Diabetes Mellitus, Type 2PREDICTNCT03132129
Prevalence and Determinants of Subclinical Cardiovascular Dysfunction in Adults With Type 2 Diabetes Mellitus
An observational study of Diabetes Mellitus, Type 2 and Diabetic Cardiomyopathies, run by University of Leicester at 1 site in United Kingdom.
Trial summary
Background: Heart failure is a major cause of morbidity and mortality in diabetes mellitus, but its pathophysiology is poorly understood. Aim: To determine the prevalence and determinants of subclinical cardiovascular dysfunction in adults with type 2 diabetes (T2D). Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Diabetic Cardiomyopathies
- What is being tested?
- Cardiovascular magnetic resonance (CMR) imaging and magnetic resonance spectroscopy, Transthoracic echocardiography and Computed tomography coronary artery calcium scoring
- Type of treatment
- Injection or infusion
- How many people
- 593 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Oct 2017to 31 Oct 2029
- 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Cases will be adults with stable type 2 diabetes and no past medical history of known cardiovascular disease.
Who may be able to join
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged ≥18 and ≤75 years.
- Diagnosed with Stable type 2 diabetes (determined by: i) formal diagnosis in GP case records, ii) a record of diagnostic oral glucose tolerance test OR glycated haemoglobin level ≥6.5%).
Who cannot join
- Angina pectoris or limiting dyspnoea (>NYHA II),
- Major atherosclerotic disease: Symptomatic CAD, history of myocardial infarction, previous revascularisation, stroke/transient ischaemic attack or symptomatic peripheral vascular disease.
- Atrial fibrillation or flutter.
- Moderate or severe valvular heart disease.
- History of heart failure or cardiomyopathy.
- Type 1 diabetes mellitus (T1DM).
Show all 10Show fewer
- Low fasting C-peptide levels suggestive of adult-onset T1DM.
- Stage III-V renal disease (estimated glomerular filtration rate ≤30ml/min/1.73m2).
- Absolute contraindications to CMR.
- Importantly, patients with subclinical CAD, and other common comorbidities such as obesity and hypertension, will not be excluded from this study. This will enable us to evaluate the contribution of CAD to myocardial dysfunction in diabetes and ensures our study group is representative of the general population with diabetes. Similarly, as mild dyspnoea is extremely common and non-specific participants with mild dyspnoea will be included.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Leicester
Leicester
Gaurav S Gulsin, MRCP(UK)
About this study
Background: Heart failure is a major cause of morbidity and mortality in diabetes mellitus, but its pathophysiology is poorly understood.
Aim: To determine the prevalence and determinants of subclinical cardiovascular dysfunction in adults with type 2 diabetes (T2D).
Read more
Plan: 518 asymptomatic adults (aged 18-75 years) with T2D will undergo comprehensive evaluation of cardiac structure and function using cardiac MRI (CMR) and spectroscopy, echocardiography, CT coronary calcium scoring, exercise tolerance testing and blood sampling. 75 controls will undergo the same evaluation.
Primary hypothesis: myocardial steatosis is an independent predictor of left ventricular global longitudinal strain. Secondary hypotheses: will assess whether CMR is more sensitive to detect early cardiac dysfunction than echocardiography and BNP, and whether cardiac dysfunction is related to peak oxygen consumption.
Expected value of results: This study will reveal the prevalence and determinants of cardiac dysfunction in T2D, and could provide targets for novel therapies.
- Being tested
- Cardiovascular magnetic resonance (CMR) imaging and magnetic resonance spectroscopy, Transthoracic echocardiography, Computed tomography coronary artery calcium scoring, Cardiopulmonary exercise testing, Manganese-enhanced magnetic resonance imaging (MEMRI)
- Keywords
- Type 2 diabetes, Diabetic cardiomyopathy, Cardiovascular magnetic resonance
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetic Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiovascular magnetic resonance (CMR) imaging and magnetic resonance spectroscopyDiagnostic test
CMR scanning performed on a 3T MRI scanner. Standardised protocol incorporating cine functional assessment to determine LV mass, systolic function and left atrial volumes; global systolic strain and diastolic strain rates will be assessed by tagging and with tissue tracking analysis from cine images, adenosine rest and stress myocardial perfusion to assess reserve index and qualitative perfusion defects as previously described, aortic distensibility and pulse wave velocity to measure aortic stiffness, delayed contrast enhancement for assessment of LV fibrosis and evidence of previous myocardial infarction. Myocardial and liver triglyceride content will be assessed using the modified Hepafat® sequence or 1H MR spectroscopy at the inter ventricular septum. DIXON technique for the quantification of visceral adiposity and subcutaneous adipose tissue.
Transthoracic echocardiographyDiagnostic test
Comprehensive transthoracic echocardiography, including: tissue Doppler indices of diastolic filling and speckle tracking for systolic and diastolic strain/strain rate, exclusion of valvular abnormalities, assessment of LV size and function.
Computed tomography coronary artery calcium scoringDiagnostic test
Computed Tomography coronary calcium scoring to assess the presence of subclinical atherosclerosis and allow an estimate of atheroma burden in addition to epicardial adipose tissue characterisation and systolic strain.
Cardiopulmonary exercise testingDiagnostic test
Physician supervised incremental symptom limited cardiopulmonary exercise tolerance test with ECG and haemodynamic monitoring.
Manganese-enhanced magnetic resonance imaging (MEMRI)Diagnostic test
A subset of the participants will have cardiac MRI scanning with manganese-based contrast agent, lasting approximately 45-50 minutes. After localisers, baseline functions and native T1 maps have been acquired, Mangafodipir (0.1mL/kg) will be administered intravenously at 1ml/min, with additional T1 maps acquired every 2.5 min after administration of the contrast agent for up to 30 minutes.
Ambulatory blood pressure monitoringDiagnostic test
A 24-hour blood pressure monitor will be worn at the end of the visit to the following day.
Accelerometer watchDiagnostic test
Watch worn to collect free living physical activity data for 7 days.
Blood testsDiagnostic test
Collection of blood samples from each participant to characterise the participant's health status and to develop a proteomic signature of early heart failure.
| Study group | Role | What they receive |
|---|---|---|
| Type 2 diabetics | Participants will be aged (≥18 and ≤75 years) with T2D and no prior history of cardiovascular disease. Receives: Diagnostic Test: Cardiovascular magnetic resonance (CMR) imaging and magnetic resonance spectroscopy; Diagnostic Test: Transthoracic echocardiography; Diagnostic Test: Computed tomography coronary artery calcium scoring; Diagnostic Test: Cardiopulmonary exercise testing; Diagnostic Test: Manganese-enhanced magnetic resonance imaging (MEMRI); Diagnostic Test: Ambulatory blood pressure monitoring; Diagnostic Test: Accelerometer watch; Diagnostic Test: Blood tests | |
| Healthy controls | Cases will be compared with age-, gender- and ethnicity-matched healthy controls. Receives: Diagnostic Test: Cardiovascular magnetic resonance (CMR) imaging and magnetic resonance spectroscopy; Diagnostic Test: Transthoracic echocardiography; Diagnostic Test: Computed tomography coronary artery calcium scoring; Diagnostic Test: Cardiopulmonary exercise testing; Diagnostic Test: Manganese-enhanced magnetic resonance imaging (MEMRI); Diagnostic Test: Ambulatory blood pressure monitoring; Diagnostic Test: Accelerometer watch; Diagnostic Test: Blood tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of early heart failure in type 2 diabetes
Proportion of participants with type 2 diabetes who have features of early heart failure
Measured: 5 years
Secondary outcomes (14)
Multivariate and independent predictors of LV systolic and diastolic function in type 2 diabetes
Multivariate and independent predictors of LV systolic and diastolic function in type 2 diabetes
Measured: 3 years
Sensitivity of CMR versus echocardiography and BNP for detecting subclinical cardiovascular dysfunction in type 2 diabetes
Sensitivity of CMR versus echocardiography and BNP for detecting subclinical cardiovascular dysfunction in type 2 diabetes
Measured: 3 years
Independent association of CMR measures with aerobic exercise capacity in type 2 diabetes
Independent association of CMR measures (LV systolic and diastolic strain and strain rates) with aerobic exercise capacity (peak VO2) in type 2 diabetes
Measured: 3 years
Differences in LV remodelling (indexed LV mass) between cases and controls
Differences in LV remodelling (indexed LV mass) between cases and controls
Measured: 3 years
Independent clinical and imaging predictors of major adverse cardiovascular and, in particular, heart failure events in the patients with type 2 diabetes
Independent clinical and imaging predictors of major adverse cardiovascular and, in particular, heart failure events in the patients with type 2 diabetes
Measured: 5 years
Differences in cardiac MRI and echo-derived systolic and diastolic strain and strain rates between cases and controls.
Differences in cardiac MRI and echo-derived systolic and diastolic strain and strain rates between cases and controls.
Measured: 3 years
Differences in coronary atheroma burden (CT coronary artery calcium score) between cases and controls
Differences in coronary atheroma burden (CT coronary artery calcium score) between cases and controls
Measured: 3 years
Differences in aerobic exercise capacity (peak V02) between cases and controls
Differences in aerobic exercise capacity (peak V02) between cases and controls
Measured: 3 years
Differences in myocardial perfusion reserve between cases and controls
Differences in myocardial perfusion reserve between cases and controls
Measured: 3 years
Differences in heart rate and blood pressure variability between cases and controls
Differences in heart rate and blood pressure variability between cases and controls
Measured: 3 years
Myocardial steatosis
Myocardial steatosis as an independent predictor of LV global longitudinal strain
Measured: 3 years
Myocardial calcium handling as assessed by manganese-enhanced magnetic resonance imaging (MEMRI)
Manganese influx constants calculated using Patlak modelling
Measured: 5 years
Proteomic signature
Proteomic analysis will be conducted to identify a proteomic signature of early heart failure in type 2 diabetes that will be externally validated
Measured: 5 years
Remission of type 2 diabetes
The phenotype of participants defined as in remission will be compared to active type 2 diabetes and healthy volunteers
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2017
- Study start24 Oct 2017
- Primary completion31 Oct 2029 (estimated)
- Study completion31 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 593 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gerry P McCann, MD, Principal investigator, University of Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03132129
- Sponsor's protocol ID
- 0580
- Acronym
- PREDICT
- Status last verified
- Jan 2024
- First submitted
- 19 Apr 2017
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ayton SL, Aslam S, Dattani A, Yeo JL, Gulsin GS, Slomka PJ, Dey D, McCann GP, Singh A. Association of epicardial adipose tissue with markers of cardiac remodelling and clinical outcomes in asymptomatic aortic stenosis. Open Heart. 2026 Feb 9;13(1):e003804. doi: 10.1136/openhrt-2025-003804.
PubMed 41663151Yeo JL, Gulsin GS, Brady EM, Dattani A, Bilak JM, Marsh AM, Sian M, Athithan L, Parke KS, Wormleighton J, Graham-Brown MPM, Singh A, Arnold JR, Lawson C, Davies MJ, Xue H, Kellman P, McCann GP. Association of ambulatory blood pressure with coronary microvascular and cardiac dysfunction in asymptomatic type 2 diabetes. Cardiovasc Diabetol. 2022 May 28;21(1):85. doi: 10.1186/s12933-022-01528-2.
PubMed 35643571
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Determinants of Subclinical Cardiovascular Dysfunction in Adults With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03132129
- Acronym / sponsor ID
- PREDICT / 0580
- Keywords
- Type 2 diabetes, Diabetic cardiomyopathy, Cardiovascular magnetic resonance
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 593 participants (estimated)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Study start
- 24 Oct 2017 (actual)
- Primary completion
- 31 Oct 2029 (estimated)
- Study completion
- 31 Oct 2029 (estimated)
- First posted
- 27 Apr 2017 (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.
Background: Heart failure is a major cause of morbidity and mortality in diabetes mellitus, but its pathophysiology is poorly understood.
Aim: To determine the prevalence and determinants of subclinical cardiovascular dysfunction in adults with type 2 diabetes (T2D).
Plan: 518 asymptomatic adults (aged 18-75 years) with T2D will undergo comprehensive evaluation of cardiac structure and function using cardiac MRI (CMR) and spectroscopy, echocardiography, CT coronary calcium scoring, exercise tolerance testing and blood sampling. 75 controls will undergo the same evaluation.
Primary hypothesis: myocardial steatosis is an independent predictor of left ventricular global longitudinal strain. Secondary hypotheses: will assess whether CMR is more sensitive to detect early cardiac dysfunction than echocardiography and BNP, and whether cardiac dysfunction is related to peak oxygen consumption.
Expected value of results: This study will reveal the prevalence and determinants of cardiac dysfunction in T2D, and could provide targets for novel therapies.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Type 2 diabetics | – | Diagnostic Test: Cardiovascular magnetic resonance (CMR) imaging and magnetic resonance spectroscopy, Diagnostic Test: Transthoracic echocardiography, Diagnostic Test: Computed tomography coronary artery calcium scoring, Diagnostic Test: Cardiopulmonary exercise testing, Diagnostic Test: Manganese-enhanced magnetic resonance imaging (MEMRI), Diagnostic Test: Ambulatory blood pressure monitoring, Diagnostic Test: Accelerometer watch, Diagnostic Test: Blood testsParticipants will be aged (≥18 and ≤75 years) with T2D and no prior history of cardiovascular disease. |
| Healthy controls | – | Diagnostic Test: Cardiovascular magnetic resonance (CMR) imaging and magnetic resonance spectroscopy, Diagnostic Test: Transthoracic echocardiography, Diagnostic Test: Computed tomography coronary artery calcium scoring, Diagnostic Test: Cardiopulmonary exercise testing, Diagnostic Test: Manganese-enhanced magnetic resonance imaging (MEMRI), Diagnostic Test: Ambulatory blood pressure monitoring, Diagnostic Test: Accelerometer watch, Diagnostic Test: Blood testsCases will be compared with age-, gender- and ethnicity-matched healthy controls. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Cases will be adults with stable type 2 diabetes and no past medical history of known cardiovascular disease.
Key inclusion criteria (3 listed)
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged ≥18 and ≤75 years.
- Diagnosed with Stable type 2 diabetes (determined by: i) formal diagnosis in GP case records, ii) a record of diagnostic oral glucose tolerance test OR glycated haemoglobin level ≥6.5%).
Key exclusion criteria (10 listed)
- Angina pectoris or limiting dyspnoea (>NYHA II),
- Major atherosclerotic disease: Symptomatic CAD, history of myocardial infarction, previous revascularisation, stroke/transient ischaemic attack or symptomatic peripheral vascular disease.
- Atrial fibrillation or flutter.
- Moderate or severe valvular heart disease.
- History of heart failure or cardiomyopathy.
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 |
|---|---|---|
| Cardiovascular magnetic resonance (CMR) imaging and magnetic resonance spectroscopyCMR scanning performed on a 3T MRI scanner. Standardised protocol incorporating cine functional assessment to determine LV mass, systolic function and left atrial volumes; global systolic strain and diastolic strain rates will be assessed by tagging and with tissue tracking analysis from cine images, adenosine rest and stress myocardial perfusion to assess reserve index and qualitative perfusion defects as previously described, aortic distensibility and pulse wave velocity to measure aortic stiffness, delayed contrast enhancement for assessment of LV fibrosis and evidence of previous myocardial infarction. Myocardial and liver triglyceride content will be assessed using the modified Hepafat® sequence or 1H MR spectroscopy at the inter ventricular septum. DIXON technique for the quantification of visceral adiposity and subcutaneous adipose tissue. | Diagnostic test | Healthy controls, Type 2 diabetics |
| Transthoracic echocardiographyComprehensive transthoracic echocardiography, including: tissue Doppler indices of diastolic filling and speckle tracking for systolic and diastolic strain/strain rate, exclusion of valvular abnormalities, assessment of LV size and function. | Diagnostic test | Healthy controls, Type 2 diabetics |
| Computed tomography coronary artery calcium scoringComputed Tomography coronary calcium scoring to assess the presence of subclinical atherosclerosis and allow an estimate of atheroma burden in addition to epicardial adipose tissue characterisation and systolic strain. | Diagnostic test | Healthy controls, Type 2 diabetics |
| Cardiopulmonary exercise testingPhysician supervised incremental symptom limited cardiopulmonary exercise tolerance test with ECG and haemodynamic monitoring. | Diagnostic test | Healthy controls, Type 2 diabetics |
| Manganese-enhanced magnetic resonance imaging (MEMRI)A subset of the participants will have cardiac MRI scanning with manganese-based contrast agent, lasting approximately 45-50 minutes. After localisers, baseline functions and native T1 maps have been acquired, Mangafodipir (0.1mL/kg) will be administered intravenously at 1ml/min, with additional T1 maps acquired every 2.5 min after administration of the contrast agent for up to 30 minutes. | Diagnostic test | Healthy controls, Type 2 diabetics |
| Ambulatory blood pressure monitoringA 24-hour blood pressure monitor will be worn at the end of the visit to the following day. | Diagnostic test | Healthy controls, Type 2 diabetics |
| Accelerometer watchWatch worn to collect free living physical activity data for 7 days. | Diagnostic test | Healthy controls, Type 2 diabetics |
| Blood testsCollection of blood samples from each participant to characterise the participant's health status and to develop a proteomic signature of early heart failure. | Diagnostic test | Healthy controls, Type 2 diabetics |
Primary outcome
Prevalence of early heart failure in type 2 diabetes
Time frame: 5 years
Proportion of participants with type 2 diabetes who have features of early heart failure
14 secondary outcomes
Multivariate and independent predictors of LV systolic and diastolic function in type 2 diabetes
Time frame: 3 years
Sensitivity of CMR versus echocardiography and BNP for detecting subclinical cardiovascular dysfunction in type 2 diabetes
Time frame: 3 years
Independent association of CMR measures with aerobic exercise capacity in type 2 diabetes
Time frame: 3 years
Differences in LV remodelling (indexed LV mass) between cases and controls
Time frame: 3 years
Independent clinical and imaging predictors of major adverse cardiovascular and, in particular, heart failure events in the patients with type 2 diabetes
Time frame: 5 years
Differences in cardiac MRI and echo-derived systolic and diastolic strain and strain rates between cases and controls.
Time frame: 3 years
Differences in coronary atheroma burden (CT coronary artery calcium score) between cases and controls
Time frame: 3 years
Differences in aerobic exercise capacity (peak V02) between cases and controls
Time frame: 3 years
Differences in myocardial perfusion reserve between cases and controls
Time frame: 3 years
Differences in heart rate and blood pressure variability between cases and controls
Time frame: 3 years
Myocardial steatosis
Time frame: 3 years
Myocardial calcium handling as assessed by manganese-enhanced magnetic resonance imaging (MEMRI)
Time frame: 5 years
Proteomic signature
Time frame: 5 years
Remission of type 2 diabetes
Time frame: 5 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 5 Jan 2024.
- Derived from this study: PubMed 41663151Ayton SL, Aslam S, Dattani A, Yeo JL, Gulsin GS, Slomka PJ, Dey D, McCann GP, Singh A. Association of epicardial adipose tissue with markers of cardiac remodelling and clinical outcomes in asymptomatic aortic stenosis. Open Heart. 2026 Feb 9;13(1):e003804. doi: 10.1136/openhrt-2025-003804.
- Derived from this study: PubMed 35643571Yeo JL, Gulsin GS, Brady EM, Dattani A, Bilak JM, Marsh AM, Sian M, Athithan L, Parke KS, Wormleighton J, Graham-Brown MPM, Singh A, Arnold JR, Lawson C, Davies MJ, Xue H, Kellman P, McCann GP. Association of ambulatory blood pressure with coronary microvascular and cardiac dysfunction in asymptomatic type 2 diabetes. Cardiovasc Diabetol. 2022 May 28;21(1):85. doi: 10.1186/s12933-022-01528-2.
- 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.
Gerry P McCann, MD principal investigator
University of Leicester
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 Diabetes Mellitus, Type 2 and Diabetic Cardiomyopathies, run by University of Leicester at 1 site 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 10 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 5 Jan 2024. 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 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?
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 Gerry P McCann, MD (01162583402, gpm12@le.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of early heart failure in type 2 diabetes (time frame: 5 years). 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 NCT03132129, which also lists 2 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 5 Jan 2024; AzTrials last refreshed its copy on 7 Nov 2026.