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NCT06959186Not yet recruiting

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

High-Frequency QRS and Fibrosis Biomarkers for Risk Stratification in Chronic Heart Failure: A Multicenter Prospective Cohort Study

Source: ClinicalTrials.gov · Last updated 6 May 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
1500 (estimated)
First submitted
28 Apr 2025
Start date
30 Jun 2025
Primary completion date
31 Dec 2026
Lead sponsor
The First Affiliated Hospital of Bengbu Medical University
NCT number
NCT06959186

What you commit to

  • Study type: Observational
  • Planned participants: 1500
  • From 30 Jun 2025 to the primary completion date, 31 Dec 2026
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

  • 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)

Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.