Clinical trial NCT04990297: Cardiac Magnetic Resonance for Risk Stratification in Dilated Cardiomyopathy
Official title: Cardiac Magnetic Resonance for Risk Stratification in Dilated Cardiomyopathy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dilated Cardiomyopathy
Single-center Study
Keywords: dilated cardiomyopathy
cardiovascular magnetic resonance imaging
prognosis
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2021-08-04
Enrollment: 2500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study is a prospective, single-center, observational registry including consecutive patients with DCM who undergo clinical evaluation, blood draw for genetics and biomarker assessment, echocardiography, and CMR.

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.


Eligibility criteria: 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 outcomes:
measure: All-cause Mortality
timeFrame: 1-10years
Secondary outcomes:
measure: A composite of SCD and aborted SCD
timeFrame: 1-10years
measure: Deterioration of HF
timeFrame: 1-10years
measure: Major adverse cardiac events
timeFrame: 1-10years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital
state: Beijing
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Minjie Lu, PhD
role: STUDY_CHAIR
References:
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