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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
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.

Chendie Yang, M.D., Ph.D. contact

0086-21-64370045-671503

yangcd1029@163.com

Xiaoqun Wang, M.D., Ph.D. contact

0086-21-64370045-671605

wangxq@shsmu.edu.cn

China1 site, 1 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.

    Recruiting

Other trials in China

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.

  1. Changes in cardiac function

    Changes in ejection fraction (EF) measured by echocardiography or cardiac MRI at baseline and during follow-up.

    Measured: 12 months

  2. Major cardiovascular events (MACEs)

    A composite endpoint of HF re-hospitalizaion and cardiovascular death during follow-up

    Measured: 5 years

Secondary outcomes (17)
  1. 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

  2. Cardiovascular death

    The occurrence of cardiovascular death during follow-up.

    Measured: 5 years

  3. All-cause mortality

    The occurrence of death during follow-up

    Measured: 5 years

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. Changes in chamber dimensions

    The changes in chamber dimensions analyzed by echocardiography or cardiac MRI at baseline and during follow-up

    Measured: 12 months

  10. 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

  11. Cardiac wall thickness

    The changes in wall thickness analyzed by echocardiography or cardiac MRI at baseline and during follow-up.

    Measured: 12 months

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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.

  1. First posted23 Apr 2025
  2. Study start1 Jan 2015
  3. Primary completion31 May 2027 (estimated)
  4. Study completion31 May 2030 (estimated)

Resources

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
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

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.

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