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Cardiometabolic evalUation REgistry of Heart Failure

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06939985
Acronym
CURE-HF
Enrollment
5000
Registered
2025-04-23
Start date
2015-01-01
Completion date
2030-05-31
Last updated
2025-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Metabolic Cardiovascular Syndrome, Metabolic Diseases

Keywords

heart failure, cardiometabolic risk factors, epicardial adipose tissue, cardiac remodeling, heart failure phenotypes, major adverse cardiovascular events

Brief 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. 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.

Interventions

None listed

Sponsors

Ruijin Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Age ≥ 18 years 2. 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

1. Estimated survival ≤ 1 year. 2. Pregnant or lactation, or have the intention to give birth within one year. 3. Poor compliance, unable to follow-up. 4. Mental or physical status not allowing written informed consent. 5. Unwillingness to give informed consent.

Design outcomes

Primary

MeasureTime frameDescription
Changes in cardiac function12 monthsChanges in ejection fraction (EF) measured by echocardiography or cardiac MRI at baseline and during follow-up.
Major cardiovascular events (MACEs)5 yearsA composite endpoint of HF re-hospitalizaion and cardiovascular death during follow-up

Secondary

MeasureTime frameDescription
All-cause mortality5 yearsThe occurrence of death during follow-up
Dynamic transition among HF phenotypes12 monthsThe occurrence of transition among HF phenotypes (HFrEF, HFimpEF, HFmrEF, HFpEF) measured by echocardiography or cardiac MRI at baseline and during follow-up
Changes in cardiac diastolic function12 monthsChanges in diastolic function (E/e' and E/A), measured by echocardiography at baseline an follow-up
Changes in cardiac regional myocardial contractile function12 monthsChanges in wall motion score index (WMSI) measured by echocardiography at baseline and follow-up
Changes in left ventricular strain12 monthsChanges in left ventricular strain measured by echocardiography or cardiac MR at baseline and during follow-up.
Changes in left atrial strain12 monthsChanges in left atrial strain measured by echocardiography or cardiac MR at baseline and during follow-up.
Changes in chamber dimensions12 monthsThe changes in chamber dimensions analyzed by echocardiography or cardiac MRI at baseline and during follow-up
HF re-hospitalization5 yearsThe 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.
Cardiac wall thickness12 monthsThe changes in wall thickness analyzed by echocardiography or cardiac MRI at baseline and during follow-up.
Changes in epicardial adipose tissue (EAT) volume12 monthsChanges in the volume of EAT measured by cardiac CT or MRI and quantification analysis at baseline and during follow-up.
Changes in epicardial adipose tissue (EAT) density12 monthsChanges in the density of EAT measured by cardiac CT or MRI and quantification analysis at baseline and during follow-up.
Changes in epicardial adipose tissue (EAT) distribution12 monthsChanges in the distribution of EAT measured by cardiac CT or MRI and quantification analysis at baseline and during follow-up.
Changes in perivascular adipose tissue (PVAT) volume12 monthsChanges in the volume of PVAT measured by coronary CT angiography and quantification analysis at baseline and during follow-up.
Changes in perivascular adipose tissue (PVAT) density12 monthsChanges in the density of PVAT measured by coronary CT angiography and quantification analysis at baseline and during follow-up.
Changes in perivascular adipose tissue (PVAT) distribution12 monthsChanges in the distribution of PVAT measured by coronary CT angiography and quantification analysis at baseline and during follow-up.
Changes in left ventricular mass12 monthsThe changes in cardiac left ventricular mass analyzed by echocardiography or cardiac MRI at baseline and during follow-up.
Cardiovascular death5 yearsThe occurrence of cardiovascular death during follow-up.

Countries

China

Contacts

Primary ContactChendie Yang, M.D., Ph.D.
yangcd1029@163.com0086-21-64370045-671503
Backup ContactXiaoqun Wang, M.D., Ph.D.
wangxq@shsmu.edu.cn0086-21-64370045-671605

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026