmann Hospital receiving elective coronary surgery.
- Patient in sinusal rhythm before the operation and during the collection of hemodynamic data.
- Patients with conserved left ventricular function (based on left ventricular ejection fraction assessed by preoperative echocardiography and superior to 50%)
Who cannot join
- Hypertrophic cardiomyopathy (diastolic septal thickness> 15 mm)
- Heart failure with left ventricular ejection fraction <50%
- Presence of cardiac valvulopathy, concerning both right and left atrio-ventricular and ventriculo-arterial valves
- Presence of valvular prosthesis
- Congenital heart disease
- Pregnancy
- Participation to another clinical study
Trial locations and contacts
1 site in 1 country.
About this study
The interpretation of perioperative measures of cardiac function during cardiac surgery is complicated. In particular, the evaluation of the diastolic compliance of the left ventricle. In addition, they are subject to variations induced by post-charge changes caused by the anesthesia, extracorporeal circulation (ECC) and the surgical procedure itself.
Left ventricular failure is frequently measured by alteration of LV contractile properties, and very rarely by alteration of LV compliance. However, both contractility (systolic) and relaxation (diastolic) parameters are important for the left ventricle to perform its function adequately. Left ventricular failure after cardiac surgery with extracorporeal circulation and cardiac arrest under cardioplegia protection is an important and frequently reported complication. The investigator's objectives are to characterize the diastolic hemodynamic mechanisms of this left ventricular failure and to identify predictors of this failure in the postoperative period.
Read more
The quantification of the systolic and diastolic functions of the left ventricle by ventricular pressure-volume curves is the technique of reference today, because it allows to determine parameters that are independent of the pre- and post-load conditions. Previous studies using the conductance catheter for the purpose of estimating left ventricular function perioperatively are rare and report conflicting results. In addition, they were mainly intended to measure the systolic function of the left ventricle. Only one reported the diastolic relaxation parameters evaluated by a conductance catheter. This study showed immediately after withdrawal of the extracorporeal circulation a significant alteration of the diastolic relaxation of the left ventricle, but was not interested in its early (kinetic) evolution peroperatively.
The investigator's experience shows that, in the quarter-hour following the weaning of the extracorporeal circulation, a decrease in filling pressures of the left ventricle concomitant with an increase in cardiac output is objectified. These observations are consistent with a significant improvement in left ventricle compliance, but have never been reported.
The objectives of this study are:
- To characterize the left ventricular diastolic failure after withdrawal of the extracorporeal circulation in coronary surgery.
- To identify the kinetics of this early diastolic failure after withdrawal of the extracorporeal circulation.
- Conditions
- Coronary Surgery
- Being tested
- Pressure/Volume Combination Catheter, Transthoracic echocardiography, Transesophageal echocardiogram
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pressure/Volume Combination CatheterDevice
Hemodynamic data routinely collected and data collected by means of the placement of a Pressure/Volume Combination Catheter (Pressure/Volume Combination Catheter,Leycom,The Netherlands) will be collected simultaneously. The catheter will be placed and held in place as long as the patient is in a position to be assisted by extracorporeal circulation. This means that the placement of the catheter will follow the heparinization of the patient and the placement of the cannulas necessary for the realization of extracorporal circulation. It will be removed from the left ventricular cavity before removal of extra-corporal cannulas.
Transthoracic echocardiographyDevice
A complete transthoracic echocardiography will be performed the day before the surgical procedure, as per standard of care. It will establish the presence of the inclusion and exclusion criteria and evaluate the contractile function of the left ventricle. This will be done using a Philips IE33 echocardiograph (Koninklijke Philips Electronics N.V., Netherlands).
Transesophageal echocardiogramDevice
A transesophageal echocardiogram will be performed during the cardiac surgery, as per standard of care, using an Acuson Sequoia system (Siemens AG, Germany). It will facilitate the placement of the pressure/volume combination catheter and collect echographic data.
| Study group | Role | What they receive |
|---|---|---|
| Elective coronary surgery | Experimental | The study will be conducted at the CHU Brugmann Hospital, with collaboration between cardiac surgery and anesthesiology wards. Subjects referred for elective coronary surgery will be prospectively included during the length of the study. Receives: Device: Pressure/Volume Combination Catheter; Device: Transthoracic echocardiography; Device: Transesophageal echocardiogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tele-systolic pressure of the left ventricle
Pressure within the left ventricle after the atrial contraction, at the beginning of the ventricular contraction.
Measured: Baseline (before extracorporeal circulation is switched on)
Tele-systolic pressure of the left ventricle
Pressure within the left ventricle after the atrial contraction, at the beginning of the ventricular contraction.
Measured: 1 minute after extracorporeal circulation is switched on
Tele-systolic pressure of the left ventricle
Pressure within the left ventricle after the atrial contraction, at the beginning of the ventricular contraction.
Measured: 1 minute after extracorporeal circulation is stopped
Tele-systolic pressure of the left ventricle
Pressure within the left ventricle after the atrial contraction, at the beginning of the ventricular contraction.
Measured: 10 minutes after extracorporeal circulation is stopped
Tele-systolic pressure of the left ventricle
Pressure within the left ventricle after the atrial contraction, at the beginning of the ventricular contraction.
Measured: 20 minutes after extracorporeal circulation is stopped
Diastolic pressure of the left ventricle
The pressure within the left ventricle following the completion of diastolic filling, just prior to systole.
Measured: Baseline (before extracorporeal circulation is switched on)
Diastolic pressure of the left ventricle
The pressure within the left ventricle following the completion of diastolic filling, just prior to systole.
Measured: 1 minute after extracorporeal circulation is switched on
Diastolic pressure of the left ventricle
The pressure within the left ventricle following the completion of diastolic filling, just prior to systole.
Measured: 1 minute after extracorporeal circulation is stopped
Diastolic pressure of the left ventricle
The pressure within the left ventricle following the completion of diastolic filling, just prior to systole.
Measured: 10 minutes after extracorporeal circulation is stopped
Diastolic pressure of the left ventricle
The pressure within the left ventricle following the completion of diastolic filling, just prior to systole.
Measured: 20 minutes after extracorporeal circulation is stopped
Tele-systolic volume of the left ventricle
At the end of systole, the ventricle contains a quantity of blood called 'telesystolic volume'.
Measured: Baseline
Tele-systolic volume of the left ventricle
At the end of systole, the ventricle contains a quantity of blood called 'telesystolic volume'.
Measured: 1 minute after extracorporeal circulation is switched on
Tele-systolic volume of the left ventricle
At the end of systole, the ventricle contains a quantity of blood called 'telesystolic volume'.
Measured: 1 minute after extracorporeal circulation is stopped
Tele-systolic volume of the left ventricle
At the end of systole, the ventricle contains a quantity of blood called 'telesystolic volume'.
Measured: 10 minutes after extracorporeal circulation is stopped
Tele-systolic volume of the left ventricle
At the end of systole, the ventricle contains a quantity of blood called 'telesystolic volume'.
Measured: 20 minutes after extracorporeal circulation is stopped
Diastolic volume of the left ventricle
At the end of diastole, the ventricle contains a quantity of blood called end-diastolic volume.
Measured: Baseline
Diastolic volume of the left ventricle
At the end of diastole, the ventricle contains a quantity of blood called end-diastolic volume.
Measured: 1 minute after extracorporeal circulation is switched on
Diastolic volume of the left ventricle
At the end of diastole, the ventricle contains a quantity of blood called end-diastolic volume.
Measured: 1 minute after extracorporeal circulation is stopped
Diastolic volume of the left ventricle
At the end of diastole, the ventricle contains a quantity of blood called end-diastolic volume.
Measured: 10 minutes after extracorporeal circulation is stopped
Diastolic volume of the left ventricle
At the end of diastole, the ventricle contains a quantity of blood called end-diastolic volume.
Measured: 20 minutes after extracorporeal circulation is stopped
Ejection volume of the left ventricle
The ejection volume is the difference between systolic and diastolic volume. It represents the amount of blood ejected at each contraction by the ventricle.
Measured: Baseline
Ejection volume of the left ventricle
The ejection volume is the difference between systolic and diastolic volume. It represents the amount of blood ejected at each contraction by the ventricle.
Measured: 1 minute after extracorporeal circulation is switched on
Ejection volume of the left ventricle
The ejection volume is the difference between systolic and diastolic volume. It represents the amount of blood ejected at each contraction by the ventricle.
Measured: 1 minute after extracorporeal circulation is stopped
Ejection volume of the left ventricle
The ejection volume is the difference between systolic and diastolic volume. It represents the amount of blood ejected at each contraction by the ventricle.
Measured: 10 minutes after extracorporeal circulation is stopped
Ejection volume of the left ventricle
The ejection volume is the difference between systolic and diastolic volume. It represents the amount of blood ejected at each contraction by the ventricle.
Measured: 20 minutes after extracorporeal circulation is stopped
Contractility index of the left ventricle
Computed by the following formula: (dP/dt max)/P
Measured: Baseline
Contractility index of the left ventricle
Computed by the following formula: (dP/dt max)/P
Measured: 1 minute after extracorporeal circulation is switched on
Contractility index of the left ventricle
Computed by the following formula: (dP/dt max)/P
Measured: 1 minute after extracorporeal circulation is stopped
Contractility index of the left ventricle
Computed by the following formula: (dP/dt max)/P
Measured: 10 minutes after extracorporeal circulation is stopped
Contractility index of the left ventricle
Computed by the following formula: (dP/dt max)/P
Measured: 20 minutes after extracorporeal circulation is stopped
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2019
- Study start13 Nov 2018
- Primary completion16 Jan 2020
- Study completion16 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary SurgeryStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Wauthy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pierre Wauthy, Brugmann University Hospital
- Investigators
- Charlotte Leclercq, MD, Principal investigator, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03922178
- Sponsor's protocol ID
- CHUB-Leclercq
- Status last verified
- Jan 2020
- First submitted
- 17 Apr 2019
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Hemodynamic Changes of the Left Ventricle Following the Use of Extracorporeal Circulation
- ClinicalTrials.gov ID
- NCT03922178
- Acronym / sponsor ID
- CHUB-Leclercq
- Conditions
- Coronary Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Pierre WauthyUniversity, hospital or other
- Study start
- 13 Nov 2018 (actual)
- Primary completion
- 16 Jan 2020 (actual)
- Study completion
- 16 Jan 2020 (actual)
- First posted
- 19 Apr 2019 (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 interpretation of perioperative measures of cardiac function during cardiac surgery is complicated. In particular, the evaluation of the diastolic compliance of the left ventricle. In addition, they are subject to variations induced by post-charge changes caused by the anesthesia, extracorporeal circulation (ECC) and the surgical procedure itself.
Left ventricular failure is frequently measured by alteration of LV contractile properties, and very rarely by alteration of LV compliance. However, both contractility (systolic) and relaxation (diastolic) parameters are important for the left ventricle to perform its function adequately. Left ventricular failure after cardiac surgery with extracorporeal circulation and cardiac arrest under cardioplegia protection is an important and frequently reported complication. The investigator's objectives are to characterize the diastolic hemodynamic mechanisms of this left ventricular failure and to identify predictors of this failure in the postoperative period.
The quantification of the systolic and diastolic functions of the left ventricle by ventricular pressure-volume curves is the technique of reference today, because it allows to determine parameters that are independent of the pre- and post-load conditions. Previous studies using the conductance catheter for the purpose of estimating left ventricular function perioperatively are rare and report conflicting results. In addition, they were mainly intended to measure the systolic function of the left ventricle. Only one reported the diastolic relaxation parameters evaluated by a conductance catheter. This study showed immediately after withdrawal of the extracorporeal circulation a significant alteration of the diastolic relaxation of the left ventricle, but was not interested in its early (kinetic) evolution peroperatively.
The investigator's experience shows that, in the quarter-hour following the weaning of the extracorporeal circulation, a decrease in filling pressures of the left ventricle concomitant with an increase in cardiac output is objectified. These observations are consistent with a significant improvement in left ventricle compliance, but have never been reported.
The objectives of this study are:
- To characterize the left ventricular diastolic failure after withdrawal of the extracorporeal circulation in coronary surgery.
- To identify the kinetics of this early diastolic failure after withdrawal of the extracorporeal circulation.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elective coronary surgery | Experimental | Device: Pressure/Volume Combination Catheter, Device: Transthoracic echocardiography, Device: Transesophageal echocardiogramThe study will be conducted at the CHU Brugmann Hospital, with collaboration between cardiac surgery and anesthesiology wards. Subjects referred for elective coronary surgery will be prospectively included during the length of the study. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient of the CHU Brugmann Hospital receiving elective coronary surgery.
- Patient in sinusal rhythm before the operation and during the collection of hemodynamic data.
- Patients with conserved left ventricular function (based on left ventricular ejection fraction assessed by preoperative echocardiography and superior to 50%)
Key exclusion criteria (7 listed)
- Hypertrophic cardiomyopathy (diastolic septal thickness> 15 mm)
- Heart failure with left ventricular ejection fraction <50%
- Presence of cardiac valvulopathy, concerning both right and left atrio-ventricular and ventriculo-arterial valves
- Presence of valvular prosthesis
- Congenital heart disease
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 |
|---|---|---|
| Pressure/Volume Combination CatheterHemodynamic data routinely collected and data collected by means of the placement of a Pressure/Volume Combination Catheter (Pressure/Volume Combination Catheter,Leycom,The Netherlands) will be collected simultaneously. The catheter will be placed and held in place as long as the patient is in a position to be assisted by extracorporeal circulation. This means that the placement of the catheter will follow the heparinization of the patient and the placement of the cannulas necessary for the realization of extracorporal circulation. It will be removed from the left ventricular cavity before removal of extra-corporal cannulas. | Device | Elective coronary surgery |
| Transthoracic echocardiographyA complete transthoracic echocardiography will be performed the day before the surgical procedure, as per standard of care. It will establish the presence of the inclusion and exclusion criteria and evaluate the contractile function of the left ventricle. This will be done using a Philips IE33 echocardiograph (Koninklijke Philips Electronics N.V., Netherlands). | Device | Elective coronary surgery |
| Transesophageal echocardiogramA transesophageal echocardiogram will be performed during the cardiac surgery, as per standard of care, using an Acuson Sequoia system (Siemens AG, Germany). It will facilitate the placement of the pressure/volume combination catheter and collect echographic data. | Device | Elective coronary surgery |
Primary outcome
Tele-systolic pressure of the left ventricle
Time frame: Baseline (before extracorporeal circulation is switched on)
Pressure within the left ventricle after the atrial contraction, at the beginning of the ventricular contraction.
Tele-systolic pressure of the left ventricle
Time frame: 1 minute after extracorporeal circulation is switched on
Pressure within the left ventricle after the atrial contraction, at the beginning of the ventricular contraction.
Tele-systolic pressure of the left ventricle
Time frame: 1 minute after extracorporeal circulation is stopped
Pressure within the left ventricle after the atrial contraction, at the beginning of the ventricular contraction.
Tele-systolic pressure of the left ventricle
Time frame: 10 minutes after extracorporeal circulation is stopped
Pressure within the left ventricle after the atrial contraction, at the beginning of the ventricular contraction.
Tele-systolic pressure of the left ventricle
Time frame: 20 minutes after extracorporeal circulation is stopped
Pressure within the left ventricle after the atrial contraction, at the beginning of the ventricular contraction.
Diastolic pressure of the left ventricle
Time frame: Baseline (before extracorporeal circulation is switched on)
The pressure within the left ventricle following the completion of diastolic filling, just prior to systole.
Diastolic pressure of the left ventricle
Time frame: 1 minute after extracorporeal circulation is switched on
The pressure within the left ventricle following the completion of diastolic filling, just prior to systole.
Diastolic pressure of the left ventricle
Time frame: 1 minute after extracorporeal circulation is stopped
The pressure within the left ventricle following the completion of diastolic filling, just prior to systole.
Diastolic pressure of the left ventricle
Time frame: 10 minutes after extracorporeal circulation is stopped
The pressure within the left ventricle following the completion of diastolic filling, just prior to systole.
Diastolic pressure of the left ventricle
Time frame: 20 minutes after extracorporeal circulation is stopped
The pressure within the left ventricle following the completion of diastolic filling, just prior to systole.
Tele-systolic volume of the left ventricle
Time frame: Baseline
At the end of systole, the ventricle contains a quantity of blood called 'telesystolic volume'.
Tele-systolic volume of the left ventricle
Time frame: 1 minute after extracorporeal circulation is switched on
At the end of systole, the ventricle contains a quantity of blood called 'telesystolic volume'.
Tele-systolic volume of the left ventricle
Time frame: 1 minute after extracorporeal circulation is stopped
At the end of systole, the ventricle contains a quantity of blood called 'telesystolic volume'.
Tele-systolic volume of the left ventricle
Time frame: 10 minutes after extracorporeal circulation is stopped
At the end of systole, the ventricle contains a quantity of blood called 'telesystolic volume'.
Tele-systolic volume of the left ventricle
Time frame: 20 minutes after extracorporeal circulation is stopped
At the end of systole, the ventricle contains a quantity of blood called 'telesystolic volume'.
Diastolic volume of the left ventricle
Time frame: Baseline
At the end of diastole, the ventricle contains a quantity of blood called end-diastolic volume.
Diastolic volume of the left ventricle
Time frame: 1 minute after extracorporeal circulation is switched on
At the end of diastole, the ventricle contains a quantity of blood called end-diastolic volume.
Diastolic volume of the left ventricle
Time frame: 1 minute after extracorporeal circulation is stopped
At the end of diastole, the ventricle contains a quantity of blood called end-diastolic volume.
Diastolic volume of the left ventricle
Time frame: 10 minutes after extracorporeal circulation is stopped
At the end of diastole, the ventricle contains a quantity of blood called end-diastolic volume.
Diastolic volume of the left ventricle
Time frame: 20 minutes after extracorporeal circulation is stopped
At the end of diastole, the ventricle contains a quantity of blood called end-diastolic volume.
Ejection volume of the left ventricle
Time frame: Baseline
The ejection volume is the difference between systolic and diastolic volume. It represents the amount of blood ejected at each contraction by the ventricle.
Ejection volume of the left ventricle
Time frame: 1 minute after extracorporeal circulation is switched on
The ejection volume is the difference between systolic and diastolic volume. It represents the amount of blood ejected at each contraction by the ventricle.
Ejection volume of the left ventricle
Time frame: 1 minute after extracorporeal circulation is stopped
The ejection volume is the difference between systolic and diastolic volume. It represents the amount of blood ejected at each contraction by the ventricle.
Ejection volume of the left ventricle
Time frame: 10 minutes after extracorporeal circulation is stopped
The ejection volume is the difference between systolic and diastolic volume. It represents the amount of blood ejected at each contraction by the ventricle.
Ejection volume of the left ventricle
Time frame: 20 minutes after extracorporeal circulation is stopped
The ejection volume is the difference between systolic and diastolic volume. It represents the amount of blood ejected at each contraction by the ventricle.
Contractility index of the left ventricle
Time frame: Baseline
Computed by the following formula: (dP/dt max)/P
Contractility index of the left ventricle
Time frame: 1 minute after extracorporeal circulation is switched on
Computed by the following formula: (dP/dt max)/P
Contractility index of the left ventricle
Time frame: 1 minute after extracorporeal circulation is stopped
Computed by the following formula: (dP/dt max)/P
Contractility index of the left ventricle
Time frame: 10 minutes after extracorporeal circulation is stopped
Computed by the following formula: (dP/dt max)/P
Contractility index of the left ventricle
Time frame: 20 minutes after extracorporeal circulation is stopped
Computed by the following formula: (dP/dt max)/P
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 18 Jan 2020.
- Individual participant dataSharing planned: No
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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.
Charlotte Leclercq, MD principal investigator
CHU Brugmann
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pressure/Volume Combination Catheter, Transthoracic echocardiography and Transesophageal echocardiogram in people with Coronary Surgery, run by Pierre Wauthy at 1 site in Belgium.
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 7 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 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
Tele-systolic pressure of the left ventricle (time frame: Baseline (before extracorporeal circulation is switched on)). The study lists 30 primary outcomes in all. 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 18 Jan 2020.