Cardiac MRI for risk prediction in non-dilated left ventricular cardiomyopathy

Prognosis and Risk Stratification in Non-dilated Left Ventricular Cardiomyopathy : Cardiac MRI Insights for Better Outcomes

This retrospective study will test whether findings on cardiac MRI can help predict serious heart problems in people with non-dilated left ventricular cardiomyopathy.

Quick facts

• Study type: Observational
• Enrollment: 1000 (estimated)
• Ages: 16 Years and up
• Sex: All
• Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital (other)
• Locations: 1 site (Beijing)
• Trial ID: NCT07351838 on ClinicalTrials.gov

What this trial studies

This is a retrospective observational cohort drawn from patients diagnosed with non-dilated left ventricular cardiomyopathy who underwent cardiac magnetic resonance (CMR) at a single tertiary center. CMR measures including left ventricular ejection fraction, late gadolinium enhancement patterns, myocardial strain, and the extent of fibrosis or fatty replacement will be extracted from imaging records. Patients meeting indexed LVEDV thresholds with LVEF <50% and/or non-ischemic scar/fat on CMR will be included and followed using chart review for clinical outcomes. The primary outcome is a composite of major adverse cardiovascular events, such as all-cause mortality and heart transplantation, with statistical modeling used to identify imaging predictors and other risk factors.

Who should consider this trial

Good fit: Ideal candidates are people aged 16 or older with non-dilated left ventricles by indexed LVEDV who have LVEF <50% and/or non-ischemic myocardial scar or fatty replacement on CMR performed at the center.

Not a fit: Patients with ischemic heart disease, moderate-to-severe valvular or congenital heart disease, systemic rheumatologic disease or sarcoidosis, or those without contrast-enhanced CMR images are unlikely to benefit from this analysis.

Why it matters

Potential benefit: If successful, the results could help clinicians identify higher-risk patients earlier and tailor monitoring or treatment accordingly.

How similar studies have performed: Prior CMR research in non-ischemic cardiomyopathy has shown that LGE and strain relate to outcomes, but the non-dilated LV cardiomyopathy subtype is newly defined and less extensively studied.

Eligibility criteria

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.

Where this trial is running

Beijing

• Chinese Academy of Medical Sciences and Peking Union Medical College, Fuwai Hospital — Beijing, China (RECRUITING)

Study contacts

• Study coordinator: Lu Minjie PHD

Conditions: Non-ischemic Cardiomyopathy