Cardiac Magnetic Resonance-Clinical Prediction Model-Dilated Cardiomyopathy

NCT07527715 | Recruiting

• 1 other identifier: SWYX:NO.2025-740
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cardiomyopathy, Dilated; Prognosis; Magnetic Resonance Imaging, Cardiac; Death, Sudden, Cardiac; Heart Failure; Risk Assessment; Stress Perfusion

Outcome Measures

Primary Outcomes (1)

• SCD-related events

  SCD, appropriate implantable cardioverter-defibrillator shock, and resuscitated cardiac arrest

  1 year, 3 years, and 5 years after CMR examination

Secondary Outcomes (1)

• heart failure events

  at 1, 3, and 5 years following CMR

Other Outcomes (1)

• all-cause mortality

  follow-up will be conducted at 1, 3, and 5 years

Interventions

left ventricular ejection fraction OTHER

HFrEF：LVEF\<40% ; HFmrEF：LVEF40-50%; HFpEF: LVEF\>50%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Shandong Provincial Hospital: lead

Study Sites (1)

Jinan central hospital

Jinan, Shandong, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 37622657 BACKGROUND

MeSH Terms

Conditions

Cardiomyopathy, Dilated; Death, Sudden, Cardiac; Heart Failure

Condition Hierarchy (Ancestors)

Cardiomegaly; Heart Diseases; Cardiovascular Diseases; Cardiomyopathies; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Arrest; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Xi-ming Wang

  Shandong Provincial Hospital

  STUDY CHAIR

Central Study Contacts

Wenxian Wang, Dr

CONTACT

8617705414294; wwx990511@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: April 14, 2026
• Study Start: December 1, 2021
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2038
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)