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CompletedNCT06338033Updated Mar 29, 2024

Prognostic Study of Visceral Fat and Heart Failure With Preserved Ejection Fraction

An observational study in Heart Failure With Preserved Ejection Fraction and Visceral Fat, sponsored by Chongqing Medical University. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-29.

Sponsored by Chongqing Medical University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
298
Ages
18 Years and older
Sex
All
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Study summary

Obesity and heart failure with preserved ejection fraction (HFpEF) have multiple pathologic associations that affect the prognosis of HFpEF. Chinese people are more prone to visceral obesity, resulting in varying degrees of true obesity in individuals with the same body mass index (BMI). There are no prognostic studies of VFA/BMI in the HFpEF population.

Read the detailed description

A total of 298 patients with HFpEF who were hospitalized in the Department of Cardiovascular Medicine of the First Affiliated Hospital of Chongqing Medical University from September 2020 to August 2023 were included in this prospective cohort study.All patients were followed up on November 30, 2023.The primary endpoint of the study was all-cause mortality and secondary endpoints were rehospitalization for heart failure and composite endpoints of both.After a median follow-up of 564 days, a total of 30 (10.1%) patients died and 82 (27.5%) were rehospitalized for heart failure. Patients with HFpEF were categorized into two groups according to median VFA/BMI (VFA/BMI \<5.49; VFA/BMI ≥5.49).The aim of this study was to elucidate whether VFA/BMI has prognostic value in patients with HFpEF by Kaplan-Meier survival analysis and cox regression analysis.

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Conditions studied

  • Heart Failure With Preserved Ejection Fraction and Visceral Fat

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03

In context

Heart Failure

5,703 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 298 is above the median of 200 across 1,680 observational studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Chongqing Medical University is the lead sponsor of 75 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Heart failure with preserved ejection fraction(HFpEF)

Inclusion criteria

  • Adule aged≥18 years old;
  • Diagnosed with HFpEF.

Diagnostic criteria including:

  1. left ventricular ejection fraction ≥50%;
  2. with signs and/or symptoms of heart failure;
  3. Sinus rhythm:BNP≥35pg/mL and/or NT-proBNP≥125pg/mL;Atrial fibrillation rhythm:BNP≥105pg/mL and/or NT-proBNP≥365pg/mL;
  4. at least one additional criterion: relevant structural heart disease(LVH and/or LAE) or diastolic dysfunction.

Exclusion criteria

Exclusion Criteria:

  • Age ≤18 years;
  • malignant tumor;
  • comorbid severe hepatic and/or renal insufficiency;
  • lost to follow-up.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
298 participants (actual)
Patient registry
No

Groups and cohorts

  • VFA/BMI<5.49
  • VFA/BMI≥5.49
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What researchers measure

Primary outcomes

  1. All-cause mortality

    All-cause mortality

    Time frame: November 30, 2023

Secondary outcomes

  1. Rehospitalization for heart failure

    Rehospitalization for heart failure

    Time frame: November 30, 2023

Other outcomes

  1. Composite endpoints of all-cause mortality and rehospitalization for heart failure

    Composite endpoints of all-cause mortality and rehospitalization for heart failure

    Time frame: November 30, 2023

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Study locations

1 site
  • The First Affiliated Hospital of Chongqing Medical University
    Chongqing, China
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06338033
Lead sponsor
Chongqing Medical University
Responsible party
Dongying Zhang (Clinical Professor, Chongqing Medical University) — Principal investigator
First posted
Mar 29, 2024
Start date
Sep 19, 2020
Primary completion
Aug 28, 2023
Completion
Nov 30, 2023
Last update
Mar 29, 2024

Study contacts

Dongying Zhang, doctor
study director · First Affiliated Hospital of Chongqing Medical University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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