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临床试验/NCT04753814
NCT04753814已完成不适用

Predictors of an Unfavorable Outcome in Patients With Heart Failure With Reduced, Midrange and Preserved Left Ventricular Ejection Fraction

Polish Mother Memorial Hospital Research Institute2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年2月1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
100
试验地点
2
主要终点
Prognosis in heart failure

研究概览

简要总结

The subject of the study is the factors of unfavorable prognosis in heart failure. We would like to identify independent variables associated with a bad prognosis of patients hospitalized for heart failure with a reduced vs. a mid range and preserved left ventricular ejection fraction based on specific predictive models. It is planned to create multifactorial models that can be used to predict prognosis for individual patients.

详细描述

About 100 adult patients hospitalized for HF in the Department of Cardiology will be included in the study, including: the study group with HFrEF, HFmrEF and HFpEF. Selected prognostic factors will be analyzed, among others: demographic data of the patient, physical examination, symptoms, etiology and history of HF, co-morbidities, results of selected laboratory tests, selected electrocardiographic and echocardiographic data, patient's cooperation with the doctor, treatment applied, parameters in the spiroergometric study and distance in 6MWT and subjective assessment of quality of life according to the KCCQ questionnaire. One year after inclusion in the study, a telephone interview will be conducted with patients. These will be questions about death, cardiovascular adverse events, hospitalization for heart failure and re-evaluation of the quality of life according to the KCCQ questionnaire.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

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

  • Age equal to or older than 18 years
  • HF (ischemic and non-ischemic) diagnosed according to the 2016 European Society of Cardiology (ESC) guidelines on HF [1], with HF class I, II or III according to the NYHA classification
  • current HF hospitalization
  • left ventricular ejection fraction (LVEF) documented in echocardiography during the current hospitalization

排除标准

  • advanced liver failure (class B and C according to Child-Pugh score
  • advanced chronic kidney disease (stages G4 and G5 according to the 2012 Kidney Disease: Improving Global Outcomes (KDIGO) classification
  • cerebrovascular accident (transient ischemic attack (TIA) / stroke / intracerebral haemorrhage) within 3 months prior to the hospitalization
  • current pregnancy or lactation
  • alcohol and drug abuse
  • active autoimmune disease
  • surgery or a serious injury within 1 months prior to the hospitalization
  • other important medical condition that could have shortened the survival time during the study
  • impaired cognitive status that compromises the understanding of the steps and completion of the study

结局指标

主要结局

Prognosis in heart failure

时间窗: One year after inclusion in the study

A telephone interview will be conducted with patients. These will be questions about death, cardiovascular adverse events, hospitalization for heart failure and re-evaluation of the quality of life according to the KCCQ questionnaire.

次要结局

未报告次要终点

研究者

发起方
Polish Mother Memorial Hospital Research Institute
申办方类型
Other
责任方
Sponsor

研究点 (2)

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