FAiling HearT in the Elderly (FATE) Study

Heart Failure Clinical Trial

— FATE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06343233
• Other study ID #: FATE
• Status: Recruiting
• Start date: November 19, 2019
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: IRCCS Multimedica
• Contact: Gaia Cattadori, MD
• Phone: +39 02 8687 8889
• Email: gaia.cattadori[@]multimedica.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Frailty
• Heart Failure

Intervention

Other:
• usual care
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).

Locations

Country	Name	City	State
Italy	Ospedale Policlinico San Martino IRCCS	Genova
Italy	Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico	Milan
Italy	IRCCS Centro Cardiologico Monzino	Milan	MIlano
Italy	IRCCS Auxologico	Milano
Italy	Istituti clinici scientifici Maugeri - IRCCS Montescano ( Cardiologia DPT)	Montescano	Italy/Pavia
Italy	IRCCS Humanitas Research Hospital	Rozzano	Milano
Italy	IRCCS MultiMedica	Sesto San Giovanni	Milano

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Multimedica

Country where clinical trial is conducted

Italy, 

References & Publications (5)

Brignole M, Auricchio A, Baron-Esquivias G, Bordachar P, Boriani G, Breithardt OA, Cleland J, Deharo JC, Delgado V, Elliott PM, Gorenek B, Israel CW, Leclercq C, Linde C, Mont L, Padeletti L, Sutton R, Vardas PE; ESC Committee for Practice Guidelines (CPG — View 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, — View Citation

Krum H, Jelinek MV, Stewart S, Sindone A, Atherton JJ; National Heart Foundation of Australia; Cardiac Society of Australia and New Zealand. 2011 update to National Heart Foundation of Australia and Cardiac Society of Australia and New Zealand Guidelines — View Citation

Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer — View Citation

Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Colvin MM, Drazner MH, Filippatos GS, Fonarow GC, Givertz MM, Hollenberg SM, Lindenfeld J, Masoudi FA, McBride PE, Peterson PN, Stevenson LW, Westlake C. 2017 ACC/AHA/HFSA Focused Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Failure Society of America. Circulation. 2017 Aug 8;136(6):e137-e161. doi: 10.1161/CIR.0000000000000509. Epub 2017 Apr 28. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospitalization or death at 12 months	Analyzing the prevalence of hospitalizations and/or deaths due to cardiovascular causes at 12 months from enrollment.	up to 12 months
Secondary	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;	up to 6-12-18 months
Secondary	hospitalizations and/or death from cardiovascular causes	Prevalence and incidence of hospitalizations and/or death from cardiovascular causes at 6 and 18 months;	up to 6 and18 months
Secondary	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.	up to 18 months