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NCT Number: NCT07351838

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

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.

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Key information

Conditions

Non-ischemic Cardiomyopathy

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chinese Academy of Medical Sciences and Peking Union Medical College, Fuwai Hospital

Beijing, 100037, China

Location status: Recruiting

Location contact

Lu Minjie PHD

CONTACT

[email protected]

+86 10 88398175

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

No intervention; Observational study

Other

No intervention; Observational study

Primary outcomes

major hard cardiac event

Time frame: 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.

Study contacts

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

Lu Minjie PHD

CONTACT

[email protected]

+86-10-88396941

Sponsors and collaborators

Lead sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2028
Study completion: 2030
First posted: Jan 20, 2026
Registry last updated: Jan 21, 2026

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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