Status:
NOT_YET_RECRUITING
Risk Stratification Via HF-QRS and Fibrosis Biomarkers in Heart Failure
Lead Sponsor:
The First Affiliated Hospital of Bengbu Medical University
Conditions:
Heart Failure
Eligibility:
All Genders
18-85 years
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 ...
Detailed Description
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 le...
Eligibility Criteria
Inclusion
- Inclusion Criteria：
- 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
- The Main Exclusion Criteria:
- 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
- 4\. 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)
Exclusion
Key Trial Info
Start Date :
June 30 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT06959186
Start Date
June 30 2025
End Date
December 31 2026
Last Update
May 6 2025
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