This is a combined retrospective-prospective observational cohort study investigating the role of systemic and local cardiometabolic risk factors in cardiac structural/functional remodeling and clinical outcomes among heart failure (HF) patients. The study integrates retrospective clinical data (from the past 10 years) and prospective longitudinal follow-up (5 years) of HF patients across HF with reduced (HFrEF), mildly-reduced (HFmrEF), preserved (HFpEF) and improved ejection fraction (HFimpEF) phenotypes. Systemic metabolic factors (e.g., blood lipid profiles, glycemic levels, insulin resistance) and local factors (e.g., epicardial adipose tissue \[EAT\], perivascular adipose tissue \[PVAT\]) will be analyzed for their associations with changes in cardiac geometrics and function, dynamic transitions between HF phenotypes, as well as the occurrence of major adverse cardiovascular events (MACEs). The study seeks to advance risk stratification by integrated evaluation of cardiometabolic profiles so as to refine personalized cures in HF management.
This is a combined retrospective-prospective observational cohort study aiming to elucidate the interplay between systemic/localized cardiometabolic risk factors and their impact on myocardial remodeling, cardiac function, and clinical trajectories in heart failure (HF) patients. By harmonizing retrospective clinical data spanning the past decade with a 5-year prospective longitudinal follow-up, the study encompasses all HF phenotypes, including reduced (HFrEF), mildly reduced (HFmrEF), preserved (HFpEF), and improved ejection fraction (HFimpEF), to capture the full spectrum of disease heterogeneity. Systemic metabolic dysregulation, such as dyslipidemia, impaired glucose metabolism, obesity and other metabolites assessed by mass spectrometry (MS), will be evaluated alongside localized factors, such as epicardial adipose tissue (EAT), perivascular adipose tissue (PVAT) quantified by advanced imaging modalities (cardiac MRI or CT). These factors will be correlated with changes in cardiac geometry (e.g., left ventricular mass, chamber dimensions, wall thickness) and function (e.g., ejection fraction, strain imaging, diastolic parameters), dynamic transitions between HF phenotypes (e.g., HFrEF to HFimpEF), as well as the occurrence of major adverse cardiovascular events (MACEs), defined as a composite of HF re-hospitalization and cardiovascular death. The prospective cohort will undergo standardized baseline assessments (blood biomarkers, echocardiography, cardiac CT or MRI) followed by routine clinical, biochemical and imaging evaluations at least 3-month intervals. Retrospective data will be extracted from electronic health records, including historical imaging studies, laboratory results, and event documentation, ensuring a robust sample size (target n≈3500 retrospective; n≈1200 prospective) for stratified analyses by HF phenotype, sex, and metabolic risk tertiles. Advanced statistical approaches, including multivariable regression analysis, multivariable Cox proportional hazards models and machine learning algorithms, will identify independent predictors for cardiac remodeling, functional alterations, HF phenotype transitions and MACEs. Ethical approval and informed consent are obtained for prospective participants, with retrospective data anonymized to ensure privacy. This study is expected to refine risk stratification tools by integrating metabolic imaging biomarkers and biochemical profiles, ultimately guiding personalized therapeutic cures for HF patients.
Study Type
OBSERVATIONAL
Enrollment
5,000
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, China
RECRUITINGChanges in cardiac function
Changes in ejection fraction (EF) measured by echocardiography or cardiac MRI at baseline and during follow-up.
Time frame: 12 months
Major cardiovascular events (MACEs)
A composite endpoint of HF re-hospitalizaion and cardiovascular death during follow-up
Time frame: 5 years
HF re-hospitalization
The occurrence of protocol-adjudicated, unplanned hospitalization (≥24 hours requiring intravenous therapy for worsening HF, validated by symptomatic/hemodynamic criteria and biomarker/imaging evidence) during follow-up.
Time frame: 5 years
Cardiovascular death
The occurrence of cardiovascular death during follow-up.
Time frame: 5 years
All-cause mortality
The occurrence of death during follow-up
Time frame: 5 years
Dynamic transition among HF phenotypes
The occurrence of transition among HF phenotypes (HFrEF, HFimpEF, HFmrEF, HFpEF) measured by echocardiography or cardiac MRI at baseline and during follow-up
Time frame: 12 months
Changes in cardiac diastolic function
Changes in diastolic function (E/e' and E/A), measured by echocardiography at baseline an follow-up
Time frame: 12 months
Changes in cardiac regional myocardial contractile function
Changes in wall motion score index (WMSI) measured by echocardiography at baseline and follow-up
Time frame: 12 months
Changes in left ventricular strain
Changes in left ventricular strain measured by echocardiography or cardiac MR at baseline and during follow-up.
Time frame: 12 months
Changes in left atrial strain
Changes in left atrial strain measured by echocardiography or cardiac MR at baseline and during follow-up.
Time frame: 12 months
Changes in chamber dimensions
The changes in chamber dimensions analyzed by echocardiography or cardiac MRI at baseline and during follow-up
Time frame: 12 months
Changes in left ventricular mass
The changes in cardiac left ventricular mass analyzed by echocardiography or cardiac MRI at baseline and during follow-up.
Time frame: 12 months
Cardiac wall thickness
The changes in wall thickness analyzed by echocardiography or cardiac MRI at baseline and during follow-up.
Time frame: 12 months
Changes in epicardial adipose tissue (EAT) volume
Changes in the volume of EAT measured by cardiac CT or MRI and quantification analysis at baseline and during follow-up.
Time frame: 12 months
Changes in epicardial adipose tissue (EAT) density
Changes in the density of EAT measured by cardiac CT or MRI and quantification analysis at baseline and during follow-up.
Time frame: 12 months
Changes in epicardial adipose tissue (EAT) distribution
Changes in the distribution of EAT measured by cardiac CT or MRI and quantification analysis at baseline and during follow-up.
Time frame: 12 months
Changes in perivascular adipose tissue (PVAT) volume
Changes in the volume of PVAT measured by coronary CT angiography and quantification analysis at baseline and during follow-up.
Time frame: 12 months
Changes in perivascular adipose tissue (PVAT) density
Changes in the density of PVAT measured by coronary CT angiography and quantification analysis at baseline and during follow-up.
Time frame: 12 months
Changes in perivascular adipose tissue (PVAT) distribution
Changes in the distribution of PVAT measured by coronary CT angiography and quantification analysis at baseline and during follow-up.
Time frame: 12 months
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