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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06338033

Enrollment

298

Registered

2024-03-29

Start date

2020-09-19

Completion date

2023-11-30

Last updated

2024-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure With Preserved Ejection Fraction and Visceral Fat

Brief 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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
All-cause mortality	November 30, 2023	All-cause mortality

Secondary

Measure	Time frame	Description
Rehospitalization for heart failure	November 30, 2023	Rehospitalization for heart failure

Other

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

Countries

China

Outcome results