Right Ventricular DysfunctionIMPRoVENCT05827315
Incidence, Impact and Mechanisms of Perioperative Right VEntricular Dysfunction (IMPRoVE)
An observational study of Right Ventricular Dysfunction, run by NHS National Waiting Times Centre Board at 3 sites in United Kingdom.
Trial summary
A study to see how common right heart failure (right ventricular dysfunction) after major surgery is, and to investigate if right ventricular dysfunction causes worse patient outcomes after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Right Ventricular Dysfunction
- What is being tested?
- Echocardiography, T1 Cardiovascular Magnetic Resonance and Right heart catheterisation and coronary sinus blood sampling
- How many people
- 175 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Apr 2023to Apr 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: 175 patients of 18 years or older undergoing major non-cardiac surgery in the West of Scotland. Patients will be recruited from the Golden Jubilee National Hospital, Queen Elizabeth University Hospital, and Glasgow Royal Infirmary.
Who may be able to join
- Provision of informed consent
- Age >18 years
- Planned elective primary hip or knee joint replacement under spinal anaesthesia, major colorectal, major vascular surgery or surgery requiring one lung ventilation with or without lung resection
Who cannot join
- Pregnancy
- On-going participation in any investigational research which could undermine the scientific basis of the study
- Previous major surgery within three months prior to recruitment
- Previous participation in the IMPRoVE study at any time
- Inadequate comprehension of English resulting in inability to comply with instructions while undergoing investigations required for main study and sub-studies.
- Additional exclusion criteria applicable to the T1 CMR sub-study includes:
Show all 9Show fewer
- Atrial fibrillation at baseline
- Contraindication to cardiac magnetic resonance imaging (metal work in body etc)
- Contraindication to IV Gadolinium: acute or chronic renal failure, allergy to contrast
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Golden Jubilee National Hospital
Clydebank
Ben Shelley, 0141 9515000 ext. 4293
Ben Shelley
Glasgow Royal Infirmary
Glasgow, G4 0SF
Rachel Kearns, 0141 211 4000
Rachel Kearns
Queen Elizabeth University Hospital
Glasgow, G51 4TF
Malcolm Watson
Malcolm Watson
About this study
A study to see how common right heart failure (right ventricular dysfunction) after major surgery is, and to investigate if right ventricular dysfunction causes worse patient outcomes after surgery.
Read the detailed description
Heart attacks are relatively rare around the time of surgery, however by measuring blood markers of heart injury, recent research has revealed that heart injury which otherwise may not be immediately obvious is common. Whilst this type of heart injury appears to be strongly linked to patient outcomes (complications, recovery and survival), the causes and potential treatments for it are not well understood.
Our research group has specialist knowledge about the right-hand side of the heart (right-heart) - the side that pumps blood through the lungs - which is less commonly considered or studied around the time of surgery. We have shown in previous studies using magnetic resonance imaging (MRI) scans (specialised whole-body scans which use a magnet rather than X-rays), evidence of right-heart function deteriorating after surgery. We want to test the idea that some of the blood marker evidence of heart injury reflects injury to the right-heart and more importantly that we can protect the right-heart around the time of surgery, reducing injury and improving patient outcomes.
We will examine these questions in the following ways:
- With patients' permission, we will perform detailed ultrasound scans of the heart (echocardiography), and blood measurement of injury markers in 175 patients undergoing different types of major surgery. This will allow us to assess how common heart injury is (visible on scans of both sides of the heart), whether it makes any difference to a patient's outcome and whether it explains the changes seen in blood markers.
- We will ask 50 of these patients to undergo MRI scans of the heart pre- and post-operatively to allow us to identify evidence of injury resulting from heart inflammation around the time of surgery. Inflammation is common following surgery and occurs throughout a patient's body - we believe heart inflammation may be responsible for postoperative heart injury.
- In 10 of these patients, we will seek to obtain blood samples from vessels flowing into the heart (easily obtained from a simple blood sample) and from veins flowing out of the heart, obtained by passing a fine tube into the heart via blood vessels in a patient's neck under X-ray guidance. This will allow us to examine what happens to immune cells as they pass through the heart (i.e., are they activated by heart inflammation?) and better understand the meaning of the changes seen on MRI scans.
This study will give us a better understanding of which patients are likely to suffer heart injury around the time of surgery and how this injury occurs. With this knowledge, future patients could receive personalised treatment plans aimed at preventing injury and improving outcomes. We are not testing any new treatments in this study.
- Conditions
- Right Ventricular Dysfunction
- Being tested
- Echocardiography, T1 Cardiovascular Magnetic Resonance, Right heart catheterisation and coronary sinus blood sampling
- Keywords
- Echocardiography, T1 CMR, Major non-cardiac surgery, Perioperative Complication, Postoperative myocardial injury, Right heart catheterisation, Coronary sinus sampling
- Medical subject headings
- Ventricular Dysfunction, Right
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyDiagnostic test
Echocardiography will be performed by BSE accredited echocardiographers in all 175 patients preoperatively and on day 2-4 postoperatively.
T1 Cardiovascular Magnetic ResonanceDiagnostic test
T1 CMR will be performed in 10 patients from each of the 5 surgical groups (50 patients in total) preoperatively and on day 2-4 postoperatively.
Right heart catheterisation and coronary sinus blood samplingDiagnostic test
10 patients from the thoracic surgical group will undergo right heart catheterisation and coronary sinus blood sampling.
| Study group | Role | What they receive |
|---|---|---|
| Thoracic surgery cohort | 35 patients undergoing thoracic surgery with lung resection and one lung ventilation under primarily general anaesthesia. Receives: Diagnostic Test: Echocardiography; Diagnostic Test: T1 Cardiovascular Magnetic Resonance; Diagnostic Test: Right heart catheterisation and coronary sinus blood sampling | |
| Upper gastrointestinal surgery cohort | 35 patients undergoing upper gastrointestinal surgery with one lung ventilation under primarily general anaesthesia. Receives: Diagnostic Test: Echocardiography; Diagnostic Test: T1 Cardiovascular Magnetic Resonance | |
| Colorectal surgery cohort | 35 patients undergoing elective colorectal surgery under primarily general anaesthesia. Receives: Diagnostic Test: Echocardiography; Diagnostic Test: T1 Cardiovascular Magnetic Resonance | |
| Vascular surgery cohort | 35 patients undergoing elective open abdominal aortic surgery under primarily general anaesthesia. Receives: Diagnostic Test: Echocardiography; Diagnostic Test: T1 Cardiovascular Magnetic Resonance | |
| Orthopaedic surgery cohort | 35 patients undergoing elective primary hip or knee arthroplasty under spinal anaesthesia +/- sedation. Receives: Diagnostic Test: Echocardiography; Diagnostic Test: T1 Cardiovascular Magnetic Resonance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative Right ventricular dysfunction (RVD)
RVD diagnosed by transthoracic echocardiography, defined as:
- 2D-speckle tracking derived RV free wall peak longitudinal strain (FWLS) less negative than -20%.
- Or, (where not available) two of Tricuspid Annular Plane Systolic Excursion (TAPSE) <16mm, S' Wave velocity at the tricuspid annulus <10cm/s or tissue doppler RV index of myocardial performance >0.55
Measured: Echocardiography performed preoperatively and at day 2-4 postoperatively to measure change in RV function
Days alive and at home at 30 days postoperatively (DAH30)
DAH30 is a continuous number between 0 and 30 which reflects, out of the 30 days following surgery, the total number of those days that a patient spends alive and at home. If a patient dies within those 30 days, their value is set to 0. Data for DAH30 will be obtained by follow-up phone calls following the 30th postoperative day.
Measured: Day 30 postoperatively
Secondary outcomes (11)
Incidence of postoperative left ventricular dysfunction (LVD)
LVD classified as mild, moderately or severely impaired, defined by 2D-echocardiography derived biplane LV ejection fraction and the presence of wall motion abnormalities.
Measured: Echocardiography performed preoperatively and at day 2-4 postoperatively to measure change in LV function
Cardiac biomarkers
Natriuretic peptides and high sensitivity troponin will be measured pre- and postoperatively.
Measured: BNP and troponin measured preoperatively, on postoperative days 1 and 2 and on day of postoperative echocardiography (occurring on postoperative days 2-4).
Cardiovascular complications
Incidence of myocardial infarction, cardiac death, non-fatal cardiac arrest, coronary revascularisation, pulmonary embolus, deep-veined thrombosis, or new onset atrial fibrillation, and major adverse cardiac events
Measured: Day of postoperative echocardiography (day 2-4 postoperatively) and at discharge (on average one week).
Renal outcomes
Kidney Disease Improving Global Outcome (KDIGO) classification of Acute Kidney Injury (AKI).
Measured: Day of postoperative echocardiography (day 2-4 postoperatively) and at discharge (on average one week).
Pulmonary outcomes
Atelectasis, pneumonia, acute respiratory distress syndrome or pulmonary aspiration
Measured: Day of postoperative echocardiography (day 2-4 postoperatively) and at discharge (on average one week).
Infection Outcomes
Fever and clinical suspicion of infection
Measured: Day of postoperative echocardiography (day 2-4 postoperatively) and at discharge (on average one week).
Neurological outcomes
Delirium and stroke
Measured: Day of postoperative echocardiography (day 2-4 postoperatively) and at discharge (on average one week).
Sequential Organ Failure Assessment (SOFA) Score
Score 0-24, where higher scores are a worse outcome.
Measured: Postoperative day 1,2, day of postoperative echocardiography in all patients. In patients admitted to HDU/ICU, SOFA score will be collected from postoperative day 0-7.
Fifteen-point Quality of Recovery Score (QoR-15)
Fifteen questions assessing the quality of a patients recovery, each question is scored 0-10 with higher scores indicating a worse outcome.
Measured: Pre-operatively and day of postoperative echocardiography (day 2-4 postoperatively).
World Health Organisation Disability Assessment Schedule 2.0 (WHODAS 2.0)
WHODAS 2.0 is a self administered questionnaire that assesses a patient's health and disability. Twelve questions are scored 0-4, where a higher score indicates a worse outcome.
Measured: Preoperatively, and at day 30, day 90, and one year postoperatively.
EuroQoL Dimension Health Related Quality of Life Questionnaire (EQ-5D-5L)
EQ-5D-5L is a self administered questionnaire that assesses 5 dimensions of a patient's quality of life. Each dimension is scored 1-5, where a higher score indicates a worse outcome.
Measured: Preoperatively, and at day 30, day 90, and one year postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study startApr 2023 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Right Ventricular DysfunctionStudies 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
- 175 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS National Waiting Times Centre Board
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow, NHS Greater Glasgow and Clyde, Royal London Hospital
- Responsible party
- Principal investigator, Dr Ben Shelley, University of Glasgow
- Investigators
- Ben Shelley, Principal investigator, National Waiting Times Centre Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05827315
- Sponsor's protocol ID
- 22/ANAES/06
- Acronym
- IMPRoVE
- Status last verified
- Apr 2023
- First submitted
- 27 Mar 2023
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Keast T, McErlane J, Kearns R, McKinlay S, Raju I, Watson M, Robertson KE, Berry C, Greenlaw N, Ackland G, McCall P, Shelley B. Study protocol for IMPRoVE: a multicentre prospective observational cohort study of the incidence, impact and mechanisms of perioperative right ventricular dysfunction in non-cardiac surgery. BMJ Open. 2023 Sep 6;13(9):e074687. doi: 10.1136/bmjopen-2023-074687.
PubMed 37673452
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence, Impact and Mechanisms of Perioperative Right VEntricular Dysfunction (IMPRoVE)
- ClinicalTrials.gov ID
- NCT05827315
- Acronym / sponsor ID
- IMPRoVE / 22/ANAES/06
- Conditions
- Right Ventricular Dysfunction
- Keywords
- Echocardiography, T1 CMR, Major non-cardiac surgery, Perioperative Complication, Postoperative myocardial injury, Right heart catheterisation, Coronary sinus sampling
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 175 participants (estimated)
- Lead sponsor
- NHS National Waiting Times Centre BoardUniversity, hospital or other
- Collaborators
- University of Glasgow, NHS Greater Glasgow and Clyde, Royal London Hospital
- Study start
- Apr 2023 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 25 Apr 2023 (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.
A study to see how common right heart failure (right ventricular dysfunction) after major surgery is, and to investigate if right ventricular dysfunction causes worse patient outcomes after surgery.
Detailed description
Heart attacks are relatively rare around the time of surgery, however by measuring blood markers of heart injury, recent research has revealed that heart injury which otherwise may not be immediately obvious is common. Whilst this type of heart injury appears to be strongly linked to patient outcomes (complications, recovery and survival), the causes and potential treatments for it are not well understood.
Our research group has specialist knowledge about the right-hand side of the heart (right-heart) - the side that pumps blood through the lungs - which is less commonly considered or studied around the time of surgery. We have shown in previous studies using magnetic resonance imaging (MRI) scans (specialised whole-body scans which use a magnet rather than X-rays), evidence of right-heart function deteriorating after surgery. We want to test the idea that some of the blood marker evidence of heart injury reflects injury to the right-heart and more importantly that we can protect the right-heart around the time of surgery, reducing injury and improving patient outcomes.
We will examine these questions in the following ways:
- With patients' permission, we will perform detailed ultrasound scans of the heart (echocardiography), and blood measurement of injury markers in 175 patients undergoing different types of major surgery. This will allow us to assess how common heart injury is (visible on scans of both sides of the heart), whether it makes any difference to a patient's outcome and whether it explains the changes seen in blood markers.
- We will ask 50 of these patients to undergo MRI scans of the heart pre- and post-operatively to allow us to identify evidence of injury resulting from heart inflammation around the time of surgery. Inflammation is common following surgery and occurs throughout a patient's body - we believe heart inflammation may be responsible for postoperative heart injury.
- In 10 of these patients, we will seek to obtain blood samples from vessels flowing into the heart (easily obtained from a simple blood sample) and from veins flowing out of the heart, obtained by passing a fine tube into the heart via blood vessels in a patient's neck under X-ray guidance. This will allow us to examine what happens to immune cells as they pass through the heart (i.e., are they activated by heart inflammation?) and better understand the meaning of the changes seen on MRI scans.
This study will give us a better understanding of which patients are likely to suffer heart injury around the time of surgery and how this injury occurs. With this knowledge, future patients could receive personalised treatment plans aimed at preventing injury and improving outcomes. We are not testing any new treatments in this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Thoracic surgery cohort | – | Diagnostic Test: Echocardiography, Diagnostic Test: T1 Cardiovascular Magnetic Resonance, Diagnostic Test: Right heart catheterisation and coronary sinus blood sampling35 patients undergoing thoracic surgery with lung resection and one lung ventilation under primarily general anaesthesia. |
| Upper gastrointestinal surgery cohort | – | Diagnostic Test: Echocardiography, Diagnostic Test: T1 Cardiovascular Magnetic Resonance35 patients undergoing upper gastrointestinal surgery with one lung ventilation under primarily general anaesthesia. |
| Colorectal surgery cohort | – | Diagnostic Test: Echocardiography, Diagnostic Test: T1 Cardiovascular Magnetic Resonance35 patients undergoing elective colorectal surgery under primarily general anaesthesia. |
| Vascular surgery cohort | – | Diagnostic Test: Echocardiography, Diagnostic Test: T1 Cardiovascular Magnetic Resonance35 patients undergoing elective open abdominal aortic surgery under primarily general anaesthesia. |
| Orthopaedic surgery cohort | – | Diagnostic Test: Echocardiography, Diagnostic Test: T1 Cardiovascular Magnetic Resonance35 patients undergoing elective primary hip or knee arthroplasty under spinal anaesthesia +/- sedation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 175 patients of 18 years or older undergoing major non-cardiac surgery in the West of Scotland. Patients will be recruited from the Golden Jubilee National Hospital, Queen Elizabeth University Hospital, and Glasgow Royal Infirmary.
Key inclusion criteria (3 listed)
- Provision of informed consent
- Age >18 years
- Planned elective primary hip or knee joint replacement under spinal anaesthesia, major colorectal, major vascular surgery or surgery requiring one lung ventilation with or without lung resection
Key exclusion criteria (9 listed)
- Pregnancy
- On-going participation in any investigational research which could undermine the scientific basis of the study
- Previous major surgery within three months prior to recruitment
- Previous participation in the IMPRoVE study at any time
- Inadequate comprehension of English resulting in inability to comply with instructions while undergoing investigations required for main study and sub-studies.
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 |
|---|---|---|
| EchocardiographyEchocardiography will be performed by BSE accredited echocardiographers in all 175 patients preoperatively and on day 2-4 postoperatively. | Diagnostic test | Colorectal surgery cohort, Orthopaedic surgery cohort, Thoracic surgery cohort, Upper gastrointestinal surgery cohort, Vascular surgery cohort |
| T1 Cardiovascular Magnetic ResonanceT1 CMR will be performed in 10 patients from each of the 5 surgical groups (50 patients in total) preoperatively and on day 2-4 postoperatively. | Diagnostic test | Colorectal surgery cohort, Orthopaedic surgery cohort, Thoracic surgery cohort, Upper gastrointestinal surgery cohort, Vascular surgery cohort |
| Right heart catheterisation and coronary sinus blood sampling10 patients from the thoracic surgical group will undergo right heart catheterisation and coronary sinus blood sampling. | Diagnostic test | Thoracic surgery cohort |
Primary outcome
Incidence of postoperative Right ventricular dysfunction (RVD)
Time frame: Echocardiography performed preoperatively and at day 2-4 postoperatively to measure change in RV function
RVD diagnosed by transthoracic echocardiography, defined as: * 2D-speckle tracking derived RV free wall peak longitudinal strain (FWLS) less negative than -20%. * Or, (where not available) two of Tricuspid Annular Plane Systolic Excursion (TAPSE) <16mm, S' Wave velocity at the tricuspid annulus <10cm/s or tissue doppler RV index of myocardial performance >0.55
Days alive and at home at 30 days postoperatively (DAH30)
Time frame: Day 30 postoperatively
DAH30 is a continuous number between 0 and 30 which reflects, out of the 30 days following surgery, the total number of those days that a patient spends alive and at home. If a patient dies within those 30 days, their value is set to 0. Data for DAH30 will be obtained by follow-up phone calls following the 30th postoperative day.
11 secondary outcomes
Incidence of postoperative left ventricular dysfunction (LVD)
Time frame: Echocardiography performed preoperatively and at day 2-4 postoperatively to measure change in LV function
Cardiac biomarkers
Time frame: BNP and troponin measured preoperatively, on postoperative days 1 and 2 and on day of postoperative echocardiography (occurring on postoperative days 2-4).
Cardiovascular complications
Time frame: Day of postoperative echocardiography (day 2-4 postoperatively) and at discharge (on average one week).
Renal outcomes
Time frame: Day of postoperative echocardiography (day 2-4 postoperatively) and at discharge (on average one week).
Pulmonary outcomes
Time frame: Day of postoperative echocardiography (day 2-4 postoperatively) and at discharge (on average one week).
Infection Outcomes
Time frame: Day of postoperative echocardiography (day 2-4 postoperatively) and at discharge (on average one week).
Neurological outcomes
Time frame: Day of postoperative echocardiography (day 2-4 postoperatively) and at discharge (on average one week).
Sequential Organ Failure Assessment (SOFA) Score
Time frame: Postoperative day 1,2, day of postoperative echocardiography in all patients. In patients admitted to HDU/ICU, SOFA score will be collected from postoperative day 0-7.
Fifteen-point Quality of Recovery Score (QoR-15)
Time frame: Pre-operatively and day of postoperative echocardiography (day 2-4 postoperatively).
World Health Organisation Disability Assessment Schedule 2.0 (WHODAS 2.0)
Time frame: Preoperatively, and at day 30, day 90, and one year postoperatively.
EuroQoL Dimension Health Related Quality of Life Questionnaire (EQ-5D-5L)
Time frame: Preoperatively, and at day 30, day 90, and one year postoperatively.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Derived from this study: PubMed 37673452Keast T, McErlane J, Kearns R, McKinlay S, Raju I, Watson M, Robertson KE, Berry C, Greenlaw N, Ackland G, McCall P, Shelley B. Study protocol for IMPRoVE: a multicentre prospective observational cohort study of the incidence, impact and mechanisms of perioperative right ventricular dysfunction in non-cardiac surgery. BMJ Open. 2023 Sep 6;13(9):e074687. doi: 10.1136/bmjopen-2023-074687.
- 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.
Ben Shelley principal investigator
National Waiting Times Centre Board
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Right Ventricular Dysfunction, run by NHS National Waiting Times Centre Board at 3 sites in United Kingdom.
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 9 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: status not confirmed, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ben Shelley (0141 951 5000, Benjamin.Shelley@glasgow.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative Right ventricular dysfunction (RVD) (time frame: Echocardiography performed preoperatively and at day 2-4 postoperatively to measure change in RV function). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05827315, which also lists 1 linked publication.
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 25 Apr 2023.