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临床试验/NCT07510035
NCT07510035已完成不适用

A Cross-Sectional Observational Study:Prevalence and Associated Factors of Frailty in Hospitalized Elderly Patients With Heart Failure

Zhejiang Hospital1 个研究点 分布在 1 个国家目标入组 298 人开始时间: 2023年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
298
试验地点
1
主要终点
Clinical Frail Scale (CFS) score

研究概览

简要总结

The goal of this observational study is to investigate the prevalence and associated factors of frailty in hospitalized elderly patients with heart failure. The main questions it aims to answer are:(1) To clarify differences in demographic characteristics and test results (including CGA, BNP, and echocardiography) among different frail populations (2) What demographic, clinical, and geriatric assessment factors are independently associated with frailty in elderly patients with heart failure?

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

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

入选标准

  • Age≥60 years
  • Patients with complete data(Patients who have completed the comprehensive geriatric assessment,BNP testing, electrocardiogram and echocardiography).
  • Patients meeting the diagnostic criteria for heart failure (as defined in the "Chinese Guidelines for the Diagnosis and Treatment of Heart Failure 2024")

排除标准

  • Patients with incomplete data
  • Patients with severe physical or cognitive impairments that prevent them from completing the assessment.
  • Acute Infections or cerebrovascular diseases
  • Terminal illnesses

研究组 & 干预措施

Non-frail Group

Participants with a Clinical Frailty Scale (CFS) score ranging from 0 to 4.

Moderate Frailty Group

Participants with a Clinical Frailty Scale (CFS) score ranging from 5 to 6.

Severe Frailty Group

Participants with a Clinical Frailty Scale (CFS) score of 7

结局指标

主要结局

Clinical Frail Scale (CFS) score

时间窗: Baseline

The CFS is assessed through clinical judgment based on a patient's functional status, mobility, activity tolerance, comorbidities, and cognitive function in the preceding two weeks. The scale classifies patients into nine levels based on their degree of frailty: 1 - Very Fit, 2 - Well, 3 - Managing Well, 4 - Vulnerable, 5 - Mildly Frail, 6 - Moderately Frail, 7 - Severely Frail, 8 - Very Severely Frail, and 9 - Terminally Ill. The higher the CFS score, the greater the degree of frailty. Excluding those with scores of 8-9, patients with scores of 0-4 are classified into the non-frail group, while those with scores of 5 or higher are classified into the frail group. Frailty Severity Grading Criteria: Clinical Frailty Scale (CFS) score: non-frail (CFS 0-4), moderate frailty (CFS 5-6), and severe frailty (CFS 7).

brain natriuretic peptide (BNP)

时间窗: Baseline

Assessed using a blood sample analyzed by an immunoassay. This biomarker reflects ventricular wall stress and is widely used for diagnosing and monitoring heart failure. BNP levels are reported in ng/L. According to clinical guidelines, a BNP \<100 ng/L is considered normal in untreated patients; levels \>400 ng/L are strongly suggestive of heart failure, while values between 100 and 400 ng/L are considered intermediate and should be interpreted in the clinical context. Higher BNP levels indicate greater cardiac stress and correlate with worse outcomes.

left ventricular ejection fraction (LVEF) value

时间窗: Baseline

Assessed using echocardiography (transthoracic echocardiography is the standard method), or alternatively by cardiac magnetic resonance imaging or nuclear imaging. This imaging parameter quantifies the percentage of blood ejected from the left ventricle during systole and is the primary measure of systolic function. LVEF is reported as a percentage (%). According to clinical guidelines, a normal LVEF is ≥50%; a mildly reduced LVEF is 40-49%; a moderately reduced LVEF is 30-39%; and a severely reduced LVEF is \<30%. Lower LVEF values indicate worse systolic dysfunction and are associated with increased risk of heart failure and adverse outcomes.

次要结局

  • body mass index (BMI)(Baseline)
  • activities of daily living (ADL) score(Baseline)
  • instrumental activities of daily living (IADL) score(Baseline)
  • short physical performance battery (SPPB) score(Baseline)
  • performance-oriented mobility assessment (POMA) score(Baseline)
  • mini nutritional assessment-short form(MNA-SF) score(Baseline)
  • grip strength(Baseline)
  • skeletal muscle mass index (SMI)(Baseline)
  • dominant calf circumference(Baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiufang Hong

Associate Chief Physician

Zhejiang Hospital

研究点 (1)

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