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临床试验/NCT06338033
NCT06338033已完成不适用

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

Chongqing Medical University1 个研究点 分布在 1 个国家目标入组 298 人开始时间: 2020年9月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
298
试验地点
1
主要终点
All-cause mortality

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

All-cause mortality

时间窗: November 30, 2023

All-cause mortality

次要结局

  • Rehospitalization for heart failure(November 30, 2023)

研究者

发起方
Chongqing Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dongying Zhang

Clinical Professor

Chongqing Medical University

研究点 (1)

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