Precision Subtyping and Prognostic Study of Heart Failure Based on Multi-Omics Integration and Clinical Indicators: A Prospective Single-Center Cohort Study (HF-MultiOmics)

January 12, 2026 updated by: Xiang Xie, Xinjiang Medical University
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.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

This prospective single-center cohort study focuses on chronic heart failure (CHF) patients (HFrEF, HFmrEF, HFpEF) and healthy controls, with the core objective of establishing a precision risk stratification model for CHF via multi-omics-clinical integration.

Study Design & Enrollment Participants: 400 CHF patients (meeting 2022 ESC HF guidelines) and 200 age/gender-matched healthy controls (no cardiovascular disease history). Exclusion criteria include acute decompensated HF, end-stage renal disease, active malignancies, and recent antibiotic use (to avoid gut microbiome interference).

Recruitment: Conducted at The First Affiliated Hospital of Xinjiang Medical University over 12 months; eligible participants will provide written informed consent prior to enrollment.

Data & Sample Collection

Baseline:

Clinical data: NYHA functional class, NT-proBNP, echocardiography (LVEF, LVGLS), cardiac CT (EAT density/volume); Multi-omics samples: Plasma (proteome via Olink, metabolome via LC-MS), blood (genome via microarray), feces (gut microbiome via 16S rRNA sequencing; shotgun metagenomics for 200 patients); Follow-up: 3/6/12-month visits to collect clinical outcomes (rehospitalization, mortality), KCCQ quality-of-life scores, and dynamic multi-omics samples (only for SGLT2 inhibitor-treated patients).

Key Analyses Multi-omics characterization: Identify phenotype-specific molecular signatures (e.g., HFpEF-related metabolic profiles) via differential expression and correlation network analysis; Mechanistic exploration: Link gut microbiome composition to circulating metabolites/inflammatory proteins to clarify the "gut-heart axis" in CHF; Model construction: Integrate multi-omics and clinical/imaging indicators to build 4 prediction models (clinical-only, single-omics, multi-omics, integrated), with validation via Harrell's C-statistic and time-dependent ROC.

Quality Control Biological samples: Labeled with unique IDs, stored at -80°C; Imaging data: Independent review by 2 cardiologists (third-party arbitration for discrepancies); Data management: REDCap platform for electronic data capture; independent Data Monitoring Committee (DMC) reviews progress/safety every 6 months.

Study Type

Observational

Enrollment (Estimated)

600

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 Contact Backup

Study Locations

  • China
    • Urumqi
      • Xinjiang, Urumqi, China, 831100
        • The First Affiliated Hospital of Xinjiang Medical University
        • Contact:
        • Contact:
        • Sub-Investigator:
          • anni ma, BM
        • Principal Investigator:
          • ailiman mahemuti, MD
        • Principal Investigator:
          • xiang xie, MD
        • Sub-Investigator:
          • refukaiti abuduhalike, MD
        • Sub-Investigator:
          • aihaidan abuduwayiti, MD
        • Sub-Investigator:
          • li zhao, MD
        • Sub-Investigator:
          • yujun guo, MM
        • Sub-Investigator:
          • zhiying wen, MM
        • Sub-Investigator:
          • yanxiao li, MM

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:(1)For chronic heart failure (CHF) patients:1.Meet the 2022 European Society of Cardiology (ESC) diagnostic criteria for CHF, classified into heart failure with reduced ejection fraction (HFrEF), heart failure with mildly reduced ejection fraction (HFmrEF), and heart failure with preserved ejection fraction (HFpEF) per ESC guidelines;2.Aged 18 to 80 years (inclusive);3.Able to provide written informed consent independently (or via a legal guardian if cognitively impaired, with a Mini-Mental State Examination [MMSE] score ≥ 24).

(2)For healthy controls:1.No history of cardiovascular disease, confirmed by medical history review and baseline echocardiography;2.Aged 18 to 80 years (inclusive), matched 1:2 with CHF patients by age and gender;3.Able to provide written informed consent.

Exclusion Criteria:(1)Acute decompensated heart failure (admitted for acute HF exacerbation within 72 hours prior to enrollment);(2)End-stage renal disease, defined as an estimated glomerular filtration rate (eGFR) < 15 mL/min/1.73m² (confirmed by serum creatinine testing);(3)Active malignancies (receiving systemic treatment within 6 months prior to enrollment) or severe systemic diseases (e.g., severe liver failure, active autoimmune diseases);(4)Antibiotic use within 2 weeks prior to enrollment (may interfere with gut microbiome analysis);(5)Inability to complete 12-month follow-up (e.g., planned long-term overseas residence) or provide required biological samples (e.g., venous blood, fecal samples).

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
Chronic Heart Failure Patients
Enroll 400 participants meeting 2022 ESC guidelines for chronic heart failure (including HFrEF, HFmrEF, HFpEF). Collect clinical data, multi-omics samples, and imaging indicators at baseline; follow up for 12 months to track outcomes and dynamic changes.
Healthy Controls
Enroll 200 age/gender-matched participants with no history of cardiovascular disease. Collect baseline clinical data and multi-omics samples for comparative analysis; follow up for 12 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1-Year Composite Endpoint by HF Subtype (Heart Failure Rehospitalization or All-Cause Death)
Time Frame: 12 months
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1-Year Heart Failure-Related Rehospitalization (Independent Endpoint)
Time Frame: 12 months
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.
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of Heart Failure Phenotype-Specific Molecular Signatures (Multi-Omics Biomarker Panel)
Time Frame: Baseline
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).
Baseline
Correlation Between Multi-Omics Profiles and Clinical Phenotypes of Heart Failure
Time Frame: Baseline
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.
Baseline
Gut-Heart Axis Mechanistic Correlation: Gut Microbiome Composition vs. Circulating Metabolites/Inflammatory Proteins
Time Frame: Baseline
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).
Baseline

Collaborators and Investigators

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

Sponsor

Xinjiang Medical University

Investigators

  • Study Director: ailiman mahemut, MD, First Affiliated Hospital of Xinjiang Medical University
  • Study Director: xiang xie, MD, First Affiliated Hospital of Xinjiang Medical University
  • Study Chair: refukait abuduhalike, MD, First Affiliated Hospital of Xinjiang Medical University
  • Study Chair: aihaidan abuduwayiti, MD, First Affiliated Hospital of Xinjiang Medical University
  • Study Chair: li zhao, MD, First Affiliated Hospital of Xinjiang Medical University
  • Study Chair: yujun guo, MM, First Affiliated Hospital of Xinjiang Medical University
  • Study Chair: zhiying wen, MM, First Affiliated Hospital of Xinjiang Medical University
  • Study Chair: yanxiao li, MM, Xinjiang Medical University

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 (Estimated)

January 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

December 29, 2025

First Submitted That Met QC Criteria

January 12, 2026

First Posted (Actual)

January 21, 2026

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 12, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • XJMU-HF-MultiOmics-2025-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This study involves human genetic resources and sensitive clinical data (including multi-omics profiles and patient follow-up information) of participants. According to the regulations on the management of human genetic resources in China and the informed consent agreement signed with participants (which does not include authorization for IPD sharing with external researchers), the individual participant data (IPD) will not be shared with other researchers to protect the privacy and rights of participants, and to comply with relevant national regulations.

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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