About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
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%.
Disqualifiers
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.
Trial 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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Changes in cardiac function
Changes in ejection fraction (EF) measured by echocardiography or cardiac MRI at baseline and during follow-up.
Major cardiovascular events (MACEs)
A composite endpoint of HF re-hospitalizaion and cardiovascular death during follow-up
Secondary outcomes
HF re-hospitalization
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.
Cardiovascular death
The occurrence of cardiovascular death during follow-up.
All-cause mortality
The occurrence of death during follow-up
Dynamic transition among HF phenotypes
The occurrence of transition among HF phenotypes (HFrEF, HFimpEF, HFmrEF, HFpEF) measured by echocardiography or cardiac MRI at baseline and during follow-up
Sponsors and contacts
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