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

NCT07355088 | Not Yet Recruiting DMC

• 1 other identifier: XJMU-HF-MultiOmics-2025-001
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Heart Failure; Heart Failure With Reduced Ejection Fraction (HFrEF); Heart Failure With Preserved Ejection Fraction (HFPEF); Heart Failure With Mildly Reduced Ejection Fraction (HFmrEF)

Keywords

Chronic Heart Failure; Multi-omics; Gut-heart axis; SGLT2 inhibitors; Risk prediction model; Epicardial Adipose Tissue; Myocardial Strain

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (1)

• 1-Year Heart Failure-Related Rehospitalization (Independent Endpoint)

  12 months

Other Outcomes (3)

• Identification of Heart Failure Phenotype-Specific Molecular Signatures (Multi-Omics Biomarker Panel)

  Baseline

• Correlation Between Multi-Omics Profiles and Clinical Phenotypes of Heart Failure

  Baseline

• Gut-Heart Axis Mechanistic Correlation: Gut Microbiome Composition vs. Circulating Metabolites/Inflammatory Proteins

  Baseline

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• (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.

Sponsors & Collaborators

• Xinjiang Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Xinjiang Medical University

Xinjiang, Urumqi, 831100, China

Location

Related Publications (9)

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• Antonopoulos AS, Antoniades C. The role of epicardial adipose tissue in cardiac biology: classic concepts and emerging roles. J Physiol. 2017 Jun 15;595(12):3907-3917. doi: 10.1113/JP273049. Epub 2017 Mar 13.

  PMID: 28191635 BACKGROUND

• Medvedofsky D, Kebed K, Laffin L, Stone J, Addetia K, Lang RM, Mor-Avi V. Reproducibility and experience dependence of echocardiographic indices of left ventricular function: Side-by-side comparison of global longitudinal strain and ejection fraction. Echocardiography. 2017 Mar;34(3):365-370. doi: 10.1111/echo.13446. Epub 2017 Feb 9.

  PMID: 28185312 BACKGROUND

• Tang WH, Wang Z, Levison BS, Koeth RA, Britt EB, Fu X, Wu Y, Hazen SL. Intestinal microbial metabolism of phosphatidylcholine and cardiovascular risk. N Engl J Med. 2013 Apr 25;368(17):1575-84. doi: 10.1056/NEJMoa1109400.

  PMID: 23614584 BACKGROUND

• Cheng ML, Wang CH, Shiao MS, Liu MH, Huang YY, Huang CY, Mao CT, Lin JF, Ho HY, Yang NI. Metabolic disturbances identified in plasma are associated with outcomes in patients with heart failure: diagnostic and prognostic value of metabolomics. J Am Coll Cardiol. 2015 Apr 21;65(15):1509-20. doi: 10.1016/j.jacc.2015.02.018.

  PMID: 25881932 BACKGROUND

• Zhang X, Schulz BL, Punyadeera C. The current status of heart failure diagnostic biomarkers. Expert Rev Mol Diagn. 2016;16(4):487-500. doi: 10.1586/14737159.2016.1144474. Epub 2016 Feb 17.

  PMID: 26788983 BACKGROUND

• Shah S, Henry A, Roselli C, Lin H, Sveinbjornsson G, Fatemifar G, Hedman AK, Wilk JB, Morley MP, Chaffin MD, Helgadottir A, Verweij N, Dehghan A, Almgren P, Andersson C, Aragam KG, Arnlov J, Backman JD, Biggs ML, Bloom HL, Brandimarto J, Brown MR, Buckbinder L, Carey DJ, Chasman DI, Chen X, Chen X, Chung J, Chutkow W, Cook JP, Delgado GE, Denaxas S, Doney AS, Dorr M, Dudley SC, Dunn ME, Engstrom G, Esko T, Felix SB, Finan C, Ford I, Ghanbari M, Ghasemi S, Giedraitis V, Giulianini F, Gottdiener JS, Gross S, Guethbjartsson DF, Gutmann R, Haggerty CM, van der Harst P, Hyde CL, Ingelsson E, Jukema JW, Kavousi M, Khaw KT, Kleber ME, Kober L, Koekemoer A, Langenberg C, Lind L, Lindgren CM, London B, Lotta LA, Lovering RC, Luan J, Magnusson P, Mahajan A, Margulies KB, Marz W, Melander O, Mordi IR, Morgan T, Morris AD, Morris AP, Morrison AC, Nagle MW, Nelson CP, Niessner A, Niiranen T, O'Donoghue ML, Owens AT, Palmer CNA, Parry HM, Perola M, Portilla-Fernandez E, Psaty BM; Regeneron Genetics Center; Rice KM, Ridker PM, Romaine SPR, Rotter JI, Salo P, Salomaa V, van Setten J, Shalaby AA, Smelser DT, Smith NL, Stender S, Stott DJ, Svensson P, Tammesoo ML, Taylor KD, Teder-Laving M, Teumer A, Thorgeirsson G, Thorsteinsdottir U, Torp-Pedersen C, Trompet S, Tyl B, Uitterlinden AG, Veluchamy A, Volker U, Voors AA, Wang X, Wareham NJ, Waterworth D, Weeke PE, Weiss R, Wiggins KL, Xing H, Yerges-Armstrong LM, Yu B, Zannad F, Zhao JH, Hemingway H, Samani NJ, McMurray JJV, Yang J, Visscher PM, Newton-Cheh C, Malarstig A, Holm H, Lubitz SA, Sattar N, Holmes MV, Cappola TP, Asselbergs FW, Hingorani AD, Kuchenbaecker K, Ellinor PT, Lang CC, Stefansson K, Smith JG, Vasan RS, Swerdlow DI, Lumbers RT. Genome-wide association and Mendelian randomisation analysis provide insights into the pathogenesis of heart failure. Nat Commun. 2020 Jan 9;11(1):163. doi: 10.1038/s41467-019-13690-5.

  PMID: 31919418 BACKGROUND

• Ibrahim NE, Januzzi JL Jr. Beyond Natriuretic Peptides for Diagnosis and Management of Heart Failure. Clin Chem. 2017 Jan;63(1):211-222. doi: 10.1373/clinchem.2016.259564. Epub 2016 Oct 10.

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  PMID: 25398313 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

The retained biospecimens include:Venous blood samples (for genome, proteome, and metabolome analysis)、Fecal samples (for gut microbiome analysis).All samples will be stored at -80°C after collection and processing.

Study Officials

• ailiman mahemut, MD

  First Affiliated Hospital of Xinjiang Medical University

  STUDY DIRECTOR

• xiang xie, MD

  First Affiliated Hospital of Xinjiang Medical University

  STUDY DIRECTOR

• 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

  STUDY CHAIR

Central Study Contacts

yingying Zheng, MD

CONTACT

+8615214804944; zhengying527@163.com

anni ma, BM

CONTACT

+8615001677850; 1572938565@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: December 29, 2025
• First Posted: January 21, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: January 21, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)