Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2025-12-25 @ 10:08 PM
Study NCT ID:
NCT05992558
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-03-17
First Post:
2023-08-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Longitudinal Multimarker Risk Models for Very Elderly Patients With Heart Failure and Preserved Ejection Fraction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Serum, EDTA plasma, lithium heparin plasma, and buffy coat.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 184}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-14', 'studyFirstSubmitDate': '2023-08-08', 'studyFirstSubmitQcDate': '2023-08-08', 'lastUpdatePostDateStruct': {'date': '2025-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite of 1-year all-cause mortality and/or HF-hospitalization', 'timeFrame': '12 months', 'description': 'Combined outcome of all-cause mortality and/or readmission for acute heart failure during a 12-month follow-up period after index hospitalization'}], 'secondaryOutcomes': [{'measure': '1-year HF-hospitalization', 'timeFrame': '12 months', 'description': 'Readmission for acute heart failure during a 12-month follow-up period after index hospitalization'}, {'measure': '3-month HF-hospitalization', 'timeFrame': '3 months', 'description': 'Readmission for acute heart failure during a 3-month follow-up period after index hospitalization'}, {'measure': '1-month HF-hospitalization', 'timeFrame': '1 month', 'description': 'Readmission for acute heart failure during a 1-month follow-up period after index hospitalization'}, {'measure': '1-year all-cause hospitalization', 'timeFrame': '12 months', 'description': 'All-cause readmission during a 12-month follow-up period after index hospitalization'}, {'measure': '3-month all-cause hospitalization', 'timeFrame': '3 months', 'description': 'All-cause readmission during a 3-month follow-up period after index hospitalization'}, {'measure': '1-month all-cause hospitalization', 'timeFrame': '1 month', 'description': 'All-cause readmission during a 1-month follow-up period after index hospitalization'}, {'measure': '1-year all-cause mortality', 'timeFrame': '12 months', 'description': 'All-cause mortality during a 12-month follow-up period after index hospitalization'}, {'measure': '1-year cardiovascular mortality', 'timeFrame': '12 months', 'description': 'Cardiovascular mortality during a 12-month follow-up period after index hospitalization'}, {'measure': '1-year urgent HF visits', 'timeFrame': '12 months', 'description': 'Urgent or unscheduled visit with new or worsening symptoms of acute heart failure requiring initiation of intravenous diuretic or vasoactive agent or mechanical or surgical intervention, with no hospital admission, during a 12-month follow-up period after index hospitalization'}, {'measure': '3-month urgent HF visits', 'timeFrame': '3 months', 'description': 'Urgent or unscheduled visit with new or worsening symptoms of acute heart failure requiring initiation of intravenous diuretic or vasoactive agent or mechanical or surgical intervention, with no hospital admission, during a 3-month follow-up period after index hospitalization'}, {'measure': '1-month urgent HF visits', 'timeFrame': '1 month', 'description': 'Urgent or unscheduled visit with new or worsening symptoms of acute heart failure requiring initiation of intravenous diuretic or vasoactive agent or mechanical or surgical intervention, with no hospital admission, during a 1-month follow-up period after index hospitalization'}, {'measure': '1-year worsening in NYHA class', 'timeFrame': '12 months', 'description': 'Worsening of New York Heart Association (NYHA) Functional Classification (Class I to IV) at 12 months from the index hospitalization.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Heart Failure', 'Preserved Ejection Fraction', 'Elderly', 'Prognostic model', 'Risk', 'Hospitalization'], 'conditions': ['Heart Failure With Preserved Ejection Fraction']}, 'referencesModule': {'references': [{'pmid': '34447992', 'type': 'BACKGROUND', 'citation': 'McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021 Sep 21;42(36):3599-3726. doi: 10.1093/eurheartj/ehab368. No abstract available.'}, {'pmid': '35379504', 'type': 'BACKGROUND', 'citation': 'Heidenreich PA, Bozkurt B, Aguilar D, Allen LA, Byun JJ, Colvin MM, Deswal A, Drazner MH, Dunlay SM, Evers LR, Fang JC, Fedson SE, Fonarow GC, Hayek SS, Hernandez AF, Khazanie P, Kittleson MM, Lee CS, Link MS, Milano CA, Nnacheta LC, Sandhu AT, Stevenson LW, Vardeny O, Vest AR, Yancy CW. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: Executive Summary: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2022 May 3;79(17):1757-1780. doi: 10.1016/j.jacc.2021.12.011. Epub 2022 Apr 1.'}, {'pmid': '31023695', 'type': 'BACKGROUND', 'citation': "Taylor CJ, Moore J, O'Flynn N. Diagnosis and management of chronic heart failure: NICE guideline update 2018. Br J Gen Pract. 2019 May;69(682):265-266. doi: 10.3399/bjgp19X702665. No abstract available."}, {'pmid': '33380382', 'type': 'BACKGROUND', 'citation': 'Sicras-Mainar A, Sicras-Navarro A, Palacios B, Varela L, Delgado JF. Epidemiology and treatment of heart failure in Spain: the HF-PATHWAYS study. Rev Esp Cardiol (Engl Ed). 2022 Jan;75(1):31-38. doi: 10.1016/j.rec.2020.09.033. Epub 2020 Dec 27. English, Spanish.'}, {'pmid': '32649062', 'type': 'BACKGROUND', 'citation': 'Kuster N, Huet F, Dupuy AM, Akodad M, Battistella P, Agullo A, Leclercq F, Kalmanovich E, Meilhac A, Aguilhon S, Cristol JP, Roubille F. Multimarker approach including CRP, sST2 and GDF-15 for prognostic stratification in stable heart failure. ESC Heart Fail. 2020 Oct;7(5):2230-2239. doi: 10.1002/ehf2.12680. Epub 2020 Jul 10.'}, {'pmid': '32171764', 'type': 'BACKGROUND', 'citation': 'Nunez J, Bayes-Genis A, Revuelta-Lopez E, Ter Maaten JM, Minana G, Barallat J, Cserkoova A, Bodi V, Fernandez-Cisnal A, Nunez E, Sanchis J, Lang C, Ng LL, Metra M, Voors AA. Clinical Role of CA125 in Worsening Heart Failure: A BIOSTAT-CHF Study Subanalysis. JACC Heart Fail. 2020 May;8(5):386-397. doi: 10.1016/j.jchf.2019.12.005. Epub 2020 Mar 11.'}, {'pmid': '29743019', 'type': 'BACKGROUND', 'citation': 'Pacho C, Domingo M, Nunez R, Lupon J, Nunez J, Barallat J, Moliner P, de Antonio M, Santesmases J, Cediel G, Roura S, Pastor MC, Tor J, Bayes-Genis A. Predictive biomarkers for death and rehospitalization in comorbid frail elderly heart failure patients. BMC Geriatr. 2018 May 9;18(1):109. doi: 10.1186/s12877-018-0807-2.'}, {'pmid': '16534009', 'type': 'BACKGROUND', 'citation': 'Levy WC, Mozaffarian D, Linker DT, Sutradhar SC, Anker SD, Cropp AB, Anand I, Maggioni A, Burton P, Sullivan MD, Pitt B, Poole-Wilson PA, Mann DL, Packer M. The Seattle Heart Failure Model: prediction of survival in heart failure. Circulation. 2006 Mar 21;113(11):1424-33. doi: 10.1161/CIRCULATIONAHA.105.584102. Epub 2006 Mar 13.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to develop longitudinal multimarker risk models for decision support during the clinical follow-up of very elderly patients with heart failure and preserved ejection fraction (HFpEF).\n\nThe main questions it aims to answer are:\n\n* Can advanced risk prediction models accurately estimate the prognosis of very elderly patients with HFpEF over a 1-year follow-up after a hospitalization for acute heart failure?\n* Do novel biomarkers, in addition to routine clinical variables and elderly-specific predictors, contribute to improved risk prediction for these patients?\n\nTo this end, very elderly patients (aged 80 or older) who have HFpEF and were admitted for acute heart failure will be included. Clinical and biological data will be collected during their hospitalization and also during follow-up visits 30 and 90 days after discharge.\n\nThere is no comparison group in this observational study.', 'detailedDescription': 'Background: Very elderly patients with heart failure and preserved ejection fraction (HFpEF) are under-represented in risk prediction models, and the role of prognostic biomarkers in this population is unclear due to the presence of cumulative comorbidity burden. Risk prediction is a useful tool to support decision making across the clinical follow-up of very elderly HFpEF patients.\n\nAim: To develop longitudinal prognostic models based on readily available clinical and biological variables, novel biomarkers and elderly-specific predictors to estimate prognosis over 1-year follow-up after a HF hospitalization in very elderly patients with HFpEF.\n\nDesign: Observational, single-centre, prospective cohort study of very elderly patients (≥80 years old) with HFpEF consecutively admitted for acute HF.\n\nMain outcome: Composite of 1-year all-cause mortality and/or HF-hospitalization. Sample size: 184 patients.\n\nFollow-up time: 1 year. Predictors: Routine clinical variables (sociodemographic, medical history, physical examination, vital signs, laboratory tests, imaging, concomitant medication, quality of life and elderly-specific factors) and novel biomarkers will be longitudinally collected during index hospitalization, 30-day and 90-day post-discharge visits.\n\nStatistical analysis: Kaplan-meier survival analysis. Logistic and Cox proportional-hazards regression models, time-to-event models for repeated events, linear-mixed effects, joint models, LASSO and machine learning techniques will be used for model development.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '80 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Very elderly patients (≥80 years old) with HFpEF consecutively admitted for acute HF at Hospital Universitario Ramón y Cajal and followed up at Unit of Heart Failure (UICA) of the Internal Medicine Dept.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. age ≥80 years;\n2. diagnosis of HFpEF, requiring the 4 following conditions: b1) typical symptoms and/or signs of HF; b2) left ventricular ejection fraction (LVEF) ≥50%; b3) elevated levels of natriuretic peptides (NTproBNP ≥300 pg/mL or BNP ≥100 pg/mL in sinus rhythm; NT-proBNP ≥900 pg/mL or BNP ≥300 pg/mL in atrial fibrillation); and b4) at least one additional criterion: b4.1) relevant structural heart disease (left ventricular hypertrophy and/or left atrial enlargement), or 4.2) diastolic dysfunction;\n3. hospitalization with a primary diagnosis of acute HF; and\n4. giving informed consent.\n\nExclusion Criteria:\n\n1. any clinical condition, such as HF secondary to congenital heart disease and severe valve disease, severe renal (requiring dialysis) and liver disease, active malignant diseases, autoimmune diseases, other diseases resulting in \\<1-year life expectancy or any other condition that, according to investigators' criteria, could significantly interfere with the study objectives;\n2. any clinical or social condition that prevents clinical follow-up."}, 'identificationModule': {'nctId': 'NCT05992558', 'briefTitle': 'Longitudinal Multimarker Risk Models for Very Elderly Patients With Heart Failure and Preserved Ejection Fraction', 'organization': {'class': 'OTHER', 'fullName': 'Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal'}, 'officialTitle': 'Development of Longitudinal Multimarker Risk Models for Decision Support Across the Clinical Follow-up of Very Elderly Patients With Heart Failure and Preserved Ejection Fraction', 'orgStudyIdInfo': {'id': 'PI21/00541'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Very elderly HFpEF', 'description': 'Prospective cohort of very elderly patients (≥80 years old) with heart failure with preserved ejection fraction (HFpEF) consecutively admitted for acute HF'}]}, 'contactsLocationsModule': {'locations': [{'zip': '28034', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Ramón y Cajal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Luis Manzano Espinosa, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario Ramón y Cajal'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'From 1 year after the end of the project and for at least 5 years.', 'ipdSharing': 'YES', 'description': 'After the end of the project, the generated dataset and the metadata file will be deposited in an open data repository, complying with open science criteria - FAIR.\n\nMoreover, study documentation, including study protocol, statistical analysis and informed consent form will be shared openly.', 'accessCriteria': 'IPD will be available to stakeholders, authorities, ethics committees and other parties legitimately interested in verifying their proper treatment and management.\n\nIPD may be used to ensure the scientific quality of the project results. That is to say, to carry out reproducibility of the results, if necessary at the request of scientific publication entities, among others, with prior authorization from the Research Ethics Committee, they may be reused for new research projects, provided that the consent collected allows it and/or in accordance with the applicable laws on data protection.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal', 'class': 'OTHER'}, 'collaborators': [{'name': 'Instituto de Salud Carlos III', 'class': 'OTHER_GOV'}, {'name': 'European Union', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}