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

January 19, 2026 updated by: Minjie Lu, Chinese Academy of Medical Sciences, Fuwai Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China, 100037
        • Recruiting
        • Chinese Academy of Medical Sciences and Peking Union Medical College, Fuwai Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Non-dilated left ventricular cardiomyopathy (NDLVC), formally recognized in the 2023 ESC guidelines as a distinct entity,1 encapsulates patients with non-ischemic fibrosis or fatty replacement or isolated systolic dysfunction without ventricular dilatation.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
NDLVC
Other: No intervention; Observational study
No intervention; Observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2010

Primary Completion (Estimated)

December 30, 2028

Study Completion (Estimated)

December 30, 2030

Study Registration Dates

First Submitted

December 29, 2025

First Submitted That Met QC Criteria

January 11, 2026

First Posted (Actual)

January 20, 2026

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 19, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMRNDLVC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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