Heart FailureCURE-HFNCT06939985
Cardiometabolic evalUation REgistry of Heart Failure
An observational study of Heart Failure and Metabolic Cardiovascular Syndrome, run by Ruijin Hospital at 1 site in China.
Trial summary
This is a combined retrospective-prospective observational cohort study investigating the role of systemic and local cardiometabolic risk factors in cardiac structural/functional remodeling and clinical outcomes among heart failure (HF) patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Metabolic Cardiovascular Syndrome, Metabolic Diseases
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2015to 31 May 2030
- How long will I take part?
- 5 Years
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is a combination of retrospective and prospective cohort. Ambulatory and hospitalized patients with chronic HF (NYHA II-IV) across all ejection fraction phenotypes are consecutively enrolled.
Who may be able to join
- Age ≥ 18 years
- Chronic HF (NYHA II~IV), including:
- HFrEF (HF with reduced ejection fraction): ① HF symptoms±signs ; ② LVEF≤40%.
- HFimpEF (HF with improved ejection fraction): ① HF symptoms±signs; ② previous LVEF ≤ 40% and a follow-up measurement of LVEF >40%.
- HFmrEF (HF with mildly reduced ejection fraction): ① HF symptoms±signs; ② LVEF 41%~49%.
- HFpEF (HF with preserved ejection fraction): ① HF symptoms±signs; ② LVEF ≥50%; ③ objective evidence of cardiac structural and/or functional abnormalities consistent with the presence of LV diastolic dysfunction/raised LV filling pressures, including raised natriuretic peptide.
Who cannot join
- Estimated survival ≤ 1 year.
- Pregnant or lactation, or have the intention to give birth within one year.
- Poor compliance, unable to follow-up.
- Mental or physical status not allowing written informed consent.
- Unwillingness to give informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, 200025
Chendie Yang, M.D., Ph.D., 0086-21-64370045-671503, yangcd1029@163.com
Xiaoqun Wang, M.D., Ph.D.
About this study
Official title: Cardiometabolic Risk Factors and Clinical Outcomes in Heart Failure: An Observational Cohort Study
This is a combined retrospective-prospective observational cohort study investigating the role of systemic and local cardiometabolic risk factors in cardiac structural/functional remodeling and clinical outcomes among heart failure (HF) patients. The study integrates retrospective clinical data (from the past 10 years) and prospective longitudinal follow-up (5 years) of HF patients across HF with reduced (HFrEF), mildly-reduced (HFmrEF), preserved (HFpEF) and improved ejection fraction (HFimpEF) phenotypes. Systemic metabolic factors (e.g., blood lipid profiles, glycemic levels, insulin resistance) and local factors (e.g., epicardial adipose tissue [EAT], perivascular adipose tissue [PVAT]) will be analyzed for their associations with changes in cardiac geometrics and function, dynamic transitions between HF phenotypes, as well as the occurrence of major adverse cardiovascular events (MACEs). The study seeks to advance risk stratification by integrated evaluation of cardiometabolic profiles so as to refine personalized cures in HF management.
Read the detailed description
This is a combined retrospective-prospective observational cohort study aiming to elucidate the interplay between systemic/localized cardiometabolic risk factors and their impact on myocardial remodeling, cardiac function, and clinical trajectories in heart failure (HF) patients. By harmonizing retrospective clinical data spanning the past decade with a 5-year prospective longitudinal follow-up, the study encompasses all HF phenotypes, including reduced (HFrEF), mildly reduced (HFmrEF), preserved (HFpEF), and improved ejection fraction (HFimpEF), to capture the full spectrum of disease heterogeneity. Systemic metabolic dysregulation, such as dyslipidemia, impaired glucose metabolism, obesity and other metabolites assessed by mass spectrometry (MS), will be evaluated alongside localized factors, such as epicardial adipose tissue (EAT), perivascular adipose tissue (PVAT) quantified by advanced imaging modalities (cardiac MRI or CT). These factors will be correlated with changes in cardiac geometry (e.g., left ventricular mass, chamber dimensions, wall thickness) and function (e.g., ejection fraction, strain imaging, diastolic parameters), dynamic transitions between HF phenotypes (e.g., HFrEF to HFimpEF), as well as the occurrence of major adverse cardiovascular events (MACEs), defined as a composite of HF re-hospitalization and cardiovascular death. The prospective cohort will undergo standardized baseline assessments (blood biomarkers, echocardiography, cardiac CT or MRI) followed by routine clinical, biochemical and imaging evaluations at least 3-month intervals. Retrospective data will be extracted from electronic health records, including historical imaging studies, laboratory results, and event documentation, ensuring a robust sample size (target n≈3500 retrospective; n≈1200 prospective) for stratified analyses by HF phenotype, sex, and metabolic risk tertiles. Advanced statistical approaches, including multivariable regression analysis, multivariable Cox proportional hazards models and machine learning algorithms, will identify independent predictors for cardiac remodeling, functional alterations, HF phenotype transitions and MACEs. Ethical approval and informed consent are obtained for prospective participants, with retrospective data anonymized to ensure privacy. This study is expected to refine risk stratification tools by integrating metabolic imaging biomarkers and biochemical profiles, ultimately guiding personalized therapeutic cures for HF patients.
- Keywords
- heart failure, cardiometabolic risk factors, epicardial adipose tissue, cardiac remodeling, heart failure phenotypes, major adverse cardiovascular events
- Medical subject headings
- Heart Failure, Metabolic Syndrome, Metabolic Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in cardiac function
Changes in ejection fraction (EF) measured by echocardiography or cardiac MRI at baseline and during follow-up.
Measured: 12 months
Major cardiovascular events (MACEs)
A composite endpoint of HF re-hospitalizaion and cardiovascular death during follow-up
Measured: 5 years
Secondary outcomes (17)
HF re-hospitalization
The occurrence of protocol-adjudicated, unplanned hospitalization (≥24 hours requiring intravenous therapy for worsening HF, validated by symptomatic/hemodynamic criteria and biomarker/imaging evidence) during follow-up.
Measured: 5 years
Cardiovascular death
The occurrence of cardiovascular death during follow-up.
Measured: 5 years
All-cause mortality
The occurrence of death during follow-up
Measured: 5 years
Dynamic transition among HF phenotypes
The occurrence of transition among HF phenotypes (HFrEF, HFimpEF, HFmrEF, HFpEF) measured by echocardiography or cardiac MRI at baseline and during follow-up
Measured: 12 months
Changes in cardiac diastolic function
Changes in diastolic function (E/e' and E/A), measured by echocardiography at baseline an follow-up
Measured: 12 months
Changes in cardiac regional myocardial contractile function
Changes in wall motion score index (WMSI) measured by echocardiography at baseline and follow-up
Measured: 12 months
Changes in left ventricular strain
Changes in left ventricular strain measured by echocardiography or cardiac MR at baseline and during follow-up.
Measured: 12 months
Changes in left atrial strain
Changes in left atrial strain measured by echocardiography or cardiac MR at baseline and during follow-up.
Measured: 12 months
Changes in chamber dimensions
The changes in chamber dimensions analyzed by echocardiography or cardiac MRI at baseline and during follow-up
Measured: 12 months
Changes in left ventricular mass
The changes in cardiac left ventricular mass analyzed by echocardiography or cardiac MRI at baseline and during follow-up.
Measured: 12 months
Cardiac wall thickness
The changes in wall thickness analyzed by echocardiography or cardiac MRI at baseline and during follow-up.
Measured: 12 months
Changes in epicardial adipose tissue (EAT) volume
Changes in the volume of EAT measured by cardiac CT or MRI and quantification analysis at baseline and during follow-up.
Measured: 12 months
Changes in epicardial adipose tissue (EAT) density
Changes in the density of EAT measured by cardiac CT or MRI and quantification analysis at baseline and during follow-up.
Measured: 12 months
Changes in epicardial adipose tissue (EAT) distribution
Changes in the distribution of EAT measured by cardiac CT or MRI and quantification analysis at baseline and during follow-up.
Measured: 12 months
Changes in perivascular adipose tissue (PVAT) volume
Changes in the volume of PVAT measured by coronary CT angiography and quantification analysis at baseline and during follow-up.
Measured: 12 months
Changes in perivascular adipose tissue (PVAT) density
Changes in the density of PVAT measured by coronary CT angiography and quantification analysis at baseline and during follow-up.
Measured: 12 months
Changes in perivascular adipose tissue (PVAT) distribution
Changes in the distribution of PVAT measured by coronary CT angiography and quantification analysis at baseline and during follow-up.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start1 Jan 2015
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2030 (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.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- 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
- 5,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RUIYAN ZHANG, Ruijin Hospital
- Investigators
- Ruiyan Zhang, M.D., Ph.D., Principal investigator, Ruijin HospitalXiaoqun Wang, M.D., Ph.D., Study chair, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06939985
- Sponsor's protocol ID
- RJH-CUREHF
- Acronym
- CURE-HF
- Status last verified
- Apr 2025
- First submitted
- 8 Apr 2025
- Last updated
- 23 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiometabolic Risk Factors and Clinical Outcomes in Heart Failure: An Observational Cohort Study
- ClinicalTrials.gov ID
- NCT06939985
- Acronym / sponsor ID
- CURE-HF / RJH-CUREHF
- Keywords
- heart failure, cardiometabolic risk factors, epicardial adipose tissue, cardiac remodeling, heart failure phenotypes, major adverse cardiovascular events
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2030 (estimated)
- First posted
- 23 Apr 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 is a combined retrospective-prospective observational cohort study investigating the role of systemic and local cardiometabolic risk factors in cardiac structural/functional remodeling and clinical outcomes among heart failure (HF) patients. The study integrates retrospective clinical data (from the past 10 years) and prospective longitudinal follow-up (5 years) of HF patients across HF with reduced (HFrEF), mildly-reduced (HFmrEF), preserved (HFpEF) and improved ejection fraction (HFimpEF) phenotypes. Systemic metabolic factors (e.g., blood lipid profiles, glycemic levels, insulin resistance) and local factors (e.g., epicardial adipose tissue [EAT], perivascular adipose tissue [PVAT]) will be analyzed for their associations with changes in cardiac geometrics and function, dynamic transitions between HF phenotypes, as well as the occurrence of major adverse cardiovascular events (MACEs). The study seeks to advance risk stratification by integrated evaluation of cardiometabolic profiles so as to refine personalized cures in HF management.
Detailed description
This is a combined retrospective-prospective observational cohort study aiming to elucidate the interplay between systemic/localized cardiometabolic risk factors and their impact on myocardial remodeling, cardiac function, and clinical trajectories in heart failure (HF) patients. By harmonizing retrospective clinical data spanning the past decade with a 5-year prospective longitudinal follow-up, the study encompasses all HF phenotypes, including reduced (HFrEF), mildly reduced (HFmrEF), preserved (HFpEF), and improved ejection fraction (HFimpEF), to capture the full spectrum of disease heterogeneity. Systemic metabolic dysregulation, such as dyslipidemia, impaired glucose metabolism, obesity and other metabolites assessed by mass spectrometry (MS), will be evaluated alongside localized factors, such as epicardial adipose tissue (EAT), perivascular adipose tissue (PVAT) quantified by advanced imaging modalities (cardiac MRI or CT). These factors will be correlated with changes in cardiac geometry (e.g., left ventricular mass, chamber dimensions, wall thickness) and function (e.g., ejection fraction, strain imaging, diastolic parameters), dynamic transitions between HF phenotypes (e.g., HFrEF to HFimpEF), as well as the occurrence of major adverse cardiovascular events (MACEs), defined as a composite of HF re-hospitalization and cardiovascular death. The prospective cohort will undergo standardized baseline assessments (blood biomarkers, echocardiography, cardiac CT or MRI) followed by routine clinical, biochemical and imaging evaluations at least 3-month intervals. Retrospective data will be extracted from electronic health records, including historical imaging studies, laboratory results, and event documentation, ensuring a robust sample size (target n≈3500 retrospective; n≈1200 prospective) for stratified analyses by HF phenotype, sex, and metabolic risk tertiles. Advanced statistical approaches, including multivariable regression analysis, multivariable Cox proportional hazards models and machine learning algorithms, will identify independent predictors for cardiac remodeling, functional alterations, HF phenotype transitions and MACEs. Ethical approval and informed consent are obtained for prospective participants, with retrospective data anonymized to ensure privacy. This study is expected to refine risk stratification tools by integrating metabolic imaging biomarkers and biochemical profiles, ultimately guiding personalized therapeutic cures for HF patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a combination of retrospective and prospective cohort. Ambulatory and hospitalized patients with chronic HF (NYHA II-IV) across all ejection fraction phenotypes are consecutively enrolled.
Key inclusion criteria (6 listed)
- Age ≥ 18 years
- Chronic HF (NYHA II~IV), including:
Key exclusion criteria (5 listed)
- Estimated survival ≤ 1 year.
- Pregnant or lactation, or have the intention to give birth within one year.
- Poor compliance, unable to follow-up.
- Mental or physical status not allowing written informed consent.
- Unwillingness to give informed consent.
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
Changes in cardiac function
Time frame: 12 months
Changes in ejection fraction (EF) measured by echocardiography or cardiac MRI at baseline and during follow-up.
Major cardiovascular events (MACEs)
Time frame: 5 years
A composite endpoint of HF re-hospitalizaion and cardiovascular death during follow-up
17 secondary outcomes
HF re-hospitalization
Time frame: 5 years
Cardiovascular death
Time frame: 5 years
All-cause mortality
Time frame: 5 years
Dynamic transition among HF phenotypes
Time frame: 12 months
Changes in cardiac diastolic function
Time frame: 12 months
Changes in cardiac regional myocardial contractile function
Time frame: 12 months
Changes in left ventricular strain
Time frame: 12 months
Changes in left atrial strain
Time frame: 12 months
Changes in chamber dimensions
Time frame: 12 months
Changes in left ventricular mass
Time frame: 12 months
Cardiac wall thickness
Time frame: 12 months
Changes in epicardial adipose tissue (EAT) volume
Time frame: 12 months
Changes in epicardial adipose tissue (EAT) density
Time frame: 12 months
Changes in epicardial adipose tissue (EAT) distribution
Time frame: 12 months
Changes in perivascular adipose tissue (PVAT) volume
Time frame: 12 months
Changes in perivascular adipose tissue (PVAT) density
Time frame: 12 months
Changes in perivascular adipose tissue (PVAT) distribution
Time frame: 12 months
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 23 Apr 2025.
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
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.
Ruiyan Zhang, M.D., Ph.D. principal investigator
Ruijin Hospital
Xiaoqun Wang, M.D., Ph.D. study chair
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Metabolic Cardiovascular Syndrome, run by Ruijin Hospital at 1 site in China.
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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Chendie Yang, M.D., Ph.D. (0086-21-64370045-671503, yangcd1029@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in cardiac function (time frame: 12 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 23 Apr 2025.