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

Completed

• Conditions: Heart Failure With Preserved Ejection Fraction and Visceral Fat

• Registration Number: NCT06338033
• Lead Sponsor: Chongqing Medical University

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.

Study Timeline

• Study Start: 2020-09-19
• Status Verified: 2023-04
• Primary Completion: 2023-08-28
• Study Completion: 2023-11-30
• Study First Submitted: 2024-03-23
• Study First Submitted QC: 2024-03-23
• Last Update Submitted: 2024-03-23
• Study First Posted: 2024-03-29
• Last Update Posted: 2024-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 298

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All-cause mortality	November 30, 2023	All-cause mortality

Secondary Outcome Measures

Name	Time	Method
Rehospitalization for heart failure	November 30, 2023	Rehospitalization for heart failure

Trial Locations

Locations (1)

The First Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, China