Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2026-03-04 @ 9:36 PM
Study NCT ID:
NCT05922202
Status:
RECRUITING
Last Update Posted:
2025-08-05
First Post:
2023-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Frailty on Cardiovascular Events and Mortality in Patients With COPD.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-02', 'studyFirstSubmitDate': '2023-06-19', 'studyFirstSubmitQcDate': '2023-06-19', 'lastUpdatePostDateStruct': {'date': '2025-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of cardiovascular events in COPD patients living with frailty vs non-frail COPD. patients.', 'timeFrame': '12 and 24 months', 'description': 'Number of cardiovascular events (including hospital admissions for cardiovascular events) at 12 and 24 months in COPD patients living with frailty vs non-frail COPD patients.'}], 'secondaryOutcomes': [{'measure': 'All-cause long-term mortality in COPD patients living with frailty vs non-frail COPD patients.', 'timeFrame': '12 and 24 months', 'description': 'All-cause long-term mortality at 12 and 24 months in COPD patients living with frailty vs non-frail COPD patients.'}, {'measure': 'Cardiovascular mortality in COPD patients living with frailty vs non-frail COPD patients.', 'timeFrame': '12 and 24 months', 'description': 'Long-term cardiovascular mortality at 12 and 24 months in COPD patients living with frailty vs non-frail COPD patients.'}, {'measure': 'Prevalence of frailty in COPD.', 'timeFrame': 'Baseline, at 12 and 24 months', 'description': 'Prevalence of frailty in COPD.'}, {'measure': 'Deaths due to COPD in COPD patients living with frailty vs non-frail COPD patients.', 'timeFrame': '12 and 24 months', 'description': 'Number of deaths due to COPD at 12 and 24 months in COPD patients living with frailty vs non-frail COPD patients.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Role of Frailty in COPD']}, 'referencesModule': {'references': [{'pmid': '11253156', 'type': 'BACKGROUND', 'citation': 'Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.'}, {'pmid': '12806071', 'type': 'BACKGROUND', 'citation': 'Mitnitski AB, Mogilner AJ, Rockwood K. Accumulation of deficits as a proxy measure of aging. ScientificWorldJournal. 2001 Aug 8;1:323-36. doi: 10.1100/tsw.2001.58.'}, {'pmid': '23764209', 'type': 'BACKGROUND', 'citation': 'Morley JE, Vellas B, van Kan GA, Anker SD, Bauer JM, Bernabei R, Cesari M, Chumlea WC, Doehner W, Evans J, Fried LP, Guralnik JM, Katz PR, Malmstrom TK, McCarter RJ, Gutierrez Robledo LM, Rockwood K, von Haehling S, Vandewoude MF, Walston J. Frailty consensus: a call to action. J Am Med Dir Assoc. 2013 Jun;14(6):392-7. doi: 10.1016/j.jamda.2013.03.022.'}, {'pmid': '29477493', 'type': 'BACKGROUND', 'citation': 'Marengoni A, Vetrano DL, Manes-Gravina E, Bernabei R, Onder G, Palmer K. The Relationship Between COPD and Frailty: A Systematic Review and Meta-Analysis of Observational Studies. Chest. 2018 Jul;154(1):21-40. doi: 10.1016/j.chest.2018.02.014. Epub 2018 Mar 1.'}, {'pmid': '33880018', 'type': 'BACKGROUND', 'citation': 'Luo J, Zhang D, Tang W, Dou LY, Sun Y. Impact of Frailty on the Risk of Exacerbations and All-Cause Mortality in Elderly Patients with Stable Chronic Obstructive Pulmonary Disease. Clin Interv Aging. 2021 Apr 13;16:593-601. doi: 10.2147/CIA.S303852. eCollection 2021.'}, {'pmid': '30433830', 'type': 'BACKGROUND', 'citation': 'Kennedy CC, Novotny PJ, LeBrasseur NK, Wise RA, Sciurba FC, Benzo RP. Frailty and Clinical Outcomes in Chronic Obstructive Pulmonary Disease. Ann Am Thorac Soc. 2019 Feb;16(2):217-224. doi: 10.1513/AnnalsATS.201803-175OC.'}, {'pmid': '34914976', 'type': 'BACKGROUND', 'citation': 'Lee SY, Nyunt MSZ, Gao Q, Gwee X, Chua DQL, Yap KB, Wee SL, Ng TP. Co-occurrence of Physical Frailty and COPD and Association With Disability and Mortality: Singapore Longitudinal Ageing Study. Chest. 2022 May;161(5):1225-1238. doi: 10.1016/j.chest.2021.12.633. Epub 2021 Dec 13.'}, {'pmid': '21743290', 'type': 'BACKGROUND', 'citation': 'Galizia G, Cacciatore F, Testa G, Della-Morte D, Mazzella F, Langellotto A, Raucci C, Gargiulo G, Ferrara N, Rengo F, Abete P. Role of clinical frailty on long-term mortality of elderly subjects with and without chronic obstructive pulmonary disease. Aging Clin Exp Res. 2011 Apr;23(2):118-25. doi: 10.1007/BF03351076.'}, {'pmid': '26355016', 'type': 'BACKGROUND', 'citation': 'Lahousse L, Ziere G, Verlinden VJ, Zillikens MC, Uitterlinden AG, Rivadeneira F, Tiemeier H, Joos GF, Hofman A, Ikram MA, Franco OH, Brusselle GG, Stricker BH. Risk of Frailty in Elderly With COPD: A Population-Based Study. J Gerontol A Biol Sci Med Sci. 2016 May;71(5):689-95. doi: 10.1093/gerona/glv154. Epub 2015 Sep 9.'}, {'pmid': '22561964', 'type': 'BACKGROUND', 'citation': 'Divo M, Cote C, de Torres JP, Casanova C, Marin JM, Pinto-Plata V, Zulueta J, Cabrera C, Zagaceta J, Hunninghake G, Celli B; BODE Collaborative Group. Comorbidities and risk of mortality in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2012 Jul 15;186(2):155-61. doi: 10.1164/rccm.201201-0034OC. Epub 2012 May 3.'}, {'pmid': '16129869', 'type': 'BACKGROUND', 'citation': 'Rockwood K, Song X, MacKnight C, Bergman H, Hogan DB, McDowell I, Mitnitski A. A global clinical measure of fitness and frailty in elderly people. CMAJ. 2005 Aug 30;173(5):489-95. doi: 10.1503/cmaj.050051.'}, {'pmid': '23395245', 'type': 'RESULT', 'citation': 'Clegg A, Young J, Iliffe S, Rikkert MO, Rockwood K. Frailty in elderly people. Lancet. 2013 Mar 2;381(9868):752-62. doi: 10.1016/S0140-6736(12)62167-9. Epub 2013 Feb 8.'}, {'pmid': '38917212', 'type': 'DERIVED', 'citation': 'Verduri A, Clini E, Carter B, Hewitt J. Influence of frailty on cardiovascular events and mortality in patients with Chronic Obstructive Pulmonary Disease (COPD): Study protocol for a multicentre European observational study. PLoS One. 2024 Jun 25;19(6):e0300945. doi: 10.1371/journal.pone.0300945. eCollection 2024.'}], 'seeAlsoLinks': [{'url': 'http://www.goldcopd.org', 'label': 'Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD)'}]}, 'descriptionModule': {'briefSummary': 'Observational study on the influence of frailty on cardiovascular risk in COPD.', 'detailedDescription': 'The study will investigate the influence that frailty can have on cardiovascular risk in patients with COPD. The project will assess the association between frailty and all-cause mortality, and the relationship between frailty and cardiovascular mortality, by comparing COPD patients living with frailty vs non-frail COPD patients.\n\nThe study participants will be outpatients with diagnosis of COPD according to the Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) guidelines (www.goldcopd.org).\n\nFrailty will be measured using the Clinical Frailty Scale (grades 1-9). Patients who are terminally ill (CFS = 9) will be excluded. Cognitive function will be explored using the Montreal Cognitive Assessment (MoCA) test.\n\nThe follow up will be at 12 and 24 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'COPD outpatients with diagnosis of COPD according to the GOLD guidelines (www.goldcopd.org).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with age ≥18 years, with diagnosis of COPD of at least 1 year, in stable condition, without acute exacerbation in the last 30 days and/or all-cause hospitalisation in the last 3 months\n* Smoking history of ≥ 10 pack/years\n* Diagnosis of COPD according to GOLD guidelines (www.goldcopd.org)\n* Individuals able to provide their written informed consent.\n\nExclusion Criteria:\n\n* Concurrent diagnosis of interstitial lung disease\n* Presence of restrictive pattern on spirometry\n* No history of smoking habit\n* Individuals not able to provide their written informed consent.'}, 'identificationModule': {'nctId': 'NCT05922202', 'acronym': 'FrCVCOPD', 'briefTitle': 'Influence of Frailty on Cardiovascular Events and Mortality in Patients With COPD.', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Ospedaliero-Universitaria di Modena'}, 'officialTitle': 'Influence of Frailty on Cardiovascular Events and Mortality in Patients With Chronic Obstructive Pulmonary Disease (COPD): A Multicentre Observational Study.', 'orgStudyIdInfo': {'id': '6390'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'COPD outpatients', 'description': 'Outpatients with COPD. COPD diagnosis confirmed by spirometry and according to Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) guidelines.', 'interventionNames': ['Other: Assessment of cardiovascular events, cardiovascular mortality, all-cause mortality, and mortality due to COPD at 12 and 24 months']}], 'interventions': [{'name': 'Assessment of cardiovascular events, cardiovascular mortality, all-cause mortality, and mortality due to COPD at 12 and 24 months', 'type': 'OTHER', 'description': 'At 12 and 24 months of follow up, cardiovascular events (including hospital admissions), deaths due to cardiovascular disease, deaths due to all-cause, deaths due to COPD will be recorded in COPD outpatients group.', 'armGroupLabels': ['COPD outpatients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41100', 'city': 'Modena', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Alessia Verduri, PhD', 'role': 'CONTACT', 'email': 'alessia.verduri@unimore.it'}, {'name': 'Valentina Ruggieri', 'role': 'CONTACT', 'email': 'valentina.ruggieri@unimore.it'}], 'facility': 'Respiratory Unit - Hospital Policlinico Modena', 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}], 'centralContacts': [{'name': 'Alessia Verduri, PhD', 'role': 'CONTACT', 'email': 'alessia.verduri@unimore.it', 'phone': '+390594225769'}, {'name': 'Valentina Ruggieri', 'role': 'CONTACT', 'email': 'valentina.ruggieri@unimore.it'}], 'overallOfficials': [{'name': 'Alessia Verduri, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Respiratory Unit-University of Modena (Italy) - Hospital Policlinico Modena'}, {'name': 'Alessia Verduri, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Respiratory Unit-University of Modena (Italy)-Hospital Policlinico Modena'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Ospedaliero-Universitaria di Modena', 'class': 'OTHER'}, 'collaborators': [{'name': 'Campus Bio-Medico Universitario di Roma-Medicina Interna - Servizio di Pneumologia', 'class': 'UNKNOWN'}, {'name': "Ospedale Sant'Andrea - Azienda Sanitaria Locale di Vercelli-Reparto di Pneumologia", 'class': 'UNKNOWN'}, {'name': 'Hospitals - Aneurin Bevan University Heath Board (Wales) - United Kingdom', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr Alessia Verduri', 'investigatorFullName': 'Alessia Verduri', 'investigatorAffiliation': 'Azienda Ospedaliero-Universitaria di Modena'}}}}