Cardiac Magnetic Resonance for Risk Stratification in Dilated Cardiomyopathy

Recruiting

• Conditions: Dilated Cardiomyopathy; Single-center Study

• Registration Number: NCT04990297
• Lead Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-24
• Study First Submitted: 2021-07-27
• Study First Submitted QC: 2021-07-27
• Study First Posted: 2021-08-04
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-27
• Last Update Posted: 2022-10-31
• Primary Completion: 2030-12-31
• Study Completion: 2031-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
A composite of SCD and aborted SCD	1-10years	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
Deterioration of HF	1-10years	HF-death, heart transplantation, left ventricular assist device
Major adverse cardiac events	1-10years	all-cause mortality, heart transplantation, left ventricular assist device, aborted SCD, sustained ventricular tachycardia and hospitalization for heart failure

Trial Locations

Locations (1)

Fuwai Hospital; 🇨🇳 Beijing, Beijing, China