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NCT Number: NCT06939985

Cardiometabolic evalUation REgistry of Heart Failure

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, 200025, China

Location status: Recruiting

Location contact

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

CONTACT

[email protected]

0086-21-64370045-671503

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

SUB_INVESTIGATOR

Shuo Feng, M.D., Ph.D.

SUB_INVESTIGATOR

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

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. Major cardiovascular events (MACEs)

    Time frame: 5 years

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

Secondary outcomes

  1. HF re-hospitalization

    Time frame: 5 years

    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.

  2. Cardiovascular death

    Time frame: 5 years

    The occurrence of cardiovascular death during follow-up.

  3. All-cause mortality

    Time frame: 5 years

    The occurrence of death during follow-up

  4. Dynamic transition among HF phenotypes

    Time frame: 12 months

    The occurrence of transition among HF phenotypes (HFrEF, HFimpEF, HFmrEF, HFpEF) measured by echocardiography or cardiac MRI at baseline and during follow-up

  5. Changes in cardiac diastolic function

    Time frame: 12 months

    Changes in diastolic function (E/e' and E/A), measured by echocardiography at baseline an follow-up

  6. Changes in cardiac regional myocardial contractile function

    Time frame: 12 months

    Changes in wall motion score index (WMSI) measured by echocardiography at baseline and follow-up

  7. Changes in left ventricular strain

    Time frame: 12 months

    Changes in left ventricular strain measured by echocardiography or cardiac MR at baseline and during follow-up.

  8. Changes in left atrial strain

    Time frame: 12 months

    Changes in left atrial strain measured by echocardiography or cardiac MR at baseline and during follow-up.

  9. Changes in chamber dimensions

    Time frame: 12 months

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

  10. Changes in left ventricular mass

    Time frame: 12 months

    The changes in cardiac left ventricular mass analyzed by echocardiography or cardiac MRI at baseline and during follow-up.

  11. Cardiac wall thickness

    Time frame: 12 months

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

  12. Changes in epicardial adipose tissue (EAT) volume

    Time frame: 12 months

    Changes in the volume of EAT measured by cardiac CT or MRI and quantification analysis at baseline and during follow-up.

  13. Changes in epicardial adipose tissue (EAT) density

    Time frame: 12 months

    Changes in the density of EAT measured by cardiac CT or MRI and quantification analysis at baseline and during follow-up.

  14. Changes in epicardial adipose tissue (EAT) distribution

    Time frame: 12 months

    Changes in the distribution of EAT measured by cardiac CT or MRI and quantification analysis at baseline and during follow-up.

  15. Changes in perivascular adipose tissue (PVAT) volume

    Time frame: 12 months

    Changes in the volume of PVAT measured by coronary CT angiography and quantification analysis at baseline and during follow-up.

  16. Changes in perivascular adipose tissue (PVAT) density

    Time frame: 12 months

    Changes in the density of PVAT measured by coronary CT angiography and quantification analysis at baseline and during follow-up.

  17. Changes in perivascular adipose tissue (PVAT) distribution

    Time frame: 12 months

    Changes in the distribution of PVAT measured by coronary CT angiography and quantification analysis at baseline and during follow-up.

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

0086-21-64370045-671503

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

CONTACT

[email protected]

0086-21-64370045-671605

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

Cardiometabolic Risk Factors and Clinical Outcomes in Heart Failure: An Observational Cohort Study

Acronym: CURE-HF

Important dates

Study start
2015
Primary completion
2027
Study completion
2030
First posted
Apr 23, 2025
Registry last updated
Apr 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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