Transplant, HeartHeartRenewalNCT05521399
Heart Transplantation - Renewal
An observational study of Transplant, Heart and Magnetic Resonance Imaging, run by Northwestern University at 2 sites in United States.
Trial summary
Heart transplantation (HTx) is a well-established life-saving procedure but is associated with severe complications. Regular monitoring of heart transplant recipients is thus important for the early detection of these complications. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Transplant, Heart, Magnetic Resonance Imaging
- What is being tested?
- MRI Sequencing, MRI Testing (pediatric) and MRI Testing
- How many people
- 247 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Nov 2021to 31 Jan 2030
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study population includes pediatric and non-pediatric healthy volunteers; as well as, non-pediatric and pediatric heart transplant patients.
Who may be able to join
- At Northwestern University:
- At least 18 years of age
- Able to complete the MR safety screening form as required by SOC
- Able to comprehend and provide informed consent
- Adult Heart Transplant patients scanned at CTI
- -Baseline cardiac MRI prior to 4/2017
Show all 14Show fewer
- Pediatric controls scanned at Lurie
- All ages
- No known CHD
- Receiving clinical cardiac MRI: Some pediatric patients are scheduled to receive cardiac -MRI's to rule out congenital heart disease. In some instances, the outcome is normal - these patients would be considered healthy controls. Pediatric controls are getting MRI scans of heart only.
- Pediatric heart transplant patients scanned at Lurie
- All ages
- Receiving baseline clinical cardiac MRI
- Past heart Tx
Who cannot join
- Abnormal kidney function (eGFR < 30 mL/min/). Patients with a history of kidney problems (GFR < 30 ml/min) or have had a kidney and/or liver transplant will be excluded from the study or may undergo the MRI exam without the use of a contrast agent, per standard MR exclusion criteria
- Contraindication to MRI i.e. device implants, metal hardware, etc as determined by staff technologists
- Adults unable to consent
- Pediatric heart transplant patients scanned at Lurie
- Patients who have not received a heart transplant
- Patients who have not received a cardiac MRI at baseline
- Individuals not receiving the supplemental 10-minute scan, due to GA concerns, will be counted towards the desired study population.
- If a scan returns with an abnormality, they would no longer be considered control and would not be counted towards the desired study population. It is not until the exam is completed the data may be able to determine whether a patient will qualify as a control. Ordering providers routinely order MRI exams to rule out a certain abnormality. This is similar to ordering providers to request a brain MRI if a patient presents with certain symptoms, such as a headache, to rule out a brain tumor. In many cases those exams may return unremarkable.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Northwestern University- Feinberg School of Medicine
Chicago, Illinois, 60611
Emily Powell, 312-695-2956, emily.powell@northwestern.edu
Michael Markl, PhD
- Recruiting
The Ann & Robert Lurie Children's Hospital
Chicago, Illinois, 60611
Pooja Narayan, MS, pnarayan@luriechildrens.org
Cynthia K Rugsby, MD
About this study
Official title: Comprehensive Cardiac Structure-Function Analysis in Heart Transplantation - Renewal
Heart transplantation (HTx) is a well-established life-saving procedure but is associated with severe complications. Regular monitoring of heart transplant recipients is thus important for the early detection of these complications. Current standard clinical tests, however, rely on frequent invasive procedures including endomyocardial biopsies (EMB) and catheter angiography (Cath). In addition, these standard tests are limited by sampling error, the diffuse nature of HTx complications, and high health care utilization cost, estimated at >$150,000 per year per patient in the US. To address these limitations, our group has developed a non-invasive multiparametric cardiac MRI, which can quantify abnormal changes in heart tissue and function. Our efforts during the initial period of this study (NIH funded 2014-2019) have focused on the two major complications of HTx: 1) acute cardiac rejection (ACR), the leading cause of death in the first year after heart transplant; and 2) cardiac allograft vasculopathy (CAV), the greatest risk factor for 5-year mortality beyond the first year after heart transplantation. For these major compilation, our previous cardiac MRI studies have identified new non-invasive cardiac MRI measures that can detect abnormalities of heart tissue and function. In addition, the data was able to show that heart donor and recipient mismatch (age, sex, height, weight, etc.) can cause changes in tissue and function of the transplanted heart.
Read the detailed description
Aim 1:
To develop dedicated multiparametric cardiac MRI protocols that account for wide range body sizes and patient physiology (e.g., heart rates, breathing patterns) of heart transplant recipients, critical for the wide age range in HTx from pediatric to adult. Second, to facilitate clinical translation and multi-site portability of the often time-consuming data analysis methodology, the development of artificial intelligence (AI) deep learning concepts to enable automated cardiac MRI analysis across large cohorts. The hypothesis to be tested will verify that automated AI analysis can detect altered cardiac MRI metrics with improved efficiency and reduced inter-rater variability
Aim 2:
Comprehensive cardiac MRI measures will be evaluated for the identification of complications after heart transplantation (ACR, CAV) in children. The anticipated enrollment of n=80 (20 per year) pediatric HTx patients (<21 years) in years 2-5 at Lurie Children's Hospital. Inclusion criteria include a clinically indicated routine cardiac MRI for HTx graft surveillance. The hypothesis to be tested is that cardiac MRI measures can inform pediatric donor selection by providing important new data on the impact of donor-recipient mismatch (e.g. age, sex, heart size, etc.) on changes in tissue and function of the transplanted heart.
Aim 3:
The slow progression of complications in heart transplant recipients requires a long-term (>5-year) follow-up study to determine the diagnostic value of cardiac MRI for the detection of patient outcomes. Cardiac MRI data will be collected at long-term (>5-year) follow-up in 80 HTx recipients who have already received their baseline cardiac MRI during the initial NIH-funded study period (2014-2019). will study the diagnostic value of cardiac MRI to improve the monitoring of heart transplant recipients for the major complications of acute cardiac rejection (ACR) and cardiac allograft vasculopathy (CAV). The anticipated follow-up enrollment of a total of 80 HTx patients during years 2-5 with a minimum of 5-year follow-up (20 HTx patients/year returning for HTx surveillance, baseline MRI scan was performed during the initial funding period. To clarify, our aim isn't to perfectly match donor-recipient but rather to study the clinical implications of mismatch and to help define the threshold for "too much" mismatch. In other words, today the human body may sometimes not accept a heart if the mismatch will be too great, this is sometimes hard to do and literature is scarce, especially in terms of functional rather than anatomic implications. The goal of the study could better inform these decisions.
- Conditions
- Transplant, Heart, Magnetic Resonance Imaging
- Being tested
- MRI Sequencing, MRI Testing (pediatric), MRI Testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI SequencingDiagnostic test
MRI test-retest (select healthy volunteers) for development of MRI sequence.
MRI Testing (pediatric)Diagnostic test
Comprehensive cardiac MRI measures will be evaluated for the identification of complications after heart transplantation (ACR, CAV) in children.
MRI TestingDiagnostic test
Cardiac MRI to improve HTx monitoring for ACR and CAV as well as outcome prediction
| Study group | Role | What they receive |
|---|---|---|
| Aim#1 Development | Developing dedicated multiparametric cardiac MRI protocols that account for a wide range of body sizes and patient physiology (e.g., heart rates, breathing patterns) of heart transplant recipients, is critical for the wide age range in HTx from pediatric to adult. Second, to facilitate clinical translation and multi-site portability of the often time-consuming data analysis. Methodology, to be employed and developed artificial intelligence (AI) deep learning concepts to enable automated cardiac MRI analysis across large cohorts. The hypothesis to be tested is that automated AI analysis can detect altered cardiac MRI metrics with improved efficiency and reduced inter-rater variability Receives: Diagnostic Test: MRI Sequencing | |
| Aim#2 Cardiac MRI in Pediatric HTx & Donor-Recipient Mismatch | Comprehensive cardiac MRI measures will be evaluated for the identification of complications after heart transplantation (ACR, CAV) in children. The anticipated enrollment of n=80 (20 per year) pediatric HTx patients (<21 years) in years 2-5 at Lurie Children's Hospital. Inclusion criteria include a clinically indicated routine cardiac MRI for HTx graft surveillance. The hypothesis to be tested is that cardiac MRI measures can inform pediatric donor selection by providing important new data on the impact of donor-recipient mismatch (e.g. age, sex, heart size, etc.) on changes in tissue and function of the transplanted heart. Receives: Diagnostic Test: MRI Testing (pediatric) | |
| Aim#3 Longitudinal patient outcome study | The study will research the diagnostic value of cardiac MRI to improve the monitoring of heart transplant recipients for the major complications of acute cardiac rejection (ACR) and cardiac allograft vasculopathy (CAV). The anticipated follow-up enrollment of a total of 80 HTx patients during years 2-5 with a minimum of 5-year follow-up (20 HTx patients/year returning for HTx surveillance, baseline MRI scan was performed during the initial funding period. To clarify, our aim isn't to perfectly match donor-recipient but rather to study the clinical implications of mismatch and to help define the threshold for "too much" mismatch. In other words, today human beings sometimes don't accept a heart if the mismatch will be too great, this is sometimes hard to do and literature is scarce, especially in terms of functional rather than anatomic implications. Our goal is that this study could better inform these decisions. Receives: Diagnostic Test: MRI Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and severity of acute rejection (ACR) episodes at follow up, quantified by ACR grade (1R, 2R, 3R)
Long-term Follow-Up (> 5 years) will determine the prognostic value for cardiac MRI metrics (T2, T1, LV, and RV volumes, cardiac strain, myocardial fibrosis) for graft complications as defined by the number of acute rejection (ACR) episodes, ACR grade (1R, 2R, 3R)
Measured: 4 years
Severity of cardiac allograft vasculopathy (CAV) at follow-up, quantified by CAV grade (0,1,2,3)
Long-term Follow-Up (> 5 years) will determine the prognostic value for cardiac MRI metrics (T2, T1, LV, and RV volumes, cardiac strain, myocardial fibrosis) for graft complications as defined by ardiac allograft vasculopathy (CAV) grade (0,1,2)
Measured: 4 years
Secondary outcomes (1)
Adverse outcome at follow-up, defined by hospitalization (yes/no), nonfatal myocardial infarction (yes/no), coronary revascularization (yes/no), re-transplantation (yes/no), death (yes/no)
Long-term Follow-Up (> 5 years) will determine the prognostic value for cardiac MRI metrics (T2, T1, LV and RV volumes, cardiac strain, myocardial fibrosis) for adverse patient outcomes as defined by determinants graft failure, hospitalization, nonfatal myocardial infarction, coronary revascularization, re-transplantation, death.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2022
- Study start19 Nov 2021
- Primary completionApr 2027 (estimated)
- Study completion31 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplant, HeartStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- 247 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Michael Markl, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05521399
- Sponsor's protocol ID
- STU00215237
- Acronym
- HeartRenewal
- Status last verified
- Mar 2026
- First submitted
- 26 Jul 2022
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Cardiac Structure-Function Analysis in Heart Transplantation - Renewal
- ClinicalTrials.gov ID
- NCT05521399
- Acronym / sponsor ID
- HeartRenewal / STU00215237
- Conditions
- Transplant, Heart, Magnetic Resonance Imaging
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 247 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 19 Nov 2021 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- 31 Jan 2030 (estimated)
- First posted
- 30 Aug 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.
Heart transplantation (HTx) is a well-established life-saving procedure but is associated with severe complications. Regular monitoring of heart transplant recipients is thus important for the early detection of these complications. Current standard clinical tests, however, rely on frequent invasive procedures including endomyocardial biopsies (EMB) and catheter angiography (Cath). In addition, these standard tests are limited by sampling error, the diffuse nature of HTx complications, and high health care utilization cost, estimated at >$150,000 per year per patient in the US. To address these limitations, our group has developed a non-invasive multiparametric cardiac MRI, which can quantify abnormal changes in heart tissue and function. Our efforts during the initial period of this study (NIH funded 2014-2019) have focused on the two major complications of HTx: 1) acute cardiac rejection (ACR), the leading cause of death in the first year after heart transplant; and 2) cardiac allograft vasculopathy (CAV), the greatest risk factor for 5-year mortality beyond the first year after heart transplantation. For these major compilation, our previous cardiac MRI studies have identified new non-invasive cardiac MRI measures that can detect abnormalities of heart tissue and function. In addition, the data was able to show that heart donor and recipient mismatch (age, sex, height, weight, etc.) can cause changes in tissue and function of the transplanted heart.
Detailed description
Aim 1:
To develop dedicated multiparametric cardiac MRI protocols that account for wide range body sizes and patient physiology (e.g., heart rates, breathing patterns) of heart transplant recipients, critical for the wide age range in HTx from pediatric to adult. Second, to facilitate clinical translation and multi-site portability of the often time-consuming data analysis methodology, the development of artificial intelligence (AI) deep learning concepts to enable automated cardiac MRI analysis across large cohorts. The hypothesis to be tested will verify that automated AI analysis can detect altered cardiac MRI metrics with improved efficiency and reduced inter-rater variability
Aim 2:
Comprehensive cardiac MRI measures will be evaluated for the identification of complications after heart transplantation (ACR, CAV) in children. The anticipated enrollment of n=80 (20 per year) pediatric HTx patients (<21 years) in years 2-5 at Lurie Children's Hospital. Inclusion criteria include a clinically indicated routine cardiac MRI for HTx graft surveillance. The hypothesis to be tested is that cardiac MRI measures can inform pediatric donor selection by providing important new data on the impact of donor-recipient mismatch (e.g. age, sex, heart size, etc.) on changes in tissue and function of the transplanted heart.
Aim 3:
The slow progression of complications in heart transplant recipients requires a long-term (>5-year) follow-up study to determine the diagnostic value of cardiac MRI for the detection of patient outcomes. Cardiac MRI data will be collected at long-term (>5-year) follow-up in 80 HTx recipients who have already received their baseline cardiac MRI during the initial NIH-funded study period (2014-2019). will study the diagnostic value of cardiac MRI to improve the monitoring of heart transplant recipients for the major complications of acute cardiac rejection (ACR) and cardiac allograft vasculopathy (CAV). The anticipated follow-up enrollment of a total of 80 HTx patients during years 2-5 with a minimum of 5-year follow-up (20 HTx patients/year returning for HTx surveillance, baseline MRI scan was performed during the initial funding period. To clarify, our aim isn't to perfectly match donor-recipient but rather to study the clinical implications of mismatch and to help define the threshold for "too much" mismatch. In other words, today the human body may sometimes not accept a heart if the mismatch will be too great, this is sometimes hard to do and literature is scarce, especially in terms of functional rather than anatomic implications. The goal of the study could better inform these decisions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aim#1 Development | – | Diagnostic Test: MRI SequencingDeveloping dedicated multiparametric cardiac MRI protocols that account for a wide range of body sizes and patient physiology (e.g., heart rates, breathing patterns) of heart transplant recipients, is critical for the wide age range in HTx from pediatric to adult. Second, to facilitate clinical translation and multi-site portability of the often time-consuming data analysis. Methodology, to be employed and developed artificial intelligence (AI) deep learning concepts to enable automated cardiac MRI analysis across large cohorts. The hypothesis to be tested is that automated AI analysis can detect altered cardiac MRI metrics with improved efficiency and reduced inter-rater variability |
| Aim#2 Cardiac MRI in Pediatric HTx & Donor-Recipient Mismatch | – | Diagnostic Test: MRI Testing (pediatric)Comprehensive cardiac MRI measures will be evaluated for the identification of complications after heart transplantation (ACR, CAV) in children. The anticipated enrollment of n=80 (20 per year) pediatric HTx patients (<21 years) in years 2-5 at Lurie Children's Hospital. Inclusion criteria include a clinically indicated routine cardiac MRI for HTx graft surveillance. The hypothesis to be tested is that cardiac MRI measures can inform pediatric donor selection by providing important new data on the impact of donor-recipient mismatch (e.g. age, sex, heart size, etc.) on changes in tissue and function of the transplanted heart. |
| Aim#3 Longitudinal patient outcome study | – | Diagnostic Test: MRI TestingThe study will research the diagnostic value of cardiac MRI to improve the monitoring of heart transplant recipients for the major complications of acute cardiac rejection (ACR) and cardiac allograft vasculopathy (CAV). The anticipated follow-up enrollment of a total of 80 HTx patients during years 2-5 with a minimum of 5-year follow-up (20 HTx patients/year returning for HTx surveillance, baseline MRI scan was performed during the initial funding period. To clarify, our aim isn't to perfectly match donor-recipient but rather to study the clinical implications of mismatch and to help define the threshold for "too much" mismatch. In other words, today human beings sometimes don't accept a heart if the mismatch will be too great, this is sometimes hard to do and literature is scarce, especially in terms of functional rather than anatomic implications. Our goal is that this study could better inform these decisions. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population includes pediatric and non-pediatric healthy volunteers; as well as, non-pediatric and pediatric heart transplant patients.
Key inclusion criteria (14 listed)
- At least 18 years of age
- Able to complete the MR safety screening form as required by SOC
- Able to comprehend and provide informed consent
- Adult Heart Transplant patients scanned at CTI
- -Baseline cardiac MRI prior to 4/2017
Key exclusion criteria (8 listed)
- Abnormal kidney function (eGFR < 30 mL/min/). Patients with a history of kidney problems (GFR < 30 ml/min) or have had a kidney and/or liver transplant will be excluded from the study or may undergo the MRI exam without the use of a contrast agent, per standard MR exclusion criteria
- Contraindication to MRI i.e. device implants, metal hardware, etc as determined by staff technologists
- Adults unable to consent
- Pediatric heart transplant patients scanned at Lurie
- Patients who have not received a heart transplant
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 |
|---|---|---|
| MRI SequencingMRI test-retest (select healthy volunteers) for development of MRI sequence. | Diagnostic test | Aim#1 Development |
| MRI Testing (pediatric)Comprehensive cardiac MRI measures will be evaluated for the identification of complications after heart transplantation (ACR, CAV) in children. | Diagnostic test | Aim#2 Cardiac MRI in Pediatric HTx & Donor-Recipient Mismatch |
| MRI TestingCardiac MRI to improve HTx monitoring for ACR and CAV as well as outcome prediction | Diagnostic test | Aim#3 Longitudinal patient outcome study |
Primary outcome
Number and severity of acute rejection (ACR) episodes at follow up, quantified by ACR grade (1R, 2R, 3R)
Time frame: 4 years
Long-term Follow-Up (> 5 years) will determine the prognostic value for cardiac MRI metrics (T2, T1, LV, and RV volumes, cardiac strain, myocardial fibrosis) for graft complications as defined by the number of acute rejection (ACR) episodes, ACR grade (1R, 2R, 3R)
Severity of cardiac allograft vasculopathy (CAV) at follow-up, quantified by CAV grade (0,1,2,3)
Time frame: 4 years
Long-term Follow-Up (> 5 years) will determine the prognostic value for cardiac MRI metrics (T2, T1, LV, and RV volumes, cardiac strain, myocardial fibrosis) for graft complications as defined by ardiac allograft vasculopathy (CAV) grade (0,1,2)
1 secondary outcome
Adverse outcome at follow-up, defined by hospitalization (yes/no), nonfatal myocardial infarction (yes/no), coronary revascularization (yes/no), re-transplantation (yes/no), death (yes/no)
Time frame: 4 years
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 24 Mar 2026.
Related trials for Transplant, Heart
Active, not recruiting
Heart Failure Patient Management and Interventions Using Continuous Patient Monitoring Outside Hospitals and Real-world Data
Chronic Heart Failure, Heart Transplant Recipient
Not yet recruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
RecruitingObservational study
Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors
Testicular Cancer, Survivorship
Not yet recruiting
Molecular Evidence of Rejection Intervention Trial
Heart Transplant Rejection
Recruiting
A Home-Based Exercise Intervention (CAREFit-BMT) in Improving Heart Function Among Patients With High Risk Acute Myeloid Leukemia Undergoing Stem Cell Transplant
Acute Myeloid Leukemia
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transplant, Heart and Magnetic Resonance Imaging, run by Northwestern University at 2 sites in United States.
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 14 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 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 Emily Powell (3126952956, emily.powell@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and severity of acute rejection (ACR) episodes at follow up, quantified by ACR grade (1R, 2R, 3R) (time frame: 4 years). 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?
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 24 Mar 2026.