Heart FailureSTRIVENCT06959186
Risk Stratification Via HF-QRS and Fibrosis Biomarkers in Heart Failure
An observational study of Heart Failure, run by The First Affiliated Hospital of Bengbu Medical University.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Heart Failure
- How many people
- 1,500 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
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- 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)
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: High-Frequency QRS and Fibrosis Biomarkers for Risk Stratification in Chronic Heart Failure: A Multicenter Prospective Cohort Study
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.
Read the 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 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.
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Myocardial Fibrosis, high-frequency QRS, biomarker, rehospitalization, mortality
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 18 months
All-Cause Mortality
Death from any cause recorded during the 18-month follow-up period.
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2025
- Study start30 Jun 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Bengbu Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06959186
- Sponsor's protocol ID
- BBMUFH20250428
- Acronym
- STRIVE
- Status last verified
- Apr 2025
- First submitted
- 28 Apr 2025
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Frequency QRS and Fibrosis Biomarkers for Risk Stratification in Chronic Heart Failure: A Multicenter Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06959186
- Acronym / sponsor ID
- STRIVE / BBMUFH20250428
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Myocardial Fibrosis, high-frequency QRS, biomarker, rehospitalization, mortality
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Bengbu Medical UniversityUniversity, hospital or other
- Study start
- 30 Jun 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (12 listed)
- 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Composite of Cardiovascular mortality, First Heart Failure-related Rehospitalization, Malignant Arrhythmia, and All-Cause Rehospitalization
Time frame: Up to 18 months
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.
All-Cause Mortality
Time frame: Up to 18 months
Death from any cause recorded during the 18-month follow-up period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by The First Affiliated Hospital of Bengbu Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prof. Tang, Bi, PhD (86 0552-3086107, bitang2000@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of Cardiovascular mortality, First Heart Failure-related Rehospitalization, Malignant Arrhythmia, and All-Cause Rehospitalization (time frame: Up to 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2025.