Cardiometabolic evalUation REgistry of Heart Failure (CURE-HF)

April 18, 2025 updated by: RUIYAN ZHANG, Ruijin Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Chendie Yang, M.D., Ph.D.
  • Phone Number: 0086-21-64370045-671503
  • Email: yangcd1029@163.com

Study Contact Backup

  • Name: Xiaoqun Wang, M.D., Ph.D.
  • Phone Number: 0086-21-64370045-671605
  • Email: wangxq@shsmu.edu.cn

Study Locations

  • China
      • Shanghai, China, 200025
        • Recruiting
        • Ruijin Hospital, Shanghai JiaoTong University School of Medicine
        • Principal Investigator:
          • Xiaoqun Wang, M.D., Ph.D.
        • Sub-Investigator:
          • Shuo Feng, M.D., Ph.D.
        • Contact:
          • Chendie Yang, M.D., Ph.D.
          • Phone Number: 0086-21-64370045-671503
          • Email: yangcd1029@163.com
        • Sub-Investigator:
          • Chendie Yang, M.D., Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
12 months
Major cardiovascular events (MACEs)
Time Frame: 5 years
A composite endpoint of HF re-hospitalizaion and cardiovascular death during follow-up
5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
5 years
Cardiovascular death
Time Frame: 5 years
The occurrence of cardiovascular death during follow-up.
5 years
All-cause mortality
Time Frame: 5 years
The occurrence of death during follow-up
5 years
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
12 months
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
12 months
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
12 months
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.
12 months
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.
12 months
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
12 months
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.
12 months
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 months
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.
12 months
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.
12 months
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.
12 months
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.
12 months
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.
12 months
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ruijin Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ruiyan Zhang, M.D., Ph.D., Ruijin Hospital
  • Study Chair: Xiaoqun Wang, M.D., Ph.D., Ruijin Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 8, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 23, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 23, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RJH-CUREHF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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