This is a prospective single-center cohort study conducted at The First Affiliated Hospital of Xinjiang Medical University, aiming to enroll 400 patients with chronic heart failure (including HFrEF, HFmrEF, HFpEF) and 200 healthy controls.We will collect clinical data (e.g., NYHA class, NT-proBNP), multi-omics samples (genome, proteome, metabolome, gut microbiome), and imaging indicators (e.g., EAT density, myocardial strain) from participants at baseline. For patients treated with SGLT2 inhibitors, we will also track dynamic changes in multi-omics during follow-up.The main purpose is to build a composite risk prediction model (integrating multi-omics and clinical indicators) to predict the 1-year composite endpoint (heart failure rehospitalization or all-cause death). Secondary goals include identifying specific molecular profiles related to heart failure phenotypes, exploring the "gut-heart axis" mechanism, and finding early biomarkers for SGLT2 inhibitor response.All participants will be followed up for at least 12 months, and the study will strictly comply with ethical norms and protect the privacy of participants.
None
None
This study enrolls 2 groups of participants at The First Affiliated Hospital of Xinjiang Medical University:(1)400 patients with chronic heart failure (stratified into HFrEF, HFmrEF, and HFpEF per 2022 ESC criteria), aged 18 to 80 years;(2)200 age- and gender-matched healthy controls (1:2 matching ratio with CHF patients) without a history of cardiovascular disease, aged 18 to 80 years.
Cohort
Prospective
Not listed
1-Year Composite Endpoint by HF Subtype (Heart Failure Rehospitalization or All-Cause Death)
Occurrence of heart failure-related rehospitalization or all-cause death within 12 months after enrollment, stratified by heart failure subtypes (HFrEF, HFmrEF, HFpEF).Subtype stratification is based on the 2022 ESC HF classification criteria; endpoints are confirmed by the study's clinical endpoint adjudication committee.
1-Year Heart Failure-Related Rehospitalization (Independent Endpoint)
Occurrence of rehospitalization due to worsening heart failure (confirmed by clinical symptoms, NT-proBNP elevation, and echocardiographic changes) within 12 months after enrollment.Rehospitalization is verified by hospital admission records and discharge diagnoses; NT-proBNP and echocardiography data are collected from the hospital's electronic medical record system.
Identification of Heart Failure Phenotype-Specific Molecular Signatures (Multi-Omics Biomarker Panel)
Screening for subtype-specific molecular markers (differentially expressed genes, signature proteins, characteristic metabolites, and gut microbial taxa) that can distinguish heart failure subtypes (HFrEF, HFmrEF, HFpEF) via baseline multi-omics differential analysis.Multi-omics data are analyzed by bioinformatics tools: PCA for dimensionality reduction, DESeq2/limma for differential expression analysis, WGCNA for co-expression network construction; subtype-specific signatures are validated using ROC curves (AUC ≥ 0.75 is considered a potential biomarker).
Correlation Between Multi-Omics Profiles and Clinical Phenotypes of Heart Failure
Correlation between baseline multi-omics profiles (genome, proteome, metabolome, gut microbiome) of heart failure patients and clinical phenotypes (including NYHA functional class, left ventricular ejection fraction \[LVEF\], NT-proBNP level, and 6-minute walk distance).Correlation is quantified using statistical methods: Pearson correlation analysis (for continuous variables) or Spearman correlation analysis (for categorical variables); partial least squares regression (PLSR) is used to construct the association model between multi-omics features and clinical phenotypes.
Gut-Heart Axis Mechanistic Correlation: Gut Microbiome Composition vs. Circulating Metabolites/Inflammatory Proteins
Gut microbiome: 16S rRNA gene sequencing (Illumina MiSeq platform)，Circulating metabolites: Liquid chromatography-tandem mass spectrometry (LC-MS/MS)，Inflammatory proteins: Multiplex immunoassay (Luminex platform)Spearman correlation analysis (for microbial relative abundance vs. metabolite/protein concentration)；Mantel test (for overall microbiome composition vs. metabolite/protein profiles).
Click on the lead sponsor to view all of their trials.
Xinjiang Medical University
Lead sponsor
First Affiliated Hospital of Xinjiang Medical University
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options:
