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Cardiac Magnetic Resonance for Risk Stratification in Dilated Cardiomyopathy

ConditionsDilated CardiomyopathySingle-center Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorChinese Academy of Medical Sciences, Fuwai Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

reduced left ventricular ejection fraction (LVEF<50%)

LV end-diastolic volume >2SD from normal according to normograms corrected by body surface area (BSA) and age.

Disqualifiers

Any evidence of hypertrophic cardiomyopathy, or moderate-to-severe valvular disease[18], or infiltrative disease (such as amyloidosis, sarcoidosis, Fabry disease)

Incessant arrhythmias

Inability to lie flat

Pregnancy

Trial 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.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

All-cause Mortality

the incidence of all-cause death the incidence of all-cause death the incidence of all-cause death the incidence of all-cause mortality

Time frame
1-10years

Secondary outcomes

1

A composite of SCD and aborted SCD

SCD, 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

Time frame
1-10years
2

Deterioration of HF

HF-death, heart transplantation, left ventricular assist device

Time frame
1-10years
3

Major adverse cardiac events

all-cause mortality, heart transplantation, left ventricular assist device, aborted SCD, sustained ventricular tachycardia and hospitalization for heart failure

Time frame
1-10years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chinese Academy of Medical Sciences, Fuwai Hospital

Lead sponsor

Source ClinicalTrials.gov
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