Clinical trial NCT06343233: FAiling HearT in the Elderly (FATE) Study
Official title: Multicenter, Prospective Observational Study of Patients Aged 65 Years or Older, Hospitalized for Acute Heart Failure.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure
Frailty
Keywords: heart failure
Fraility
ELderly
primary and secondary prevention
Lead sponsor: IRCCS Multimedica
Sponsor class: OTHER
First posted: 2024-04-02
Enrollment: 5000
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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).

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Hospitalization or death at 12 months
timeFrame: up to 12 months
Secondary outcomes:
measure: Hospitalization or death at 6-12-18 months
timeFrame: up to 6-12-18 months
measure: hospitalizations and/or death from cardiovascular causes
timeFrame: up to 6 and18 months
measure: association between events and patient characteristics
timeFrame: up to 18 months
Other outcomes:
Locations:
city: Montescano
country: Italy
facility: Istituti clinici scientifici Maugeri - IRCCS Montescano ( Cardiologia DPT)
state: Italy/Pavia
city: Milan
country: Italy
facility: IRCCS Centro Cardiologico Monzino
state: MIlano
city: Rozzano
country: Italy
facility: IRCCS Humanitas Research Hospital
state: Milano
city: Sesto San Giovanni
country: Italy
facility: IRCCS MultiMedica
state: Milano
city: Genova
country: Italy
facility: Ospedale Policlinico San Martino IRCCS
city: Milano
country: Italy
facility: IRCCS Auxologico
city: Milan
country: Italy
facility: Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico
Study officials:
affiliation: MultiMedica - IRCCS MultiMedica - Cardiology
name: Gaia CAttadori, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Ezekowitz JA, O'Meara E, McDonald MA, Abrams H, Chan M, Ducharme A, Giannetti N, Grzeslo A, Hamilton PG, Heckman GA, Howlett JG, Koshman SL, Lepage S, McKelvie RS, Moe GW, Rajda M, Swiggum E, Virani SA, Zieroth S, Al-Hesayen A, Cohen-Solal A, D'Astous M, De S, Estrella-Holder E, Fremes S, Green L, Haddad H, Harkness K, Hernandez AF, Kouz S, LeBlanc MH, Masoudi FA, Ross HJ, Roussin A, Sussex B. 2017 Comprehensive Update of the Canadian Cardiovascular Society Guidelines for the Management of Heart Failure. Can J Cardiol. 2017 Nov;33(11):1342-1433. doi: 10.1016/j.cjca.2017.08.022. Epub 2017 Sep 6.
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