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NCT Number: NCT04990297

Cardiac Magnetic Resonance for Risk Stratification in Dilated Cardiomyopathy

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.

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Key information

Conditions

Dilated Cardiomyopathy Cardiomegaly Cardiomyopathies Cardiomyopathy, Dilated Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Heart Diseases Laminopathies Single-center Study

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

  • 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
  • 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
  • Diabetes mellitus with end organ damage
  • Inability to provide informed consent.

Treatment and study plan

Primary outcomes

  1. All-cause Mortality

    Time frame: 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 outcomes

  1. A composite of SCD and aborted SCD

    Time frame: 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

  2. Deterioration of HF

    Time frame: 1-10years

    HF-death, heart transplantation, left ventricular assist device

  3. Major adverse cardiac events

    Time frame: 1-10years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Minjie Lu, PhD

CONTACT

[email protected]

+86-10-88396941

Sponsors and collaborators

Lead sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Other

Registry information

Important dates

Study start
2019
Primary completion
2030
Study completion
2031
First posted
Aug 4, 2021
Registry last updated
Oct 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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