Heart FailureNCT05376254
3D Assessment of RV Function in Patients Undergoing LVAD Implantation
An observational study of Heart Failure, run by University of Alberta at 1 site in Canada.
Trial summary
This goal of this study is to analyze images of the right ventricle taken via 3D transesophageal echocardiography (TEE) during left ventricular assist device (LVAD) implantation. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- 22 Mar 2022to 19 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All patients coming for left ventricular assist device implantation.
Who may be able to join
- Patients will be eligible to be included in the study if they receive either a left-sided:
- HeartMate III (Thoratec, Pleasanton, CA)
- HeartWare HVAD (HeartWare, Oakville CA)
- Levitronix CentriMag (Levitronix LLC, Waltham, MA) LVAD.
Who cannot join
- Patients will be excluded if::
- hemodynamic data needed to calculate PAPi or comprehensive echocardiographic images are missing
- additional procedures affecting cardiac geometry and/or hemodynamic measurements, such as tricuspid, mitral, and/or aortic valve repair/replacement, were performed at the time of LVAD implantation
- sternal closure at the end of the procedure is not possible
- RV mechanical support was introduced concurrently with LVAD implantation
- inadequate image quality required to obtain a 3D protocol
- known contraindication to TEE
- unexpected inability to advance probe into the mid-esophagus
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Mazankowski Alberta Heart Institute
Edmonton, Alberta, T6G 2B7
Surita Sidhu, MD, 780-407-8861, surita@ualberta.ca
About this study
Official title: Three-Dimensional Assessment of Right Ventricular Function in Patients Undergoing Left Ventricular Assist Device Implantation
This goal of this study is to analyze images of the right ventricle taken via 3D transesophageal echocardiography (TEE) during left ventricular assist device (LVAD) implantation.
Read the detailed description
There are two chambers in the heart known as ventricles which are responsible for pumping blood to both the lungs and the rest of the body. The right ventricle pumps blood to the lungs for oxygenation. The left ventricle then delivers this oxygenated blood to the organs in the body. When the left ventricle is damaged enough that it is not able to effectively pump blood then it may be necessary to assist it with a mechanical pump. This pump is called left ventricular assist device (LVAD).
Left ventricular assist devices (LVADs) improve quality of life and survival in patients with end stage heart failure. However, right ventricular (RV) failure is common in 20-50% of LVAD recipients and is associated with perioperative complications.
Traditional two-dimensional ultrasound views of the right ventricle may not accurately depict how well or poorly the right ventricle is working. Three-dimensional (3D) images can overcome the limitations of two-dimensional images and are becoming more commonplace. This goal of this study is to analyze images of the right ventricle taken via 3D transesophageal echocardiography (TEE) during the LVAD implantation to help predict which patients are at higher risk of right ventricular failure within 14 days of the procedure.
- Conditions
- Heart Failure
- Keywords
- Right Ventricular Function, Left Ventricular Assist Device, 3D transesophageal echocardiography
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular strain
Prognostic indicator of hypertensive heart failure
Measured: 24 hours
Right ventricular fractional area of change
Percentage change in the RV chamber area between end-diastole to end-systole
Measured: 24 hours
Right ventricular free wall strain
Prognostic indicator of pulmonary arterial hypertension
Measured: 24 hours
Right ventricular end diastolic volume
Amount of blood in the heart's right ventricle just before the heart contracts
Measured: 24 hours
Light ventricular end diastolic volume
Amount of blood in the heart's left ventricle just before the heart contracts
Measured: 24 hours
Right ventricular end systolic volume
Amount of blood in the heart's right ventricle just after the heart contracts
Measured: 24 hours
Left ventricular end systolic volume
Amount of blood in the heart's left ventricle just after the heart contracts
Measured: 24 hours
Right ventricular ejection fraction
Amount of blood being pumped out of the right ventricle each time it contracts.
Measured: 24 hours
Left ventricular ejection fraction
Amount of blood being pumped out of the left ventricle each time it contracts.
Measured: 24 hours
Tricuspid annular plane systolic excursion
Parameter of global right ventricular function
Measured: 24 hours
Secondary outcomes (11)
Age
Demographic measure
Measured: 1 day
Gender
Demographic measure
Measured: 1 day
Body Surface Area
Demographic measure
Measured: 1 day
Central venous pressure
Pressure in the thoracic vena cava near the right atrium
Measured: 14 days
Pulmonary artery pulsatility index
Hemodynamic index
Measured: 14 days
Need for right ventricular mechanical support
Circulatory support
Measured: 14 days
Need for pulmonary vasodilators
Supportive medication
Measured: 14 days
Need for vasopressors
Supportive medications
Measured: 14 days
Aspartate aminotransferase
Lab test (> or qual to 80 IU/L)
Measured: 14 days
Bilirubin
Lab test (> 2.0 mg/dL)
Measured: 14 days
Creatinine
Lab test (> or equal to 2.3 mg/dL)
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start22 Mar 2022
- Primary completion19 Jan 2027 (estimated)
- Study completion19 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Surita Sidhu, MD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05376254
- Sponsor's protocol ID
- Pro00112239
- Status last verified
- May 2026
- First submitted
- 27 Jan 2022
- Last updated
- 29 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Towheed A, Sabbagh E, Gupta R, Assiri S, Chowdhury MA, Moukarbel GV, Khuder SA, Schwann TA, Bonnell MR, Cooper CJ, Khouri S. Right Ventricular Dysfunction and Short-Term Outcomes Following Left-Sided Valvular Surgery: An Echocardiographic Study. J Am Heart Assoc. 2021 Feb 16;10(4):e016283. doi: 10.1161/JAHA.120.016283. Epub 2021 Feb 9.
PubMed 33559474Amzulescu MS, De Craene M, Langet H, Pasquet A, Vancraeynest D, Pouleur AC, Vanoverschelde JL, Gerber BL. Myocardial strain imaging: review of general principles, validation, and sources of discrepancies. Eur Heart J Cardiovasc Imaging. 2019 Jun 1;20(6):605-619. doi: 10.1093/ehjci/jez041.
PubMed 30903139Friedberg MK, Redington AN. Right versus left ventricular failure: differences, similarities, and interactions. Circulation. 2014 Mar 4;129(9):1033-44. doi: 10.1161/CIRCULATIONAHA.113.001375. No abstract available.
PubMed 24589696Amsallem M, Mercier O, Kobayashi Y, Moneghetti K, Haddad F. Forgotten No More: A Focused Update on the Right Ventricle in Cardiovascular Disease. JACC Heart Fail. 2018 Nov;6(11):891-903. doi: 10.1016/j.jchf.2018.05.022. Epub 2018 Oct 10.
PubMed 30316939Konstam MA, Kiernan MS, Bernstein D, Bozkurt B, Jacob M, Kapur NK, Kociol RD, Lewis EF, Mehra MR, Pagani FD, Raval AN, Ward C; American Heart Association Council on Clinical Cardiology; Council on Cardiovascular Disease in the Young; and Council on Cardiovascular Surgery and Anesthesia. Evaluation and Management of Right-Sided Heart Failure: A Scientific Statement From the American Heart Association. Circulation. 2018 May 15;137(20):e578-e622. doi: 10.1161/CIR.0000000000000560. Epub 2018 Apr 12.
PubMed 29650544Costanzo MR, Dipchand A, Starling R, Anderson A, Chan M, Desai S, Fedson S, Fisher P, Gonzales-Stawinski G, Martinelli L, McGiffin D, Smith J, Taylor D, Meiser B, Webber S, Baran D, Carboni M, Dengler T, Feldman D, Frigerio M, Kfoury A, Kim D, Kobashigawa J, Shullo M, Stehlik J, Teuteberg J, Uber P, Zuckermann A, Hunt S, Burch M, Bhat G, Canter C, Chinnock R, Crespo-Leiro M, Delgado R, Dobbels F, Grady K, Kao W, Lamour J, Parry G, Patel J, Pini D, Towbin J, Wolfel G, Delgado D, Eisen H, Goldberg L, Hosenpud J, Johnson M, Keogh A, Lewis C, O'Connell J, Rogers J, Ross H, Russell S, Vanhaecke J; International Society of Heart and Lung Transplantation Guidelines. The International Society of Heart and Lung Transplantation Guidelines for the care of heart transplant recipients. J Heart Lung Transplant. 2010 Aug;29(8):914-56. doi: 10.1016/j.healun.2010.05.034. No abstract available.
PubMed 20643330Magunia H, Dietrich C, Langer HF, Schibilsky D, Schlensak C, Rosenberger P, Nowak-Machen M. 3D echocardiography derived right ventricular function is associated with right ventricular failure and mid-term survival after left ventricular assist device implantation. Int J Cardiol. 2018 Dec 1;272:348-355. doi: 10.1016/j.ijcard.2018.06.026. Epub 2018 Jun 8.
PubMed 29903518Haddad F, Doyle R, Murphy DJ, Hunt SA. Right ventricular function in cardiovascular disease, part II: pathophysiology, clinical importance, and management of right ventricular failure. Circulation. 2008 Apr 1;117(13):1717-31. doi: 10.1161/CIRCULATIONAHA.107.653584. No abstract available.
PubMed 18378625Lella LK, Sales VL, Goldsmith Y, Chan J, Iskandir M, Gulkarov I, Tortolani A, Brener SJ, Sacchi TJ, Heitner JF. Reduced Right Ventricular Function Predicts Long-Term Cardiac Re-Hospitalization after Cardiac Surgery. PLoS One. 2015 Jul 21;10(7):e0132808. doi: 10.1371/journal.pone.0132808. eCollection 2015.
PubMed 26197273Nagata Y, Wu VC, Kado Y, Otani K, Lin FC, Otsuji Y, Negishi K, Takeuchi M. Prognostic Value of Right Ventricular Ejection Fraction Assessed by Transthoracic 3D Echocardiography. Circ Cardiovasc Imaging. 2017 Feb;10(2):e005384. doi: 10.1161/CIRCIMAGING.116.005384.
PubMed 28174197Rudski LG, Lai WW, Afilalo J, Hua L, Handschumacher MD, Chandrasekaran K, Solomon SD, Louie EK, Schiller NB. Guidelines for the echocardiographic assessment of the right heart in adults: a report from the American Society of Echocardiography endorsed by the European Association of Echocardiography, a registered branch of the European Society of Cardiology, and the Canadian Society of Echocardiography. J Am Soc Echocardiogr. 2010 Jul;23(7):685-713; quiz 786-8. doi: 10.1016/j.echo.2010.05.010. No abstract available.
PubMed 20620859Schneider M, Binder T. Echocardiographic evaluation of the right heart. Wien Klin Wochenschr. 2018 Jul;130(13-14):413-420. doi: 10.1007/s00508-018-1330-3. Epub 2018 Mar 19.
PubMed 29556779Mogelvang J, Stubgaard M, Thomsen C, Henriksen O. Evaluation of right ventricular volumes measured by magnetic resonance imaging. Eur Heart J. 1988 May;9(5):529-33. doi: 10.1093/oxfordjournals.eurheartj.a062539.
PubMed 3402468Dragulescu A, Grosse-Wortmann L, Fackoury C, Mertens L. Echocardiographic assessment of right ventricular volumes: a comparison of different techniques in children after surgical repair of tetralogy of Fallot. Eur Heart J Cardiovasc Imaging. 2012 Jul;13(7):596-604. doi: 10.1093/ejechocard/jer278. Epub 2011 Dec 22.
PubMed 22194094Niemann PS, Pinho L, Balbach T, Galuschky C, Blankenhagen M, Silberbach M, Broberg C, Jerosch-Herold M, Sahn DJ. Anatomically oriented right ventricular volume measurements with dynamic three-dimensional echocardiography validated by 3-Tesla magnetic resonance imaging. J Am Coll Cardiol. 2007 Oct 23;50(17):1668-76. doi: 10.1016/j.jacc.2007.07.031.
PubMed 17950149
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three-Dimensional Assessment of Right Ventricular Function in Patients Undergoing Left Ventricular Assist Device Implantation
- ClinicalTrials.gov ID
- NCT05376254
- Acronym / sponsor ID
- Pro00112239
- Conditions
- Heart Failure
- Keywords
- Right Ventricular Function, Left Ventricular Assist Device, 3D transesophageal echocardiography
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 22 Mar 2022 (actual)
- Primary completion
- 19 Jan 2027 (estimated)
- Study completion
- 19 Jan 2027 (estimated)
- First posted
- 17 May 2022 (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 goal of this study is to analyze images of the right ventricle taken via 3D transesophageal echocardiography (TEE) during left ventricular assist device (LVAD) implantation.
Detailed description
There are two chambers in the heart known as ventricles which are responsible for pumping blood to both the lungs and the rest of the body. The right ventricle pumps blood to the lungs for oxygenation. The left ventricle then delivers this oxygenated blood to the organs in the body. When the left ventricle is damaged enough that it is not able to effectively pump blood then it may be necessary to assist it with a mechanical pump. This pump is called left ventricular assist device (LVAD).
Left ventricular assist devices (LVADs) improve quality of life and survival in patients with end stage heart failure. However, right ventricular (RV) failure is common in 20-50% of LVAD recipients and is associated with perioperative complications.
Traditional two-dimensional ultrasound views of the right ventricle may not accurately depict how well or poorly the right ventricle is working. Three-dimensional (3D) images can overcome the limitations of two-dimensional images and are becoming more commonplace. This goal of this study is to analyze images of the right ventricle taken via 3D transesophageal echocardiography (TEE) during the LVAD implantation to help predict which patients are at higher risk of right ventricular failure within 14 days of the procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients coming for left ventricular assist device implantation.
Key inclusion criteria (4 listed)
- Patients will be eligible to be included in the study if they receive either a left-sided:
Key exclusion criteria (8 listed)
- Patients will be excluded if::
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Left ventricular strain
Time frame: 24 hours
Prognostic indicator of hypertensive heart failure
Right ventricular fractional area of change
Time frame: 24 hours
Percentage change in the RV chamber area between end-diastole to end-systole
Right ventricular free wall strain
Time frame: 24 hours
Prognostic indicator of pulmonary arterial hypertension
Right ventricular end diastolic volume
Time frame: 24 hours
Amount of blood in the heart's right ventricle just before the heart contracts
Light ventricular end diastolic volume
Time frame: 24 hours
Amount of blood in the heart's left ventricle just before the heart contracts
Right ventricular end systolic volume
Time frame: 24 hours
Amount of blood in the heart's right ventricle just after the heart contracts
Left ventricular end systolic volume
Time frame: 24 hours
Amount of blood in the heart's left ventricle just after the heart contracts
Right ventricular ejection fraction
Time frame: 24 hours
Amount of blood being pumped out of the right ventricle each time it contracts.
Left ventricular ejection fraction
Time frame: 24 hours
Amount of blood being pumped out of the left ventricle each time it contracts.
Tricuspid annular plane systolic excursion
Time frame: 24 hours
Parameter of global right ventricular function
11 secondary outcomes
Age
Time frame: 1 day
Gender
Time frame: 1 day
Body Surface Area
Time frame: 1 day
Central venous pressure
Time frame: 14 days
Pulmonary artery pulsatility index
Time frame: 14 days
Need for right ventricular mechanical support
Time frame: 14 days
Need for pulmonary vasodilators
Time frame: 14 days
Need for vasopressors
Time frame: 14 days
Aspartate aminotransferase
Time frame: 14 days
Bilirubin
Time frame: 14 days
Creatinine
Time frame: 14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Background: PubMed 33559474Towheed A, Sabbagh E, Gupta R, Assiri S, Chowdhury MA, Moukarbel GV, Khuder SA, Schwann TA, Bonnell MR, Cooper CJ, Khouri S. Right Ventricular Dysfunction and Short-Term Outcomes Following Left-Sided Valvular Surgery: An Echocardiographic Study. J Am Heart Assoc. 2021 Feb 16;10(4):e016283. doi: 10.1161/JAHA.120.016283. Epub 2021 Feb 9.
- Background: PubMed 30903139Amzulescu MS, De Craene M, Langet H, Pasquet A, Vancraeynest D, Pouleur AC, Vanoverschelde JL, Gerber BL. Myocardial strain imaging: review of general principles, validation, and sources of discrepancies. Eur Heart J Cardiovasc Imaging. 2019 Jun 1;20(6):605-619. doi: 10.1093/ehjci/jez041.
- Background: PubMed 24589696Friedberg MK, Redington AN. Right versus left ventricular failure: differences, similarities, and interactions. Circulation. 2014 Mar 4;129(9):1033-44. doi: 10.1161/CIRCULATIONAHA.113.001375. No abstract available.
- Background: PubMed 30316939Amsallem M, Mercier O, Kobayashi Y, Moneghetti K, Haddad F. Forgotten No More: A Focused Update on the Right Ventricle in Cardiovascular Disease. JACC Heart Fail. 2018 Nov;6(11):891-903. doi: 10.1016/j.jchf.2018.05.022. Epub 2018 Oct 10.
- Background: PubMed 29650544Konstam MA, Kiernan MS, Bernstein D, Bozkurt B, Jacob M, Kapur NK, Kociol RD, Lewis EF, Mehra MR, Pagani FD, Raval AN, Ward C; American Heart Association Council on Clinical Cardiology; Council on Cardiovascular Disease in the Young; and Council on Cardiovascular Surgery and Anesthesia. Evaluation and Management of Right-Sided Heart Failure: A Scientific Statement From the American Heart Association. Circulation. 2018 May 15;137(20):e578-e622. doi: 10.1161/CIR.0000000000000560. Epub 2018 Apr 12.
- Background: PubMed 20643330Costanzo MR, Dipchand A, Starling R, Anderson A, Chan M, Desai S, Fedson S, Fisher P, Gonzales-Stawinski G, Martinelli L, McGiffin D, Smith J, Taylor D, Meiser B, Webber S, Baran D, Carboni M, Dengler T, Feldman D, Frigerio M, Kfoury A, Kim D, Kobashigawa J, Shullo M, Stehlik J, Teuteberg J, Uber P, Zuckermann A, Hunt S, Burch M, Bhat G, Canter C, Chinnock R, Crespo-Leiro M, Delgado R, Dobbels F, Grady K, Kao W, Lamour J, Parry G, Patel J, Pini D, Towbin J, Wolfel G, Delgado D, Eisen H, Goldberg L, Hosenpud J, Johnson M, Keogh A, Lewis C, O'Connell J, Rogers J, Ross H, Russell S, Vanhaecke J; International Society of Heart and Lung Transplantation Guidelines. The International Society of Heart and Lung Transplantation Guidelines for the care of heart transplant recipients. J Heart Lung Transplant. 2010 Aug;29(8):914-56. doi: 10.1016/j.healun.2010.05.034. No abstract available.
- Background: PubMed 29903518Magunia H, Dietrich C, Langer HF, Schibilsky D, Schlensak C, Rosenberger P, Nowak-Machen M. 3D echocardiography derived right ventricular function is associated with right ventricular failure and mid-term survival after left ventricular assist device implantation. Int J Cardiol. 2018 Dec 1;272:348-355. doi: 10.1016/j.ijcard.2018.06.026. Epub 2018 Jun 8.
- Background: PubMed 18378625Haddad F, Doyle R, Murphy DJ, Hunt SA. Right ventricular function in cardiovascular disease, part II: pathophysiology, clinical importance, and management of right ventricular failure. Circulation. 2008 Apr 1;117(13):1717-31. doi: 10.1161/CIRCULATIONAHA.107.653584. No abstract available.
- Background: PubMed 26197273Lella LK, Sales VL, Goldsmith Y, Chan J, Iskandir M, Gulkarov I, Tortolani A, Brener SJ, Sacchi TJ, Heitner JF. Reduced Right Ventricular Function Predicts Long-Term Cardiac Re-Hospitalization after Cardiac Surgery. PLoS One. 2015 Jul 21;10(7):e0132808. doi: 10.1371/journal.pone.0132808. eCollection 2015.
- Background: PubMed 28174197Nagata Y, Wu VC, Kado Y, Otani K, Lin FC, Otsuji Y, Negishi K, Takeuchi M. Prognostic Value of Right Ventricular Ejection Fraction Assessed by Transthoracic 3D Echocardiography. Circ Cardiovasc Imaging. 2017 Feb;10(2):e005384. doi: 10.1161/CIRCIMAGING.116.005384.
- Background: PubMed 20620859Rudski LG, Lai WW, Afilalo J, Hua L, Handschumacher MD, Chandrasekaran K, Solomon SD, Louie EK, Schiller NB. Guidelines for the echocardiographic assessment of the right heart in adults: a report from the American Society of Echocardiography endorsed by the European Association of Echocardiography, a registered branch of the European Society of Cardiology, and the Canadian Society of Echocardiography. J Am Soc Echocardiogr. 2010 Jul;23(7):685-713; quiz 786-8. doi: 10.1016/j.echo.2010.05.010. No abstract available.
- Background: PubMed 29556779Schneider M, Binder T. Echocardiographic evaluation of the right heart. Wien Klin Wochenschr. 2018 Jul;130(13-14):413-420. doi: 10.1007/s00508-018-1330-3. Epub 2018 Mar 19.
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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.
Surita Sidhu, MD principal investigator
University of Alberta
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 Heart Failure, run by University of Alberta at 1 site in Canada.
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 4 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: looking for participants now, as of the sponsor's last update on 29 May 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Surita Sidhu, MD (780-407-8861, surita@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular strain (time frame: 24 hours). The study lists 10 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 NCT05376254, which also lists 23 linked publications.
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 29 May 2026.