Cardiometabolic evalUation REgistry of Heart Failure

NCT06939985 | Recruiting

• 1 other identifier: RJH-CUREHF
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Changes in cardiac function

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

  12 months

• Major cardiovascular events (MACEs)

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

  5 years

Secondary Outcomes (17)

• HF re-hospitalization

  5 years

• Cardiovascular death

  5 years

• All-cause mortality

  5 years

• Dynamic transition among HF phenotypes

  12 months

• Changes in cardiac diastolic function

  12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, 200025, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Heart Failure; Metabolic Syndrome; Metabolic Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases

Study Officials

• Ruiyan Zhang, M.D., Ph.D.

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

• Xiaoqun Wang, M.D., Ph.D.

  Ruijin Hospital

  STUDY CHAIR

Central Study Contacts

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D., FACC, FESC

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: April 23, 2025
• Study Start: January 1, 2015
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2030
• Last Updated: April 23, 2025

Record last verified: 2025-04

Locations

CN (1)