An observational study in Heart Failure, sponsored by The First Affiliated Hospital of Bengbu Medical University. Not yet recruiting. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-05-06.
Sponsored by The First Affiliated Hospital of Bengbu Medical University · Observational
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.
Heart failure (HF) remains a leading cause of morbidity, hospitalization, and mortality worldwide. Traditional risk assessment tools, such as left ventricular ejection fraction (LVEF) and NT-proBNP levels, are widely used but have limitations in early identification of high-risk patients, particularly those with subclinical myocardial injury or conduction abnormalities. Recent advances suggest that high-frequency QRS (HF-QRS) signal abnormalities extracted from standard 12-lead ECGs can sensitively detect microstructural myocardial changes, such as fibrosis and conduction disruption, earlier than conventional markers. Additionally, circulating biomarkers associated with myocardial fibrosis (including PIIINP, Galectin-3, and sST2) have emerged as promising indicators of cardiac remodeling and disease progression.
The STRIVE (Stratification Risk Via HF-QRS and Fibrosis Biomarkers in Heart Failure) Cohort is a prospective, multicenter observational study designed to systematically evaluate the prognostic significance of HF-QRS parameters and fibrosis biomarkers in patients with chronic heart failure (CHF).
Approximately 1500 patients with clinically stable CHF will be enrolled across multiple centers and followed for 18 months. Baseline data collection will include demographics, medical history, laboratory measures, standard echocardiographic parameters, HF-QRS signal analysis, and serum fibrosis biomarker levels (measured by ELISA). Clinical outcomes including cardiovascular death, first HF rehospitalization, malignant arrhythmia events, and all-cause rehospitalization will be prospectively recorded.
The study aims to assess the independent and incremental predictive value of HF-QRS and fibrosis biomarkers over traditional risk models. Furthermore, a multivariable prediction model integrating electrophysiological and molecular markers will be developed and internally validated to support dynamic risk stratification and personalized management strategies for CHF patients.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's planned enrollment of 1,500 is above the median of 200 across 1,679 observational studies indexed under Heart Failure.
Browse Heart Failure studies →The First Affiliated Hospital of Bengbu Medical University is the lead sponsor of 16 studies on the registry; 11 are open to participants now.
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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).
Inclusion Criteria：
The Main Exclusion Criteria:
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.
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
All-Cause Mortality
Death from any cause recorded during the 18-month follow-up period.
Time frame: Up to 18 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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The First Affiliated Hospital of Bengbu Medical University