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Cardiac Magnetic Resonance for Risk Stratification in Dilated Cardiomyopathy

Cardiac Magnetic Resonance for Risk Stratification in Dilated Cardiomyopathy

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04990297
Enrollment
2500
Registered
2021-08-04
Start date
2019-12-24
Completion date
2031-12-31
Last updated
2022-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dilated Cardiomyopathy, Single-center Study

Keywords

dilated cardiomyopathy, cardiovascular magnetic resonance imaging, prognosis

Brief summary

Dilated cardiomyopathy (DCM) is an increasingly recognized cause of morbidity and mortality with heterogenous etiologies (eg, genetic, environment) and clinical manifestations, characterized by left ventricular (LV) systolic dysfunction and LV or biventricular dilation. Previous publications reported the three-year treated mortality rates remain high at 12%-20% and a reported 5-year mortality rate up to 50%, with death resulting from ventricular arrhythmia leading to sudden cardiac death (SCD) or advanced heart failure (HF). With large fields of view and high spatial resolution, Cardiac magnetic resonance (CMR) is the reference standard for assessing cardiac mass, volume, and function. CMR also provides non noninvasive characterization of the myocardium benefiting to differential diagnosis and risk stratification.

Interventions

None listed

Sponsors

Chinese Academy of Medical Sciences, Fuwai Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

1. reduced left ventricular ejection fraction (LVEF\<50%) 2. LV end-diastolic volume \>2SD from normal according to normograms corrected by body surface area (BSA) and age.

Exclusion criteria

1. Any evidence indicating the presence of ischemic heart disease: Coronary angiography, perfusion imaging Medical documentation that indicated the presence of ischemic heart disease An infarct pattern of late gadolinium enhancement on cardiac magnetic resonance studies and/or acute coronary syndrome or coronary revascularization during follow-up 2. Any evidence of hypertrophic cardiomyopathy, or moderate-to-severe valvular disease\[18\], or infiltrative disease (such as amyloidosis, sarcoidosis, Fabry disease) 3. Incessant arrhythmias 4. Inability to lie flat 5. Pregnancy 6. Contraindication to cardiac magnetic resonance including severe claustrophobia, defibrillators, pacemakers, certain types of intracranial aneurysm clips, intraocular metal, and Stage IV/V chronic kidney disease 7. Diabetes mellitus with end organ damage 8. Inability to provide informed consent.

Design outcomes

Primary

MeasureTime frameDescription
All-cause Mortality1-10yearsthe incidence of all-cause death the incidence of all-cause death the incidence of all-cause death the incidence of all-cause mortality

Secondary

MeasureTime frameDescription
A composite of SCD and aborted SCD1-10yearsSCD, defined as unexpected death within ≤1 hour of cardiac symptoms in the absence of any progressive cardiac deterioration, during sleep, or ≤24 hours of last being seen alive. Aborted SCD, defined as an appropriate implantable cardioverter defibrillator shock for ventricular arrhythmia, a nonfatal episode of ventricular fibrillation or spontaneous sustained ventricular tachycardia causing hemodynamic compromise and requiring cardioversion
Deterioration of HF1-10yearsHF-death, heart transplantation, left ventricular assist device
Major adverse cardiac events1-10yearsall-cause mortality, heart transplantation, left ventricular assist device, aborted SCD, sustained ventricular tachycardia and hospitalization for heart failure

Countries

China

Contacts

Primary ContactMinjie Lu, PhD
coolkan@163.com+86-10-88396941

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026