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临床试验/NCT02444416
NCT02444416招募中不适用

Prospective Registry of Acute Heart Failure

Sebastian Carballo1 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2014年12月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,200
试验地点
1
主要终点
Prognostic factors (including the acute renal failure and worsening renal function) in the acute heart failure

研究概览

简要总结

Context:

Heart failure is associated with a high morbidity and mortality rate and represents a significant worldwide public health burden. In European countries, the total amount of the expenses related to heart failure represents 1 to 2% of the total health budget with 75% spent during hospitalizations, making heart failure the most expensive pathology in cardiology. Acute heart failure (AHF) has a poor prognosis despite improvements in therapy. Hospital mortality is 2 to 4% the risk of death or readmission in the six months following hospitalization is high.

Patients hospitalized for heart failure represent a very heterogeneous population in terms of etiologies, clinical presentations and/or co-morbidities. Consequently, this implies variable outcomes in terms of morbidity and mortality, probably due to their different prognostic factors. The precise spectrum of etiologies and prognostic factors of AHF in non selected populations has not been exhaustively studied and only a few predictive models concerning AHF have been validated.

Ischemic heart disease, valvulopathy, arrhythmias, infections, hypertension and lack of therapeutic compliance are often quoted as being the factors triggering heart failure. Some triggering factors (ischemic heart disease, pulmonary infections, acute renal failure) seem to be strongly associated with a poor prognosis in terms of hospital/out-patient mortality and re-hospitalization rate.

The complex relation between heart failure and acute renal failure is defined by the cardio-renal syndrome. Thirty percent of patients hospitalized for AHF will be diagnosed with an acute renal failure at admission or with worsening kidney failure during hospitalization. It seems that heart failure and cardio-renal syndrome are two distinct entities with a different prognosis. The type of acute renal failure (functional, renal or post-renal) in these patients and the prognostic value of these etiologies is still not firmly established.

A thorough determination of the etiologies and prognostic factors of AHF are necessary in order to allow the identification of high-risk patients and the improvement of heart failure management.

Objectives:

  • To create an observational registry of all patients hospitalized for a AHF
  • To determine the precise prevalence of etiologies and the prognostic factors of AHF in a non selected population. Among the prognostic factors, to establish the specific role of acute renal failure
  • To establish the optimal initial assessment of patients hospitalized for heart failure
  • To validate and compare with prospective data the results of a retrospective cohort study carried out at the University Hospital of Geneva who established the re-hospitalization and mortality outcome of patients hospitalized for heart failure.

Method:

Creation of an observational registry associated with a biobank including patients hospitalized for AHF in the Department of General Internal medicine (SMIG) and in the Departments of Specialties at the University Hospital of Geneva.

Anticipated results:

  • To identify the prevalence of the etiologies and the prognostic factors of the heart failure
  • To establish the optimal initial assessment of the patients hospitalized for a heart failure. Among the prognostic factors, to establish the specific role of acute renal failure
  • To validate and compare results of a retrospective cohort study carried out at the University Hospital of Geneva which established the re-hospitalization and mortality outcome of patients hospitalized AHF
  • To improve the management of hospitalized patients with AHF with a robust identification of the etiologies and a better identification of high-risk patients.

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
16 Years 至 100 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Usual clinical presentation of acute heart failure as defined by the European Society of Cardiology : Gradual onset or new or worsening symptoms of rapid heart failure (eg, dyspnea, edema of the lower limbs and tiredness ) and signs of heart failure (eg elevation of jugular venous pressure, crackles, moving the shock peak) requiring urgent treatment.
  • Brain natriuretic peptide or value of brain natriuretic peptide (BNP) greater than 100 ng / L.

排除标准

  • Inability or refusal to consent to participate in the study cohort.

结局指标

主要结局

Prognostic factors (including the acute renal failure and worsening renal function) in the acute heart failure

时间窗: baseline

Rehospitalization and early and late mortality

时间窗: 30 days, 90days, 1 year and 2 years

Prevalence of different clinical presentations of the acute heart failure

时间窗: baseline

Prevalence of the triggers of the acute heart failure

时间窗: baseline

次要结局

未报告次要终点

研究者

发起方
Sebastian Carballo
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sebastian Carballo

Principal Investigator

University Hospital, Geneva

研究点 (1)

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