FAiling HearT in the Elderly (FATE) Study
- Conditions
- Heart FailureFrailty
- Registration Number
- NCT06343233
- Lead Sponsor
- IRCCS Multimedica
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 5000
- Patients aged > 65 years;
- Patients hospitalized for acute heart failure;
- Signature of informed consent.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Hospitalization or death at 12 months up to 12 months Analyzing the prevalence of hospitalizations and/or deaths due to cardiovascular causes at 12 months from enrollment.
- Secondary Outcome Measures
Name Time Method hospitalizations and/or death from cardiovascular causes up to 6 and18 months Prevalence and incidence of hospitalizations and/or death from cardiovascular causes at 6 and 18 months;
Hospitalization or death at 6-12-18 months up to 6-12-18 months Prevalence of hospitalizations and/or death from all causes at 6, 12, and 18 months from enrollment;
association between events and patient characteristics up to 18 months 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.
Trial Locations
- Locations (7)
IRCCS Humanitas Research Hospital
🇮🇹Rozzano, Milano, Italy
Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico
🇮🇹Milan, Italy
IRCCS Centro Cardiologico Monzino
🇮🇹Milan, MIlano, Italy
Istituti clinici scientifici Maugeri - IRCCS Montescano ( Cardiologia DPT)
🇮🇹Montescano, Italy/Pavia, Italy
Ospedale Policlinico San Martino IRCCS
🇮🇹Genova, Italy
IRCCS Auxologico
🇮🇹Milano, Italy
IRCCS MultiMedica
🇮🇹Sesto San Giovanni, Milano, Italy