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OpenTrials
Completed

NCT Number: NCT06338033

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Diagnostic criteria including:

  • left ventricular ejection fraction ≥50%;
  • with signs and/or symptoms of heart failure;
  • Sinus rhythm:BNP≥35pg/mL and/or NT-proBNP≥125pg/mL;Atrial fibrillation rhythm:BNP≥105pg/mL and/or NT-proBNP≥365pg/mL;
  • 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.

Treatment and study plan

Primary outcomes

  1. All-cause mortality

    Time frame: November 30, 2023

    All-cause mortality

Secondary outcomes

  1. Rehospitalization for heart failure

    Time frame: November 30, 2023

    Rehospitalization for heart failure

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Chongqing Medical University

Other

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Mar 29, 2024
Registry last updated
Mar 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.