FAiling HearT in the Elderly (FATE) Study (FATE)

March 29, 2024 updated by: IRCCS Multimedica

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Genova, Italy, 16132
        • Recruiting
        • Ospedale Policlinico San Martino IRCCS
        • Contact:
      • Milan, Italy, 20100
        • Not yet recruiting
        • Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico
        • Contact:
      • Milano, Italy, 20149
        • Recruiting
        • IRCCS Auxologico
        • Contact:
    • Italy/Pavia
      • Montescano, Italy/Pavia, Italy, 27040
        • Recruiting
        • Istituti clinici scientifici Maugeri - IRCCS Montescano ( Cardiologia DPT)
        • Contact:
    • MIlano
      • Milan, MIlano, Italy, 20138
    • Milano
      • Rozzano, Milano, Italy, 20089
      • Sesto San Giovanni, Milano, Italy, 20099

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

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).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospitalization or death at 12 months
Time Frame: up to 12 months
Analyzing the prevalence of hospitalizations and/or deaths due to cardiovascular causes at 12 months from enrollment.
up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospitalization or death at 6-12-18 months
Time Frame: up to 6-12-18 months
Prevalence of hospitalizations and/or death from all causes at 6, 12, and 18 months from enrollment;
up to 6-12-18 months
hospitalizations and/or death from cardiovascular causes
Time Frame: up to 6 and18 months
Prevalence and incidence of hospitalizations and/or death from cardiovascular causes at 6 and 18 months;
up to 6 and18 months
association between events and patient characteristics
Time Frame: 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.
up to 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Multimedica

Investigators

  • Principal Investigator: Gaia CAttadori, MD, MultiMedica - IRCCS MultiMedica - Cardiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 19, 2019

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

March 17, 2024

First Submitted That Met QC Criteria

March 29, 2024

First Posted (Actual)

April 2, 2024

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

March 29, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FATE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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