Risk Stratification Via HF-QRS and Fibrosis Biomarkers in Heart Failure

NCT06959186 | Not Yet Recruiting

• 1 other identifier: BBMUFH20250428
• Study Type: observational
• Target: 1,500
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to evaluate whether high-frequency QRS (HF-QRS) signal parameters and circulating myocardial fibrosis biomarkers (such as PIIINP, Galectin-3, and sST2) can improve risk stratification in patients with chronic heart failure (CHF). In this prospective, multicenter cohort study (STRIVE cohort), patients with CHF will be enrolled and followed for 18 months. Clinical data, routine heart function measures (such as NT-proBNP and LVEF), HF-QRS features from standard 12-lead ECG, and serum fibrosis biomarker levels will be collected. The study will assess the association of HF-QRS abnormalities and fibrosis biomarker levels with major clinical outcomes, including cardiovascular mortality, first heart failure-related rehospitalization, malignant arrhythmia events, all-cause rehospitalization and mortality. By integrating electrophysiological and molecular markers, this research aims to develop a novel, non-invasive predictive model to support early risk identification and personalized management of heart failure patients.

Conditions

Heart Failure

Keywords

Heart Failure; Myocardial Fibrosis; high-frequency QRS; biomarker; rehospitalization; mortality

Outcome Measures

Primary Outcomes (2)

• Composite of Cardiovascular mortality, First Heart Failure-related Rehospitalization, Malignant Arrhythmia, and All-Cause Rehospitalization

  A composite outcome including cardiovascular mortality, first heart failure-related rehospitalization, malignant arrhythmia events (ventricular tachycardia, ventricular fibrillation, torsades de pointes), and all-cause rehospitalization, assessed during the 18-month follow-up period.

  Up to 18 months

• All-Cause Mortality

  Death from any cause recorded during the 18-month follow-up period.

  Up to 18 months

Study Arms (1)

Chronic Heart Failure Patients

Participants diagnosed with chronic heart failure (CHF), classified based on left ventricular ejection fraction (LVEF) into heart failure with reduced ejection fraction (HFrEF), heart failure with mildly reduced ejection fraction (HFmrEF), or heart failure with preserved ejection fraction (HFpEF) groups. All participants receive standard-of-care heart failure management according to clinical guidelines. No investigational intervention is assigned; this is an observational cohort.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults aged 18-85 years diagnosed with chronic heart failure (CHF), classified into HFrEF, HFmrEF, and HFpEF according to LVEF, receiving guideline-directed medical therapy (GDMT).

You may qualify if:

• Age ≥18 years and ≤85 years
• Diagnosis of chronic heart failure (CHF) based on ESC 2021 and AHA/ACC/HFSA 2022 guidelines
• Presence of typical symptoms (e.g., exercise intolerance, dyspnea, orthopnea, paroxysmal nocturnal dyspnea, or fatigue) and signs (e.g., lower extremity edema, jugular venous distension, pulmonary rales)
• Elevated NT-proBNP (\>125 pg/mL, adjusted for BMI if \>25 kg/m²)
• Evidence of structural or functional cardiac abnormalities by echocardiography (LVEF ≤50%, E/e' \>14, e' \<9 cm/s, LV hypertrophy, or left atrial enlargement)
• For HFpEF patients (LVEF ≥50%), at least one additional echocardiographic abnormality is required

You may not qualify if:

• End-stage renal disease requiring dialysis
• Severe chronic pulmonary disease (e.g., moderate-to-severe COPD, pulmonary fibrosis)
• Active malignancy or life expectancy \<1 year
• Severe anemia (Hb \<8 g/dL) or uncontrolled thyroid dysfunction
• \. Cardiogenic shock or need for mechanical ventilatory support 5. Severe cognitive impairment, psychiatric illness, or inability to comply with study procedures 6. Other non-cardiac causes that may mimic heart failure symptoms (e.g., advanced liver cirrhosis)

Sponsors & Collaborators

• The First Affiliated Hospital of Bengbu Medical University: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Prof. Tang, Bi, PhD

CONTACT

86 0552-3086107; bitang2000@163.com

Dr. Cheng, Wenke, PhD

CONTACT

86 0552-3086107; chengwenke@bbmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: May 6, 2025
• Study Start: June 30, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share