NCT05068934

Brief Summary

Heart failure with preserved ejection fraction (HFpEF) refers to a group of symptoms and signs of heart failure, normal or near-normal left ventricular systolic function (EF\>50%), and ventricular muscle diastolic dysfunction and A clinical syndrome characterized by decreased compliance and increased stiffness. The pathogenesis of HFpEF is related to impaired lipid metabolism and inflammation. Epicardial adipose tissue (Epicardial Adipose tissue, EAT) is a kind of visceral adipose tissue. Related studies have shown that extracardiac Membrane fat is related to inflammation markers, cardiometabolic risk and cardiovascular disease.However, there is still no research investigating the the relationship between epicardial fat thickness and Cardiac Function in HFpEF patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,083

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 12, 2020

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 6, 2021

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2025

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2025

Completed
Last Updated

January 6, 2026

Status Verified

December 1, 2025

Enrollment Period

5.2 years

First QC Date

September 26, 2021

Last Update Submit

December 31, 2025

Conditions

Keywords

Epicardial Adipose tissueCardiac Function

Outcome Measures

Primary Outcomes (3)

  • Epicardial Fat Tissue

    Epicardial Fat Tissue by cardiac color Doppler ultrasound

    On admission

  • Cardiac Function

    Left ventricular diastolic function and right ventricular systolic function by cardiac color Doppler ultrasound

    On admission

  • Composite Endpoint of Worsening Heart Failure Event and Cardiovascular Death

    Composite Endpoint of Worsening Heart Failure Event and Cardiovascular Death

    From date of discharge until the date of first worsening HF event or date of death, whichever came first, assessed up to 5 years

Secondary Outcomes (3)

  • Worsening HF Event

    From date of discharge until the date of first worsening HF event or date of death, whichever came first, assessed up to 5 years

  • CV Death

    From date of discharge until the date of death, whichever came first, assessed up to 10 years

  • All-cause Death

    From date of discharge until the date of death, whichever came first, assessed up to 10 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Heart failure patients with preserved ejection fraction (HFpEF)

You may qualify if:

  • Adult aged \>=18years old;
  • Diagnosed with HFpEF.
  • Diagnostic criteria including:
  • left ventricular ejection fraction ≥50%;
  • with the symptoms and/or signs of heart failure;
  • BNP≥35 pg/mL and/or NTproBNP≥125 pg/mL;
  • at least one additional criterion: relevant structural heart disease(LVH and/or LAE) or diastolic dysfunction

You may not qualify if:

  • LVEF less than 45% at any time;
  • Severe liver failure;
  • Primary pulmonary hypertension;
  • Age \<18 years old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, China

Location

Study Officials

  • Dongying Zhang, doctor

    First Affiliated Hospital of Chongqing Medical University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dongying Zhang

Study Record Dates

First Submitted

September 26, 2021

First Posted

October 6, 2021

Study Start

October 12, 2020

Primary Completion

December 10, 2025

Study Completion

December 15, 2025

Last Updated

January 6, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations