跳至主要内容
临床试验/NCT06343233
NCT06343233
招募中
不适用

Multicenter, Prospective Observational Study of Patients Aged 65 Years or Older, Hospitalized for Acute Heart Failure.

IRCCS Multimedica7 个研究点 分布在 1 个国家目标入组 5,000 人2019年11月19日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Heart Failure
发起方
IRCCS Multimedica
入组人数
5000
试验地点
7
主要终点
Hospitalization or death at 12 months
状态
招募中
最后更新
2年前

概览

简要总结

In 2015 the Italian Ministry of Health invited the Cardiac Research Hospitals of Italy to constitute a Cardiac Network. The aim of the network is to facilitate and promote scientific and technological research in the setting of cardiovascular diseases and related risk factors. The Cardiology Network, responding to the indications of the National Health Research Program, which includes research models oriented towards prevention studies with objectives and priority areas of intervention such as "acquiring scientific knowledge necessary for implementing both secondary and tertiary prevention programs for patients and primary prevention for contacts, where indicated, or for subjects exposed to specific risk factors", aims to identify strategies and/or prognostic and predictive factors of outcomes through the construction of thoroughly studied case series and systematic collection of biological materials, as well as the definition of research models based on clinical outcomes.

The Study aims to examine the impact of clinical practice and therapies, analytically considering treatments and other important covariates that contribute in a complex manner to the therapeutic success of patients with heart failure.

详细描述

Heart failure is a clinical condition continuously growing, characterized by an unfavorable prognosis both in terms of life and health. It is increasingly common and often associated with other clinical conditions that complicate its course, worsen the prognosis, and increase costs for the National Health Service (NHS). Heart failure (HF) is characterized by high prevalence (3% of the adult population, approximately 600,000 patients already diagnosed in Italy) and incidence (0.1-0.2, 87,000 cases/year). Patients with chronic HF may experience disease exacerbations leading to frequent hospitalizations, which, however, are appropriate in only a minority of cases. Heart failure is a leading cause of death and hospitalization, especially in patients over 65 years of age. The annual incidence of heart failure doubles for every decade over 65 years, with a prevalence reaching 10% in patients over 80 years of age. Age is also one of the major determinants of prognosis in heart failure patients and is associated with a higher presence of comorbidities that contribute to worse outcomes. However, fewer data are available for patients over 65 years of age, who are often excluded from major clinical and pharmacological trials.The FATE Study considers the population presenting the most common disease pattern among hospitalized patients, particularly those with acute heart failure (AHF) and older age (\> 65 years), in which the syndrome manifests with greater aggressiveness and complexity, also due to various frequently associated medical conditions. The study aims to provide clinical information in a broad sample that includes the subpopulation of patients who are usually not adequately represented in traditional clinical studies or even excluded, namely the elderly subjects. Therefore, the development of the FATE study will provide a unique tool for healthcare management methodologies. The study design will use highly flexible data collection strategies, particularly useful in the dynamics of data collection in patients. The FATE Study considers the population presenting the most frequent disease pattern among hospitalized patients, particularly those with acute heart failure (AHF) and older age (\> 65 years), in which the syndrome manifests with greater aggressiveness and complexity, also due to various frequently associated medical conditions. The study aims to provide clinical information in a broad sample that includes the subpopulation of patients who are usually not adequately represented in traditional clinical studies or even excluded, namely the elderly subjects. Therefore, the development of the FATE study will provide a unique tool for healthcare management methodologies. The study design will use highly flexible data collection strategies, particularly useful in the dynamics of data collection in patients. With its specific characteristics, the Study aims to examine the impact of clinical practice and therapies, analytically considering treatments and other important covariates that contribute in a complex manner to the therapeutic success of patients with heart failure.

注册库
clinicaltrials.gov
开始日期
2019年11月19日
结束日期
2024年12月
最后更新
2年前
研究类型
Observational
性别
All

研究者

发起方
IRCCS Multimedica
责任方
Sponsor

入排标准

入选标准

  • Patients aged \> 65 years;
  • Patients hospitalized for acute heart failure;
  • Signature of informed consent.

排除标准

  • Patients with significant valvular pathology at T0/Baseline (index event);
  • Patients with malignant neoplasms or systemic pathology with a prognosis "quoad vitam" less than 1 year;
  • Patients with known active infectious diseases.

结局指标

主要结局

Hospitalization or death at 12 months

时间窗: up to 12 months

Analyzing the prevalence of hospitalizations and/or deaths due to cardiovascular causes at 12 months from enrollment.

次要结局

  • hospitalizations and/or death from cardiovascular causes(up to 6 and18 months)
  • Hospitalization or death at 6-12-18 months(up to 6-12-18 months)
  • association between events and patient characteristics(up to 18 months)

研究点 (7)

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