Multimodal Cardiovascular Magnetic Resonance Imaging for Cardiometabolic Pre-HF and HFpEF: Integrated Phenotyping, Precision Diagnosis, and Risk Stratification
Overview
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
- Enrollment
- 3,000
- Primary Endpoint
- Incidence Rate of all cause or cardiovascular death
Overview
Brief Summary
This is an observational study aiming to characterize the pathophysiological features and clinical significance of cardiometabolic early-stage heart failure using advanced multimodal cardiovascular magnetic resonance (CMR) imaging. The study will focus on patients with cardiometabolic risk factors such as diabetes, hypertension, and obesity who are in the pre-heart failure (pre-HF) stage or have heart failure with preserved ejection fraction (HFpEF). The study seeks to establish a full-chain imaging framework-from precise phenotypic classification and sensitive noninvasive diagnosis to individualized cardiovascular risk stratification. Participants will undergo multimodal CMR scans and comprehensive clinical evaluations and be followed up for primary outcome.
Detailed Description
Advanced noninvasive multimodal cardiovascular magnetic resonance (CMR) imaging techniques-including early functional impairment detection (feature tracking), myocardial tissue characterization (T1 mapping), hemodynamic changes (hemodynamic force [HDF] analysis), and magnetic resonance spectroscopy-have significant potential clinical value, especially for capturing the complex pathophysiology of cardiometabolic early-stage heart failure.
This study applies these advanced CMR imaging techniques to individuals with cardiometabolic risk factors and early-stage heart failure (pre-HF and HFpEF) to perform multidimensional, comprehensive CMR analyses. The goal is to identify characteristic imaging patterns for this cohort, develop targeted diagnostic models, facilitate their application in risk prediction and individualized management, and ultimately establish an imaging evaluation framework that can optimize clinical pathways for cardiometabolic pre-HF and HFpEF.
This study enrolls patients undergoing CMR who have early-stage cardiometabolic heart failure (pre-HF and HFpEF), including with diabetes, hypertension, obesity and so on. Clinical data, laboratory results, and echocardiographic parameters will be collected.
Through cross-sectional analysis, the study will evaluate chamber structure and function, myocardial tissue characteristics, hemodynamics, and myocardial energy metabolism, and summarize characteristic imaging phenotypes of cardiometabolic early-stage heart failure. Imaging parameters will be compared to identify robust noninvasive diagnostic markers and optimize the diagnostic framework for cardiometabolic early-stage heart failure. In addition, participants will be followed longitudinally to collect outcome events. The predictive value of CMR-derived indicators for clinical outcomes will be analyzed, and risk prediction models will be developed to achieve precise risk stratification for patients with early-stage cardiometabolic heart failure.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Left ventricular ejection fraction (LVEF) ≥ 50%；
- •Presence of cardiovascular risk factors, including, but not limited to, the following: diabetes mellitus, hypertension, obesity.
Exclusion Criteria
- •Primary cardiomyopathy (e.g., hypertrophic, dilated, and restrictive cardiomyopathy)
- •Acute coronary syndrome in the previous 30 days
- •More than moderate valvular disease
- •Restrictive pericardial disease
- •Severe arrhythmia
- •Heart tumors
- •Infiltrative cardiomyopathy (e.g., cardiac amyloidosis)
- •Congenital heart disease
- •Poor image quality insufficient for delineating the endocardium and epicardium
Outcomes
Primary Outcomes
Incidence Rate of all cause or cardiovascular death
Time Frame: 2-15 years
Incidence Rate of HF hospitalization
Time Frame: 2-15 years
HF hospitalization was defined as an unplanned hospitalization with documented clinical and radiological evidence for HF and need for diuretic treatment
all cause or cardiovascular death
Time Frame: 5-year
Secondary Outcomes
No secondary outcomes reported
Investigators
Minjie Lu
Director of Magnetic Resonance Imaging
Chinese Academy of Medical Sciences, Fuwai Hospital