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

ConditionHeart Failure
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-85
SponsorThe First Affiliated Hospital of Bengbu Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial 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).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,500 Participants
are grouped into 1 trial group
Group A: Chronic Heart Failure Patients

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to 18 months
2

All-Cause Mortality

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

Time frame
Up to 18 months

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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