Cardiac Magnetic Resonance for Risk Stratification in Dilated Cardiomyopathy

NCT04990297 · tracked via the Priya Life Science China tracker

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Phase

Observational

Started

2019-12-24

Last updated

2022-10-31

Condition(s) studied

Dilated CardiomyopathySingle-center Study

Study 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.

Eligibility

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

All-cause Mortality — 1-10years
the incidence of all-cause death the incidence of all-cause death the incidence of all-cause death the incidence of all-cause mortality

Trial sites (1)

Facility	City	Region	Status
Fuwai Hospital	Beijing	Beijing Municipality	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04990297 on ClinicalTrials.gov ↗ ← All trials in China