Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-02-04 @ 6:25 AM
Study NCT ID:
NCT06343233
Status:
RECRUITING
Last Update Posted:
2024-04-02
First Post:
2024-03-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
FAiling HearT in the Elderly (FATE) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D000073496', 'term': 'Frailty'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-11-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-29', 'studyFirstSubmitDate': '2024-03-17', 'studyFirstSubmitQcDate': '2024-03-29', 'lastUpdatePostDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hospitalization or death at 12 months', 'timeFrame': 'up to 12 months', 'description': 'Analyzing the prevalence of hospitalizations and/or deaths due to cardiovascular causes at 12 months from enrollment.'}], 'secondaryOutcomes': [{'measure': 'Hospitalization or death at 6-12-18 months', 'timeFrame': 'up to 6-12-18 months', 'description': 'Prevalence of hospitalizations and/or death from all causes at 6, 12, and 18 months from enrollment;'}, {'measure': 'hospitalizations and/or death from cardiovascular causes', 'timeFrame': 'up to 6 and18 months', 'description': 'Prevalence and incidence of hospitalizations and/or death from cardiovascular causes at 6 and 18 months;'}, {'measure': 'association between events and patient characteristics', 'timeFrame': 'up to 18 months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['heart failure', 'Fraility', 'ELderly', 'primary and secondary prevention'], 'conditions': ['Heart Failure', 'Frailty']}, 'referencesModule': {'references': [{'pmid': '28455343', 'type': 'BACKGROUND', '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.'}, {'pmid': '27206819', 'type': 'RESULT', '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 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': '23801822', 'type': 'RESULT', 'citation': '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': '29111106', 'type': 'RESULT', '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."}, {'pmid': '21495941', 'type': 'RESULT', '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 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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.', 'detailedDescription': '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.\n\nHeart 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged \\> 65 years;\n* Patients hospitalized for acute heart failure;\n* Signature of informed consent.\n\nExclusion Criteria:\n\n* Patients with significant valvular pathology at T0/Baseline (index event);\n* Patients with malignant neoplasms or systemic pathology with a prognosis "quoad vitam" less than 1 year;\n* Patients with known active infectious diseases.'}, 'identificationModule': {'nctId': 'NCT06343233', 'acronym': 'FATE', 'briefTitle': 'FAiling HearT in the Elderly (FATE) Study', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Multimedica'}, 'officialTitle': 'Multicenter, Prospective Observational Study of Patients Aged 65 Years or Older, Hospitalized for Acute Heart Failure.', 'orgStudyIdInfo': {'id': 'FATE'}}, 'armsInterventionsModule': {'interventions': [{'name': 'usual care', 'type': 'OTHER', 'description': '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).'}]}, 'contactsLocationsModule': {'locations': [{'zip': '27040', 'city': 'Montescano', 'state': 'Italy/Pavia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Maria Teresa La Rovere, MD', 'role': 'CONTACT', 'email': 'mariateresa.larovere@icsmaugeri.it', 'phone': '+39 0385 247290'}], 'facility': 'Istituti clinici scientifici Maugeri - IRCCS Montescano ( Cardiologia DPT)', 'geoPoint': {'lat': 45.03196, 'lon': 9.28366}}, {'zip': '20138', 'city': 'Milan', 'state': 'MIlano', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'PierGiuseppe Agostoni, MD', 'role': 'CONTACT', 'email': 'piergiuseppe.agostoni@unimi.it', 'phone': '+39 02 58002772'}], 'facility': 'IRCCS Centro Cardiologico Monzino', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '20089', 'city': 'Rozzano', 'state': 'Milano', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Cristina Panico, MD', 'role': 'CONTACT', 'email': 'cristina.panico@humanitas.it', 'phone': '+39 0282241'}], 'facility': 'IRCCS Humanitas Research Hospital', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}, {'zip': '20099', 'city': 'Sesto San Giovanni', 'state': 'Milano', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Gaia Cattadori, MD', 'role': 'CONTACT', 'email': 'gaia.cattadori@multimedica.it', 'phone': '+39 02 8687 8889'}], 'facility': 'IRCCS MultiMedica', 'geoPoint': {'lat': 45.53329, 'lon': 9.22585}}, {'zip': '16132', 'city': 'Genova', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Pietro Ameri, MD', 'role': 'CONTACT', 'email': 'pietroameri@unige.it', 'phone': '+39 0103538928'}], 'facility': 'Ospedale Policlinico San Martino IRCCS', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'zip': '20100', 'city': 'Milan', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Marco Vicenzi, MD', 'role': 'CONTACT', 'email': 'marco.vicenzi@unimi.it', 'phone': '+39 02 503 20512'}], 'facility': "Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico", 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '20149', 'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Gianluca Caldara, MD', 'role': 'CONTACT', 'email': 'g.caldara@auxologico.it', 'phone': '+39 02 61911 251'}], 'facility': 'IRCCS Auxologico', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}], 'centralContacts': [{'name': 'Gaia Cattadori, MD', 'role': 'CONTACT', 'email': 'gaia.cattadori@multimedica.it', 'phone': '+39 02 8687 8889'}], 'overallOfficials': [{'name': 'Gaia CAttadori, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MultiMedica - IRCCS MultiMedica - Cardiology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Multimedica', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}