Cardiometabolic evalUation REgistry of Heart Failure
Recruiting · NCT06939985 · Observational (researchers observe without assigning treatment) · Lead sponsor: Ruijin Hospital
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
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.
Where it is running
1 location listed.
- Ruijin Hospital, Shanghai Jiaotong University School of Medicine - Shanghai, China