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Clinical Trials in China / NCT07355088
Starting soon Observational

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

NCT07355088 · tracked via the Priya Life Science China tracker
Sponsor
Xinjiang Medical University
Phase
Observational
Started
2026-01-01
Last updated
2026-01-21

Condition(s) studied

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
Accepted
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).

Primary outcome measure(s)

  • 1-Year Composite Endpoint by HF Subtype (Heart Failure Rehospitalization or All-Cause Death) — 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.

Trial sites (1)

FacilityCityRegionStatus
The First Affiliated Hospital of Xinjiang Medical University Xinjiang Urumqi

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Other trials for the same condition

Fecal Microbiota Transplantation for Elderly Patients With HFpEF: A Randomized Controlled Trial Starting soon
A Study to Investigate CV Outcomes With Elecoglipron Compared With Placebo in Adult Participants With HFpEF or HFmrEF Recruiting
A Study of IBI362 in Subjects With HFpEF or HFmrEF Combined With Obesity Active, not recruiting
Vericiguat Use and Incident Atrial Fibrillation in Chronic Heart Failure Active, not recruiting
A Phase I/II Clinical Trial of Intramyocardial Injection of HucMSCs for the Treatment of Chronic Heart Failure Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07355088 on ClinicalTrials.gov ↗ ← All trials in China