Cardiac Magnetic Resonance for Risk Stratification in Non-dilated Left Ventricular Cardiomyopathy
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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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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