Cardiac Magnetic Resonance for Risk Stratification in Non-dilated Left Ventricular Cardiomyopathy

NCT07351838 · tracked via the Priya Life Science China tracker

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Phase

Observational

Started

2010-01-01

Last updated

2026-01-21

Condition(s) studied

Non-ischemic Cardiomyopathy

Investigational drug(s) / intervention(s)

No intervention; Observational study

No intervention; Observational study: No intervention; Observational study

Study summary

Non-dilated left ventricular cardiomyopathy (NDLVC), a newly defined cardiomyopathy subtype characterized by non-ischemic myocardial abnormalities without left ventricular dilation, poses challenges in prognosis assessment and risk stratification. This is a retrospective observational study aiming to explore the prognostic value of cardiac magnetic resonance (CMR) findings and identify key risk factors for adverse cardiovascular outcomes in patients with NDLVC.

We will retrospectively enroll patients diagnosed with NDLVC who underwent CMR examination at the study institution during the predefined study period. CMR parameters, including left ventricular ejection fraction (LVEF), late gadolinium enhancement (LGE) patterns, myocardial strain, and the extent of myocardial fibrosis or fatty replacement, will be extracted and analyzed. The primary endpoint is a composite of major adverse cardiovascular events (MACE), including all-cause mortality, heart transplantation, or left ventricular assist device (LVAD) implantation.

The study intends to clarify the association between specific CMR features and long-term prognosis in NDLVC patients, thereby establishing a CMR-based risk stratification strategy to guide clinical decision-making and improve patient outcomes. Given the retrospective nature, data will be collected from electronic medical records and CMR databases, with ethical approval obtained prior to study initiation.

Eligibility

Sex

ALL

Min age

16 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * age ≥ 16 years; * indexed left ventricular end-diastolic volume (LVEDVi) \<96 mL/m2 in females and \<105 mL/m2 in males at baseline cardiac magnetic resonance (CMR); * either left ventricular ejection fraction (LVEF) \<50% and/or non-ischemic left ventricular (LV) scar/fatty replacement at baseline cardiac magnetic resonance. Exclusion Criteria: * lacked enhanced CMR images due to contraindications for receiving gadolinium contrast, such as severe renal disease; * ischemic heart disease, defined as stenosis of \>50% in a major epicardial coronary artery underwent coronary computed tomography angiography or coronary angiography, ischemic late gadolinium enhancement (LGE) pattern on CMR indicating prior infarction, or prior coronary revascularization; * abnormal loading conditions, defined as moderate to severe valvular heart diseases, congenital heart diseases, uncontrolled hypertension; * systemic rheumatologic diseases or sarcoidosis; * diagnostic criteria for other cardiomyopathies according to the European Society of Cardiology (ESC) definitions.

Primary outcome measure(s)

major hard cardiac event — From date of randomization until death, heart transplantation, implantation of a ventricular assist device, or the last clinical follow-up available, assessed up to 100 months.
The primary endpoint was a composite of all-cause mortality, heart transplantation, or left ventricular assist device (LVAD) implantation. The secondary endpoint was sudden cardiac death (SCD)-related events, encompassing SCD, resuscitated cardiac arrest, ventricular fibrillation or sustained ventricular tachycardia leading to hemodynamic compromise requiring cardioversion, or appropriate implantable cardioverter-defibrillator (ICD) therapy \[anti-tachycardia pacing (ATP), or shock\] and heart failure (HF)-related endpoints, including HF death, heart transplant, and HF hospitalization.

Trial sites (1)

Facility	City	Region	Status
Chinese Academy of Medical Sciences and Peking Union Medical College, Fuwai Hospital	Beijing	China	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 NCT07351838 on ClinicalTrials.gov ↗ ← All trials in China