Hemodialysis ComplicationNCT07019051
Echocardiographic Parameters for Hemodynamic Support During CVVHDF
An observational study of Hemodialysis Complication, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study aims to evaluate whether transthoracic echocardiographic parameters-Left Ventricular Outflow Tract Velocity-Time Integral (LVOT VTI), Mitral Annular Plane Systolic Excursion (MAPSE), Tricuspid Annular Plane Systolic Excursion (TAPSE), S' wave velocity, and E/e' ratio-can predict… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis Complication
- What is being tested?
- Transthoracic Echocardiographic Evaluation
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Jun 2025to 13 Jan 2026
- Phase
- Observational
- 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
Study population: The study population will consist of adult patients (≥18 years) admitted to the intensive care unit (ICU) of a tertiary care hospital who are clinically indicated for continuous veno-venous hemodiafiltration (CVVHDF) due to acute kidney injury or fluid overload. All participants must have adequate transthoracic echocardiographic imaging quality prior to dialysis initiation. Only patients whose legal representatives provide informed consent will be included. Both male and female patients will be enrolled, regardless of underlying comorbidities, provided they meet the inclusion and exclusion criteria.
Who may be able to join
- Age ≥18 years
- Admission to the intensive care unit (ICU)
- Clinical indication for initiation of continuous veno-venous hemodiafiltration (CVVHDF)
- Ability to obtain adequate transthoracic echocardiographic (TTE) images prior to CVVHDF
- Written informed consent obtained from the patient's legal representative
Who cannot join
- Acute coronary syndrome, severe valvular disease, or pericardial effusion affecting cardiac function
- Cardiac arrhythmias such as atrial fibrillation or ventricular tachycardia that interfere with accurate Doppler measurements
- Presence of cardiac devices such as pacemakers, LVADs, or implantable cardioverter defibrillators (ICDs)
- Poor echocardiographic window due to severe lung disease or chest wall abnormalities
- Estimated life expectancy <24 hours or do-not-resuscitate (DNR) orders in place
- Inability to obtain informed consent due to lack of legal representative
- Transfer to another facility before CVVHDF initiation or change in renal replacement strategy (e.g., switch to peritoneal dialysis)
- Incomplete echocardiographic measurement due to technical limitations
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital
Istanbul, Istanbul, 34303
About this study
Official title: Predictive Role of Echocardiographic Parameters for Hemodynamic Support Needs During Initiation of Continuous Venovenous Hemodiafiltration in ICU Patients
This prospective observational study aims to evaluate whether transthoracic echocardiographic parameters-Left Ventricular Outflow Tract Velocity-Time Integral (LVOT VTI), Mitral Annular Plane Systolic Excursion (MAPSE), Tricuspid Annular Plane Systolic Excursion (TAPSE), S' wave velocity, and E/e' ratio-can predict hemodynamic instability at the initiation of sustained low-efficiency daily dialysis (SVVHDF) in intensive care unit (ICU) patients. The study will include adult patients requiring SVVHDF, and echocardiographic measurements will be performed prior to dialysis. The primary outcome is the need for hemodynamic support (vasopressors/inotropes or fluid resuscitation) or development of hypotension within the first 60 minutes of dialysis. The study aims to identify which of these parameters best predict the need for hemodynamic intervention, with the goal of supporting individualized dialysis planning and safer fluid management in critically ill patients.
Read the detailed description
This prospective, single-center observational study is designed to investigate the predictive value of specific transthoracic echocardiographic (TTE) parameters in assessing the risk of hemodynamic instability during the initiation of sustained low-efficiency daily dialysis (SVVHDF) in critically ill patients. The primary focus is to determine whether measurements obtained immediately before dialysis-namely LVOT VTI, MAPSE, TAPSE, S', and E/e'-can identify patients at risk of hypotension or the need for hemodynamic support within the first hour of treatment.
All echocardiographic assessments will be performed by certified intensive care specialists or cardiologists using standard parasternal and apical windows. The parameters to be evaluated include:
LVOT VTI (Left Ventricular Outflow Tract Velocity-Time Integral):
Measured via pulsed wave Doppler from the apical 5-chamber view, this value reflects stroke volume and overall cardiac output. A low LVOT VTI may indicate hypovolemia or decreased systolic function.
MAPSE (Mitral Annular Plane Systolic Excursion):
Obtained using M-mode in the apical 4-chamber view by measuring the displacement of the mitral annulus during systole. It is an index of longitudinal left ventricular systolic function; values <10 mm may suggest early left ventricular dysfunction.
TAPSE (Tricuspid Annular Plane Systolic Excursion):
Also measured with M-mode in the apical 4-chamber view, TAPSE reflects right ventricular systolic function. Values <17 mm are indicative of right ventricular dysfunction.
S' (S Prime) Wave:
Using tissue Doppler imaging (TDI) at the mitral and/or tricuspid annulus, this parameter evaluates longitudinal systolic myocardial velocity. Reduced S' values suggest impaired ventricular contractility.
E/e' Ratio:
Calculated from pulsed Doppler and TDI values, this ratio estimates left ventricular filling pressures. An E/e' >15 is associated with elevated filling pressure, while <8 suggests normal filling.
Patients will be monitored for hemodynamic instability within the first 60 minutes following SVVHDF initiation. The primary hemodynamic outcomes include:
Hypotension: Defined as a mean arterial pressure (MAP) <65 mmHg or a ≥20% decrease in MAP compared to baseline values prior to dialysis initiation.
Need for Vasopressor or Inotrope Support: Initiation of medications such as norepinephrine, dopamine, or dobutamine during the first hour of dialysis.
Need for Additional Fluid Resuscitation: Defined as administration of ≥500 mL crystalloid or colloid solution within 60 minutes due to clinical signs of volume depletion.
Clinical decisions related to dialysis and hemodynamic management will be made solely by the treating physicians, with study investigators collecting data in an observational capacity. All echocardiographic and hemodynamic data will be anonymized and stored securely for statistical analysis.
This study aims to identify echocardiographic biomarkers that can improve the safety and personalization of dialysis management in ICU settings, with potential applications extending to chronic dialysis centers in the future.
- Conditions
- Hemodialysis Complication
- Being tested
- Transthoracic Echocardiographic Evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transthoracic Echocardiographic EvaluationDiagnostic test
Non-invasive transthoracic echocardiography will be performed prior to the initiation of continuous veno-venous hemodiafiltration (CVVHDF) in ICU patients. The evaluation includes measurements of LVOT VTI, MAPSE, TAPSE, S' wave velocity, and E/e' ratio to assess cardiac function and estimate the risk of hemodynamic instability. The procedure will be conducted at the bedside using standard parasternal and apical windows by trained intensive care physicians or cardiologists. No contrast, sedation, or invasive monitoring will be used.
| Study group | Role | What they receive |
|---|---|---|
| CVVHDF Candidates in ICU | Adult intensive care unit (ICU) patients who are scheduled to undergo continuous veno-venous hemodiafiltration (CVVHDF). All participants will undergo transthoracic echocardiographic evaluation prior to dialysis initiation. Hemodynamic parameters will be monitored for 60 minutes following the start of CVVHDF to assess the development of hypotension or the need for vasopressor, inotropic, or fluid support. Receives: Diagnostic Test: Transthoracic Echocardiographic Evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Hemodynamic Instability Within the First 60 Minutes of CVVHDF and Its Association With Pre-Dialysis LVOT VTI
Hemodynamic instability will be recorded within the first 60 minutes after initiation of continuous veno-venous hemodiafiltration (CVVHDF). Instability is defined by the occurrence of any of the following:
Mean arterial pressure (MAP) < 65 mmHg,
≥30% decrease in MAP from pre-CVVHDF baseline,
Initiation of vasopressors or inotropes,
Administration of ≥500 mL of intravenous fluid bolus for resuscitation.
Each patient's Left Ventricular Outflow Tract Velocity-Time Integral (LVOT VTI) will be measured by transthoracic echocardiography prior to CVVHDF initiation.
Measured: Within the first 60 minutes of CVVHDF initiation
Secondary outcomes (4)
Association Between Pre-Dialysis MAPSE Values and Hemodynamic Instability Within the First 60 Minutes of CVVHDF
Mitral Annular Plane Systolic Excursion (MAPSE) will be measured using transthoracic echocardiography prior to the initiation of continuous veno-venous hemodiafiltration (CVVHDF). Hemodynamic instability will be defined as the occurrence of any of the following events within 60 minutes of CVVHDF initiation:
Mean arterial pressure (MAP) < 65 mmHg,
≥30% reduction in MAP from baseline,
Need for vasopressors or inotropes,
Requirement of ≥500 mL intravenous fluid bolus.
Measured: Within the first 60 minutes of CVVHDF initiation
Association Between Pre-Dialysis TAPSE Values and Hemodynamic Instability Within the First 60 Minutes of CVVHDF
Tricuspid Annular Plane Systolic Excursion (TAPSE) will be measured using transthoracic echocardiography prior to the initiation of continuous veno-venous hemodiafiltration (CVVHDF). Hemodynamic instability will be recorded during the first 60 minutes after CVVHDF initiation and defined as the occurrence of any of the following:
Mean arterial pressure (MAP) < 65 mmHg,
≥30% reduction in MAP from baseline,
Use of vasopressors or inotropes,
Administration of ≥500 mL of intravenous fluid for resuscitation.
Measured: Within the first 60 minutes of CVVHDF initiation
Association Between Pre-Dialysis S' Wave Velocity (cm/s) Measured by Tissue Doppler Imaging and Hemodynamic Instability During the First 60 Minutes of CVVHDF
Systolic S' wave velocity (in cm/s) will be measured by tissue Doppler imaging of the tricuspid annulus via transthoracic echocardiography prior to the initiation of continuous veno-venous hemodiafiltration (CVVHDF). Hemodynamic instability will be defined as any of the following occurring within the first 60 minutes of dialysis:
Mean arterial pressure (MAP) < 65 mmHg,
≥30% decrease in MAP from baseline,
Requirement for vasopressors or inotropes,
Administration of ≥500 mL intravenous fluid bolus.
Measured: Within the first 60 minutes of CVVHDF initiation
Association Between Pre-Dialysis E/e' Ratio and Hemodynamic Instability Within the First 60 Minutes of CVVHDF
The E/e' ratio will be calculated using pulsed-wave Doppler (for mitral inflow E wave) and tissue Doppler imaging (for early diastolic mitral annular e' velocity) obtained via transthoracic echocardiography prior to initiation of continuous veno-venous hemodiafiltration (CVVHDF).
Hemodynamic instability will be defined as the occurrence of any of the following within the first 60 minutes of CVVHDF:
Mean arterial pressure (MAP) < 65 mmHg,
≥30% decrease in MAP from baseline,
Initiation of vasopressors or inotropes,
Requirement for ≥500 mL intravenous fluid bolus.
Measured: Within the first 60 minutes of CVVHDF initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start23 Jun 2025
- Primary completion13 Jan 2026
- Study completion13 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialysis ComplicationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Engin Ihsan Turan, Kanuni Sultan Suleyman Training and Research Hospital
- Investigators
- Engin ihsan Turan, Specialist, Principal investigator, Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07019051
- Sponsor's protocol ID
- lvot vti AKIN
- Status last verified
- Jan 2026
- First submitted
- 28 May 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) will be made available to qualified researchers upon reasonable request. The shared data will include echocardiographic parameters (LVOT VTI, MAPSE, TAPSE, S', E/e'), hemodynamic measurements, and outcome data related to the development of hemodynamic instability following the initiation of CVVHDF. Personal identifiers will be removed to ensure privacy and compliance with ethical standards.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Role of Echocardiographic Parameters for Hemodynamic Support Needs During Initiation of Continuous Venovenous Hemodiafiltration in ICU Patients
- ClinicalTrials.gov ID
- NCT07019051
- Acronym / sponsor ID
- lvot vti AKIN
- Conditions
- Hemodialysis Complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 23 Jun 2025 (actual)
- Primary completion
- 13 Jan 2026 (actual)
- Study completion
- 13 Jan 2026 (actual)
- First posted
- 13 Jun 2025 (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.
This prospective observational study aims to evaluate whether transthoracic echocardiographic parameters-Left Ventricular Outflow Tract Velocity-Time Integral (LVOT VTI), Mitral Annular Plane Systolic Excursion (MAPSE), Tricuspid Annular Plane Systolic Excursion (TAPSE), S' wave velocity, and E/e' ratio-can predict hemodynamic instability at the initiation of sustained low-efficiency daily dialysis (SVVHDF) in intensive care unit (ICU) patients. The study will include adult patients requiring SVVHDF, and echocardiographic measurements will be performed prior to dialysis. The primary outcome is the need for hemodynamic support (vasopressors/inotropes or fluid resuscitation) or development of hypotension within the first 60 minutes of dialysis. The study aims to identify which of these parameters best predict the need for hemodynamic intervention, with the goal of supporting individualized dialysis planning and safer fluid management in critically ill patients.
Detailed description
This prospective, single-center observational study is designed to investigate the predictive value of specific transthoracic echocardiographic (TTE) parameters in assessing the risk of hemodynamic instability during the initiation of sustained low-efficiency daily dialysis (SVVHDF) in critically ill patients. The primary focus is to determine whether measurements obtained immediately before dialysis-namely LVOT VTI, MAPSE, TAPSE, S', and E/e'-can identify patients at risk of hypotension or the need for hemodynamic support within the first hour of treatment.
All echocardiographic assessments will be performed by certified intensive care specialists or cardiologists using standard parasternal and apical windows. The parameters to be evaluated include:
LVOT VTI (Left Ventricular Outflow Tract Velocity-Time Integral):
Measured via pulsed wave Doppler from the apical 5-chamber view, this value reflects stroke volume and overall cardiac output. A low LVOT VTI may indicate hypovolemia or decreased systolic function.
MAPSE (Mitral Annular Plane Systolic Excursion):
Obtained using M-mode in the apical 4-chamber view by measuring the displacement of the mitral annulus during systole. It is an index of longitudinal left ventricular systolic function; values <10 mm may suggest early left ventricular dysfunction.
TAPSE (Tricuspid Annular Plane Systolic Excursion):
Also measured with M-mode in the apical 4-chamber view, TAPSE reflects right ventricular systolic function. Values <17 mm are indicative of right ventricular dysfunction.
S' (S Prime) Wave:
Using tissue Doppler imaging (TDI) at the mitral and/or tricuspid annulus, this parameter evaluates longitudinal systolic myocardial velocity. Reduced S' values suggest impaired ventricular contractility.
E/e' Ratio:
Calculated from pulsed Doppler and TDI values, this ratio estimates left ventricular filling pressures. An E/e' >15 is associated with elevated filling pressure, while <8 suggests normal filling.
Patients will be monitored for hemodynamic instability within the first 60 minutes following SVVHDF initiation. The primary hemodynamic outcomes include:
Hypotension: Defined as a mean arterial pressure (MAP) <65 mmHg or a ≥20% decrease in MAP compared to baseline values prior to dialysis initiation.
Need for Vasopressor or Inotrope Support: Initiation of medications such as norepinephrine, dopamine, or dobutamine during the first hour of dialysis.
Need for Additional Fluid Resuscitation: Defined as administration of ≥500 mL crystalloid or colloid solution within 60 minutes due to clinical signs of volume depletion.
Clinical decisions related to dialysis and hemodynamic management will be made solely by the treating physicians, with study investigators collecting data in an observational capacity. All echocardiographic and hemodynamic data will be anonymized and stored securely for statistical analysis.
This study aims to identify echocardiographic biomarkers that can improve the safety and personalization of dialysis management in ICU settings, with potential applications extending to chronic dialysis centers in the future.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CVVHDF Candidates in ICU | – | Diagnostic Test: Transthoracic Echocardiographic EvaluationAdult intensive care unit (ICU) patients who are scheduled to undergo continuous veno-venous hemodiafiltration (CVVHDF). All participants will undergo transthoracic echocardiographic evaluation prior to dialysis initiation. Hemodynamic parameters will be monitored for 60 minutes following the start of CVVHDF to assess the development of hypotension or the need for vasopressor, inotropic, or fluid support. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adult patients (≥18 years) admitted to the intensive care unit (ICU) of a tertiary care hospital who are clinically indicated for continuous veno-venous hemodiafiltration (CVVHDF) due to acute kidney injury or fluid overload. All participants must have adequate transthoracic echocardiographic imaging quality prior to dialysis initiation. Only patients whose legal representatives provide informed consent will be included. Both male and female patients will be enrolled, regardless of underlying comorbidities, provided they meet the inclusion and exclusion criteria.
Key inclusion criteria (5 listed)
- Age ≥18 years
- Admission to the intensive care unit (ICU)
- Clinical indication for initiation of continuous veno-venous hemodiafiltration (CVVHDF)
- Ability to obtain adequate transthoracic echocardiographic (TTE) images prior to CVVHDF
- Written informed consent obtained from the patient's legal representative
Key exclusion criteria (8 listed)
- Acute coronary syndrome, severe valvular disease, or pericardial effusion affecting cardiac function
- Cardiac arrhythmias such as atrial fibrillation or ventricular tachycardia that interfere with accurate Doppler measurements
- Presence of cardiac devices such as pacemakers, LVADs, or implantable cardioverter defibrillators (ICDs)
- Poor echocardiographic window due to severe lung disease or chest wall abnormalities
- Estimated life expectancy <24 hours or do-not-resuscitate (DNR) orders in place
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 |
|---|---|---|
| Transthoracic Echocardiographic EvaluationNon-invasive transthoracic echocardiography will be performed prior to the initiation of continuous veno-venous hemodiafiltration (CVVHDF) in ICU patients. The evaluation includes measurements of LVOT VTI, MAPSE, TAPSE, S' wave velocity, and E/e' ratio to assess cardiac function and estimate the risk of hemodynamic instability. The procedure will be conducted at the bedside using standard parasternal and apical windows by trained intensive care physicians or cardiologists. No contrast, sedation, or invasive monitoring will be used. | Diagnostic test | CVVHDF Candidates in ICU |
Primary outcome
Occurrence of Hemodynamic Instability Within the First 60 Minutes of CVVHDF and Its Association With Pre-Dialysis LVOT VTI
Time frame: Within the first 60 minutes of CVVHDF initiation
Hemodynamic instability will be recorded within the first 60 minutes after initiation of continuous veno-venous hemodiafiltration (CVVHDF). Instability is defined by the occurrence of any of the following: Mean arterial pressure (MAP) < 65 mmHg, ≥30% decrease in MAP from pre-CVVHDF baseline, Initiation of vasopressors or inotropes, Administration of ≥500 mL of intravenous fluid bolus for resuscitation. Each patient's Left Ventricular Outflow Tract Velocity-Time Integral (LVOT VTI) will be measured by transthoracic echocardiography prior to CVVHDF initiation.
4 secondary outcomes
Association Between Pre-Dialysis MAPSE Values and Hemodynamic Instability Within the First 60 Minutes of CVVHDF
Time frame: Within the first 60 minutes of CVVHDF initiation
Association Between Pre-Dialysis TAPSE Values and Hemodynamic Instability Within the First 60 Minutes of CVVHDF
Time frame: Within the first 60 minutes of CVVHDF initiation
Association Between Pre-Dialysis S' Wave Velocity (cm/s) Measured by Tissue Doppler Imaging and Hemodynamic Instability During the First 60 Minutes of CVVHDF
Time frame: Within the first 60 minutes of CVVHDF initiation
Association Between Pre-Dialysis E/e' Ratio and Hemodynamic Instability Within the First 60 Minutes of CVVHDF
Time frame: Within the first 60 minutes of CVVHDF initiation
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 15 Jan 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) will be made available to qualified researchers upon reasonable request. The shared data will include echocardiographic parameters (LVOT VTI, MAPSE, TAPSE, S', E/e'), hemodynamic measurements, and outcome data related to the development of hemodynamic instability following the initiation of CVVHDF. Personal identifiers will be removed to ensure privacy and compliance with ethical standards.
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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.
Engin ihsan Turan, Specialist principal investigator
Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemodialysis Complication, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
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 5 inclusion and 8 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 15 Jan 2026. 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 Turkey (Türkiye). 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?
Occurrence of Hemodynamic Instability Within the First 60 Minutes of CVVHDF and Its Association With Pre-Dialysis LVOT VTI (time frame: Within the first 60 minutes of CVVHDF initiation). 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 15 Jan 2026.