Cardiometabolic evalUation REgistry of Heart Failure

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRuijin Hospital

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Changes in cardiac function

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

Time frame
12 months
2

Major cardiovascular events (MACEs)

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

Time frame
5 years

Secondary outcomes

1

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.

Time frame
5 years
2

Cardiovascular death

The occurrence of cardiovascular death during follow-up.

Time frame
5 years
3

All-cause mortality

The occurrence of death during follow-up

Time frame
5 years
4

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

Time frame
12 months

Other outcomes

Sponsors and contacts

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