FAiling HearT in the Elderly (FATE) Study

NCT06343233 | Recruiting

• 1 other identifier: FATE
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 7

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.

Conditions

Heart Failure; Frailty

Keywords

heart failure; Fraility; ELderly; primary and secondary prevention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Hospitalization or death at 6-12-18 months

  up to 6-12-18 months

• hospitalizations and/or death from cardiovascular causes

  up to 6 and18 months

• association between events and patient characteristics

  up to 18 months

Interventions

usual care OTHER

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).

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS Multimedica: lead

Study Sites (7)

Istituti clinici scientifici Maugeri - IRCCS Montescano ( Cardiologia DPT)

Montescano, Italy/Pavia, 27040, Italy

RECRUITING

IRCCS Centro Cardiologico Monzino

Milan, MIlano, 20138, Italy

RECRUITING

IRCCS Humanitas Research Hospital

Rozzano, Milano, 20089, Italy

RECRUITING

IRCCS MultiMedica

Sesto San Giovanni, Milano, 20099, Italy

RECRUITING

Ospedale Policlinico San Martino IRCCS

Genova, 16132, Italy

RECRUITING

Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico

Milan, 20100, Italy

NOT YET RECRUITING

IRCCS Auxologico

Milan, 20149, Italy

RECRUITING

Related Publications (5)

• 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.

  PMID: 28455343 BACKGROUND

• 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 P; ESC Scientific Document Group. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016 Jul 14;37(27):2129-2200. doi: 10.1093/eurheartj/ehw128. Epub 2016 May 20. No abstract available.

  PMID: 27206819 RESULT

• 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); Zamorano JL, Achenbach S, Baumgartner H, Bax JJ, Bueno H, Dean V, Deaton C, Erol C, Fagard R, Ferrari R, Hasdai D, Hoes AW, Kirchhof P, Knuuti J, Kolh P, Lancellotti P, Linhart A, Nihoyannopoulos P, Piepoli MF, Ponikowski P, Sirnes PA, Tamargo JL, Tendera M, Torbicki A, Wijns W, Windecker S; Document Reviewers; Kirchhof P, Blomstrom-Lundqvist C, Badano LP, Aliyev F, Bansch D, Baumgartner H, Bsata W, Buser P, Charron P, Daubert JC, Dobreanu D, Faerestrand S, Hasdai D, Hoes AW, Le Heuzey JY, Mavrakis H, McDonagh T, Merino JL, Nawar MM, Nielsen JC, Pieske B, Poposka L, Ruschitzka F, Tendera M, Van Gelder IC, Wilson CM. 2013 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy: the Task Force on cardiac pacing and resynchronization therapy of the European Society of Cardiology (ESC). Developed in collaboration with the European Heart Rhythm Association (EHRA). Eur Heart J. 2013 Aug;34(29):2281-329. doi: 10.1093/eurheartj/eht150. Epub 2013 Jun 24. No abstract available.

  PMID: 23801822 RESULT

• 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.

  PMID: 29111106 RESULT

• 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 for the prevention, detection and management of chronic heart failure in Australia, 2006. Med J Aust. 2011 Apr 18;194(8):405-9. doi: 10.5694/j.1326-5377.2011.tb03031.x.

  PMID: 21495941 RESULT

MeSH Terms

Conditions

Heart Failure; Frailty

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gaia CAttadori, MD

  MultiMedica - IRCCS MultiMedica - Cardiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gaia Cattadori, MD

CONTACT

+39 02 8687 8889; gaia.cattadori@multimedica.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2024
• First Posted: April 2, 2024
• Study Start: November 19, 2019
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 2, 2024

Record last verified: 2024-03

Locations

IT (7)