An observational study in Heart Failure and Frailty, sponsored by IRCCS Multimedica. Recruiting at 7 sites in Italy. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2024-04-02.
Sponsored by IRCCS Multimedica · Observational
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.
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's planned enrollment of 5,000 is above the median of 200 across 1,679 observational studies indexed under Heart Failure.
Browse Heart Failure studies →IRCCS Multimedica is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients aged 65 years or older hospitalized for acute decompensated heart failure (ADHF). The index event must be documented, at the time of discharge, by the need for intravenous administration of specific treatments and classified based on the International Classification of Diseases (ICD-9 code 428 or codes consistent with the presence of any heart failure, for primary or secondary disease).
Exclusion Criteria:
The aim is to set up a collection of clinical and instrumental data of usual care from patients hospitalized for acute heart failure aged ≥ 65; at the time of admission and after 6-12 and 18 months from the event (admission).
Hospitalization or death at 12 months
Analyzing the prevalence of hospitalizations and/or deaths due to cardiovascular causes at 12 months from enrollment.
Time frame: up to 12 months
Hospitalization or death at 6-12-18 months
Prevalence of hospitalizations and/or death from all causes at 6, 12, and 18 months from enrollment;
Time frame: up to 6-12-18 months
hospitalizations and/or death from cardiovascular causes
Prevalence and incidence of hospitalizations and/or death from cardiovascular causes at 6 and 18 months;
Time frame: up to 6 and18 months
association between events and patient characteristics
Analysis of the association between events (hospitalization and/or death) and clinical characteristics, instrumental findings, and patient co-pathologies. Both cardiovascular events and those occurring for all causes will be evaluated, stratifying the analysis.
Time frame: up to 18 months
Plan to share: Undecided
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IRCCS Multimedica