Cardiomyopathy, DilatedMPS-CMR-DCMNCT07527715
Cardiac Magnetic Resonance-Clinical Prediction Model-Dilated Cardiomyopathy
An observational study of Cardiomyopathy, Dilated and Prognosis, run by Shandong Provincial Hospital at 1 site in China.
Trial summary
Dilated cardiomyopathy (DCM) is a common and serious heart disease characterized by left ventricular enlargement and impaired pumping function, with adverse prognosis (including heart failure, arrhythmia, heart-related hospitalization, and death) being a major concern for patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiomyopathy, Dilated, Prognosis, Magnetic Resonance Imaging, Cardiac
- What is being tested?
- left ventricular ejection fraction
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2021to 1 Dec 2038
- How long will I take part?
- 6 Months
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: During the study period, patients with dilated cardiomyopathy (DCM) who were seen in the cardiology departments of Shandong Provincial Hospital, Jinan Central Hospital, and Beijing Anzhen Hospital, or referred for cardiac magnetic resonance (CMR) assessment, were prospectively enrolled in the registry at the time of scanning.
Who may be able to join
- 1.An elevated left ventricular end-diastolic volume indexed to body surface area and reduced LVEF, compared with published age- and gender-specific reference values Exclusion Criteria
- significant coronary artery disease (CAD), defined as a stenosis of ˃50% in a major coronary artery
- infiltrative disease
- valvular cardiomyopathy
- arrhythmogenic cardiomyopathy
- congenital heart disease
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Jinan central hospital
Jinan, Shandong
Jian Wang, 8613361057681, wangjianxjxj@163.com
About this study
Official title: Study on Risk Early Warning of Clinical Prediction Model Based on Multi-Parameter Stress Perfusion Cardiac Magnetic Resonance in Adverse Prognosis of Dilated Cardiomyopathy
Dilated cardiomyopathy (DCM) is a common and serious heart disease characterized by left ventricular enlargement and impaired pumping function, with adverse prognosis (including heart failure, arrhythmia, heart-related hospitalization, and death) being a major concern for patients. Currently, a critical gap exists in accurately predicting which DCM patients are at high risk of these severe outcomes, limiting targeted clinical care.
This observational, non-invasive study aims to develop and validate a clinical prediction model for early risk warning of adverse prognosis in DCM patients. The model integrates multi-parameter stress perfusion cardiac magnetic resonance (MP stress perfusion CMR)-a safe, high-resolution imaging technique that assesses cardiac structure, function, blood perfusion, and tissue damage under mild stress-and standard clinical data (e.g., age, gender, blood pressure, and routine heart test results).
Read more
The model will be trained and tested using follow-up data from hundreds of DCM patients, with the analysis identifying patterns in CMR and clinical data associated with adverse outcomes. Once validated for accuracy, the model will provide doctors with personalized risk scores to prioritize care for high-risk patients (e.g., early intervention, close monitoring) and avoid over-treatment for lower-risk individuals.
Beyond clinical application, the study will enhance understanding of DCM progression, laying the groundwork for improved diagnostic tools, more effective treatments, and better strategies to prevent DCM-related complications, ultimately improving patient quality of life and reducing mortality.
Read the detailed description
The study focuses on a common but serious heart condition called dilated cardiomyopathy (DCM), which affects millions of people worldwide. Dilated cardiomyopathy is a disease where the heart's main pumping chamber (the left ventricle) becomes enlarged and weakened, making pumping function harder for the heart to pump blood efficiently to the rest of the body. For patients with DCM, the biggest concern is the risk of "adverse prognosis"-a category includes serious outcomes like heart failure, abnormal heart rhythms, hospitalizations related to heart problems, or even death. Currently, doctors face challenges in accurately predicting which DCM patients are more likely to experience these severe outcomes, a limitation restricting the ability to provide timely, targeted care to those at highest risk.
To address the gap, the investigators aim to develop and test a "clinical prediction model"-a tool that combines medical data to predict the likelihood of adverse outcomes in DCM patients. The key innovation of the model is the use of a powerful medical imaging technique called multi-parameter stress perfusion cardiac magnetic resonance (MP stress perfusion CMR), combined with standard clinical information about patients.
First, the terms are explained in simple language. Cardiac magnetic resonance (CMR) is a safe, non-invasive imaging test that creates detailed pictures of the heart's structure and function. "Stress perfusion" means that during the CMR scan, the participant's heart is placed under a mild form of stress (usually by administration of a medication that increases heart rate, similar to light exercise) to observe blood flow through the heart muscle during increased workload. "Multi-parameter" refers to the collection of multiple types of information from the CMR scan, such as myocardial contractility, myocardial perfusion, and any damage or scarring in cardiac tissue.
The goal of the study is to use detailed CMR data, along with other basic clinical information (e.g., patient age, gender, blood pressure, and results from standard heart tests), to construct a prediction model. The model will be trained using data from hundreds of DCM patients with existing follow-up records. The investigators will analyze the records to determine which patients experienced adverse outcomes and to identify patterns in CMR and clinical data associated with those outcomes.
Once the model is constructed and tested for accuracy, the tool can be utilized by doctors in clinical practice to assist in the assessment of DCM patients. For example, when a patient is diagnosed with DCM, doctors can perform the CMR scan, input the data into the model, and obtain a personalized risk score indicating the probability of future severe cardiac events in that patient. The resulting information will support clinical decision-making: the scores will allow doctors to prioritize care for high-risk patients-such as early treatment initiation, more frequent monitoring, or medication adjustment-to prevent adverse outcomes. For lower-risk patients, the model can help avoid unnecessary, costly tests or over-treatment.
Beyond individual patient benefits, the study also has broader value for public health and medical research. By better defining the factors (from CMR and clinical data) most closely linked to poor outcomes in DCM, new insights can be gained regarding disease progression. Such insights may lead to improved diagnostic tools, more effective treatments, and enhanced strategies for preventing DCM-related complications in the long term.
Of particular note, the study is observational and non-invasive. All patients receive standard medical care for DCM, and the CMR scan is a routine test already applied in clinical practice. The study will follow patients over time to validate the prediction model, ensuring reliable performance across different subgroups of DCM patients (e.g., varying age, gender, or disease severity).
In summary, the study seeks to bridge a critical gap in the care of DCM patients by creating a reliable, easy-to-use prediction tool based on advanced CMR imaging. By early identification of patients at high risk of adverse outcomes, quality of life can be improved, hospitalizations reduced, and lives potentially saved-while also advancing understanding of the complex heart disease for the benefit of future patients.
- Conditions
- Cardiomyopathy, Dilated, Prognosis, Magnetic Resonance Imaging, Cardiac, Death, Sudden, Cardiac, Heart Failure, Risk Assessment
- Being tested
- left ventricular ejection fraction
- Medical subject headings
- Cardiomyopathy, Dilated, Death, Sudden, Cardiac, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
left ventricular ejection fractionOther
HFrEF:LVEF<40% ; HFmrEF:LVEF40-50%; HFpEF: LVEF>50%
What is being measured
The primary outcome is the main question the study is designed to answer.
SCD-related events
SCD, appropriate implantable cardioverter-defibrillator shock, and resuscitated cardiac arrest
Measured: 1 year, 3 years, and 5 years after CMR examination
Secondary outcomes (1)
heart failure events
heart failure-related death, unplanned heart failure hospitalization, or heart transplantation
Measured: at 1, 3, and 5 years following CMR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start1 Dec 2021
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2038 (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 Cardiomyopathy, DilatedStudies 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
- 2,000 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Shandong Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Wenxian Wang, Shandong Provincial Hospital
- Investigators
- Xi-ming Wang, Study chair, Shandong Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07527715
- Sponsor's protocol ID
- SWYX:NO.2025-740
- Acronym
- MPS-CMR-DCM
- Status last verified
- Apr 2026
- First submitted
- 2 Apr 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be made available to external researchers. The dataset contains sensitive clinical, imaging, and longitudinal prognostic information from patients with dilated cardiomyopathy. Broad sharing of IPD may compromise patient privacy and confidentiality, violate informed consent restrictions, and increase the risk of re-identification. In addition, the multiparametric CMR and artificial intelligence models rely on integrated institutional data that have not been de-identified to a level suitable for unrestricted public or third-party sharing. Therefore, IPD will be retained securely within the study group and will not be shared externally.
Publications
Arbelo E, Protonotarios A, Gimeno JR, Arbustini E, Barriales-Villa R, Basso C, Bezzina CR, Biagini E, Blom NA, de Boer RA, De Winter T, Elliott PM, Flather M, Garcia-Pavia P, Haugaa KH, Ingles J, Jurcut RO, Klaassen S, Limongelli G, Loeys B, Mogensen J, Olivotto I, Pantazis A, Sharma S, Van Tintelen JP, Ware JS, Kaski JP; ESC Scientific Document Group. 2023 ESC Guidelines for the management of cardiomyopathies. Eur Heart J. 2023 Oct 1;44(37):3503-3626. doi: 10.1093/eurheartj/ehad194. No abstract available.
PubMed 37622657
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Risk Early Warning of Clinical Prediction Model Based on Multi-Parameter Stress Perfusion Cardiac Magnetic Resonance in Adverse Prognosis of Dilated Cardiomyopathy
- ClinicalTrials.gov ID
- NCT07527715
- Acronym / sponsor ID
- MPS-CMR-DCM / SWYX:NO.2025-740
- Conditions
- Cardiomyopathy, Dilated, Prognosis, Magnetic Resonance Imaging, Cardiac, Death, Sudden, Cardiac, Heart Failure, Risk Assessment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Shandong Provincial HospitalOther government
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2038 (estimated)
- First posted
- 14 Apr 2026 (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.
Dilated cardiomyopathy (DCM) is a common and serious heart disease characterized by left ventricular enlargement and impaired pumping function, with adverse prognosis (including heart failure, arrhythmia, heart-related hospitalization, and death) being a major concern for patients. Currently, a critical gap exists in accurately predicting which DCM patients are at high risk of these severe outcomes, limiting targeted clinical care.
This observational, non-invasive study aims to develop and validate a clinical prediction model for early risk warning of adverse prognosis in DCM patients. The model integrates multi-parameter stress perfusion cardiac magnetic resonance (MP stress perfusion CMR)-a safe, high-resolution imaging technique that assesses cardiac structure, function, blood perfusion, and tissue damage under mild stress-and standard clinical data (e.g., age, gender, blood pressure, and routine heart test results).
The model will be trained and tested using follow-up data from hundreds of DCM patients, with the analysis identifying patterns in CMR and clinical data associated with adverse outcomes. Once validated for accuracy, the model will provide doctors with personalized risk scores to prioritize care for high-risk patients (e.g., early intervention, close monitoring) and avoid over-treatment for lower-risk individuals.
Beyond clinical application, the study will enhance understanding of DCM progression, laying the groundwork for improved diagnostic tools, more effective treatments, and better strategies to prevent DCM-related complications, ultimately improving patient quality of life and reducing mortality.
Detailed description
The study focuses on a common but serious heart condition called dilated cardiomyopathy (DCM), which affects millions of people worldwide. Dilated cardiomyopathy is a disease where the heart's main pumping chamber (the left ventricle) becomes enlarged and weakened, making pumping function harder for the heart to pump blood efficiently to the rest of the body. For patients with DCM, the biggest concern is the risk of "adverse prognosis"-a category includes serious outcomes like heart failure, abnormal heart rhythms, hospitalizations related to heart problems, or even death. Currently, doctors face challenges in accurately predicting which DCM patients are more likely to experience these severe outcomes, a limitation restricting the ability to provide timely, targeted care to those at highest risk.
To address the gap, the investigators aim to develop and test a "clinical prediction model"-a tool that combines medical data to predict the likelihood of adverse outcomes in DCM patients. The key innovation of the model is the use of a powerful medical imaging technique called multi-parameter stress perfusion cardiac magnetic resonance (MP stress perfusion CMR), combined with standard clinical information about patients.
First, the terms are explained in simple language. Cardiac magnetic resonance (CMR) is a safe, non-invasive imaging test that creates detailed pictures of the heart's structure and function. "Stress perfusion" means that during the CMR scan, the participant's heart is placed under a mild form of stress (usually by administration of a medication that increases heart rate, similar to light exercise) to observe blood flow through the heart muscle during increased workload. "Multi-parameter" refers to the collection of multiple types of information from the CMR scan, such as myocardial contractility, myocardial perfusion, and any damage or scarring in cardiac tissue.
The goal of the study is to use detailed CMR data, along with other basic clinical information (e.g., patient age, gender, blood pressure, and results from standard heart tests), to construct a prediction model. The model will be trained using data from hundreds of DCM patients with existing follow-up records. The investigators will analyze the records to determine which patients experienced adverse outcomes and to identify patterns in CMR and clinical data associated with those outcomes.
Once the model is constructed and tested for accuracy, the tool can be utilized by doctors in clinical practice to assist in the assessment of DCM patients. For example, when a patient is diagnosed with DCM, doctors can perform the CMR scan, input the data into the model, and obtain a personalized risk score indicating the probability of future severe cardiac events in that patient. The resulting information will support clinical decision-making: the scores will allow doctors to prioritize care for high-risk patients-such as early treatment initiation, more frequent monitoring, or medication adjustment-to prevent adverse outcomes. For lower-risk patients, the model can help avoid unnecessary, costly tests or over-treatment.
Beyond individual patient benefits, the study also has broader value for public health and medical research. By better defining the factors (from CMR and clinical data) most closely linked to poor outcomes in DCM, new insights can be gained regarding disease progression. Such insights may lead to improved diagnostic tools, more effective treatments, and enhanced strategies for preventing DCM-related complications in the long term.
Of particular note, the study is observational and non-invasive. All patients receive standard medical care for DCM, and the CMR scan is a routine test already applied in clinical practice. The study will follow patients over time to validate the prediction model, ensuring reliable performance across different subgroups of DCM patients (e.g., varying age, gender, or disease severity).
In summary, the study seeks to bridge a critical gap in the care of DCM patients by creating a reliable, easy-to-use prediction tool based on advanced CMR imaging. By early identification of patients at high risk of adverse outcomes, quality of life can be improved, hospitalizations reduced, and lives potentially saved-while also advancing understanding of the complex heart disease for the benefit of future patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- During the study period, patients with dilated cardiomyopathy (DCM) who were seen in the cardiology departments of Shandong Provincial Hospital, Jinan Central Hospital, and Beijing Anzhen Hospital, or referred for cardiac magnetic resonance (CMR) assessment, were prospectively enrolled in the registry at the time of scanning.
Key inclusion criteria (6 listed)
- 1.An elevated left ventricular end-diastolic volume indexed to body surface area and reduced LVEF, compared with published age- and gender-specific reference values Exclusion Criteria
- significant coronary artery disease (CAD), defined as a stenosis of ˃50% in a major coronary artery
- infiltrative disease
- valvular cardiomyopathy
- arrhythmogenic cardiomyopathy
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| left ventricular ejection fractionHFrEF:LVEF<40% ; HFmrEF:LVEF40-50%; HFpEF: LVEF>50% | Other | – |
Primary outcome
SCD-related events
Time frame: 1 year, 3 years, and 5 years after CMR examination
SCD, appropriate implantable cardioverter-defibrillator shock, and resuscitated cardiac arrest
1 secondary outcome
heart failure events
Time frame: at 1, 3, and 5 years following CMR
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 14 Apr 2026.
- Background: PubMed 37622657Arbelo E, Protonotarios A, Gimeno JR, Arbustini E, Barriales-Villa R, Basso C, Bezzina CR, Biagini E, Blom NA, de Boer RA, De Winter T, Elliott PM, Flather M, Garcia-Pavia P, Haugaa KH, Ingles J, Jurcut RO, Klaassen S, Limongelli G, Loeys B, Mogensen J, Olivotto I, Pantazis A, Sharma S, Van Tintelen JP, Ware JS, Kaski JP; ESC Scientific Document Group. 2023 ESC Guidelines for the management of cardiomyopathies. Eur Heart J. 2023 Oct 1;44(37):3503-3626. doi: 10.1093/eurheartj/ehad194. No abstract available.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be made available to external researchers. The dataset contains sensitive clinical, imaging, and longitudinal prognostic information from patients with dilated cardiomyopathy. Broad sharing of IPD may compromise patient privacy and confidentiality, violate informed consent restrictions, and increase the risk of re-identification. In addition, the multiparametric CMR and artificial intelligence models rely on integrated institutional data that have not been de-identified to a level suitable for unrestricted public or third-party sharing. Therefore, IPD will be retained securely within the study group and will not be shared externally.
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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.
Xi-ming Wang study chair
Shandong Provincial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiomyopathy, Dilated and Prognosis, run by Shandong Provincial Hospital at 1 site in China.
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 6 inclusion and 0 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 14 Apr 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 China. 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 Wenxian Wang, Dr (8617705414294, wwx990511@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SCD-related events (time frame: 1 year, 3 years, and 5 years after CMR examination). 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 NCT07527715, 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 14 Apr 2026.