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

March 23, 2024 updated by: Dongying Zhang, Chongqing Medical University
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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

298

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Chongqing, China
        • The First Affiliated Hospital of Chongqing Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Heart failure with preserved ejection fraction(HFpEF)

Description

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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
VFA/BMI<5.49
VFA/BMI≥5.49

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: November 30, 2023
All-cause mortality
November 30, 2023

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rehospitalization for heart failure
Time Frame: November 30, 2023
Rehospitalization for heart failure
November 30, 2023

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite endpoints of all-cause mortality and rehospitalization for heart failure
Time Frame: November 30, 2023
Composite endpoints of all-cause mortality and rehospitalization for heart failure
November 30, 2023

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chongqing Medical University

Investigators

  • Study Director: Dongying Zhang, doctor, First Affiliated Hospital of Chongqing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 19, 2020

Primary Completion (Actual)

August 28, 2023

Study Completion (Actual)

November 30, 2023

Study Registration Dates

First Submitted

March 23, 2024

First Submitted That Met QC Criteria

March 23, 2024

First Posted (Actual)

March 29, 2024

Study Record Updates

Last Update Posted (Actual)

March 29, 2024

Last Update Submitted That Met QC Criteria

March 23, 2024

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-03-23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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