Influence of Frailty on Cardiovascular Events and Mortality in Patients With COPD.

NCT05922202 | Recruiting

• 1 other identifier: 6390
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Observational study on the influence of frailty on cardiovascular risk in COPD.

Conditions

Role of Frailty in COPD

Outcome Measures

Primary Outcomes (1)

• Number of cardiovascular events in COPD patients living with frailty vs non-frail COPD. patients.

  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.

  12 and 24 months

Secondary Outcomes (4)

• All-cause long-term mortality in COPD patients living with frailty vs non-frail COPD patients.

  12 and 24 months

• Cardiovascular mortality in COPD patients living with frailty vs non-frail COPD patients.

  12 and 24 months

• Prevalence of frailty in COPD.

  Baseline, at 12 and 24 months

• Deaths due to COPD in COPD patients living with frailty vs non-frail COPD patients.

  12 and 24 months

Study Arms (1)

COPD outpatients

Outpatients with COPD. COPD diagnosis confirmed by spirometry and according to Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) guidelines.

Other: Assessment of cardiovascular events, cardiovascular mortality, all-cause mortality, and mortality due to COPD at 12 and 24 months

Interventions

Assessment of cardiovascular events, cardiovascular mortality, all-cause mortality, and mortality due to COPD at 12 and 24 months OTHER

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.

COPD outpatients

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

COPD outpatients with diagnosis of COPD according to the GOLD guidelines (www.goldcopd.org).

You may qualify if:

• 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
• Smoking history of ≥ 10 pack/years
• Diagnosis of COPD according to GOLD guidelines (www.goldcopd.org)
• Individuals able to provide their written informed consent.

You may not qualify if:

• Concurrent diagnosis of interstitial lung disease
• Presence of restrictive pattern on spirometry
• No history of smoking habit
• Individuals not able to provide their written informed consent.

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria di Modena: lead
• Campus Bio-Medico Universitario di Roma-Medicina Interna - Servizio di Pneumologia: collaborator
• Ospedale Sant'Andrea - Azienda Sanitaria Locale di Vercelli-Reparto di Pneumologia: collaborator
• Hospitals - Aneurin Bevan University Heath Board (Wales) - United Kingdom: collaborator

Study Sites (1)

Respiratory Unit - Hospital Policlinico Modena

Modena, 41100, Italy

RECRUITING

Related Publications (13)

• 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: 11253156 BACKGROUND

• 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: 12806071 BACKGROUND

• 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: 23764209 BACKGROUND

• 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: 29477493 BACKGROUND

• 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: 33880018 BACKGROUND

• 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: 30433830 BACKGROUND

• 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: 34914976 BACKGROUND

• 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: 21743290 BACKGROUND

• 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: 26355016 BACKGROUND

• 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: 22561964 BACKGROUND

• 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: 16129869 BACKGROUND

• 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: 23395245 RESULT

• 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.

  PMID: 38917212 DERIVED

Related Links

• Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD)

Study Officials

• Alessia Verduri, PhD

  Respiratory Unit-University of Modena (Italy) - Hospital Policlinico Modena

  PRINCIPAL INVESTIGATOR

• Alessia Verduri, PhD

  Respiratory Unit-University of Modena (Italy)-Hospital Policlinico Modena

  STUDY DIRECTOR

Central Study Contacts

Alessia Verduri, PhD

CONTACT

+390594225769; alessia.verduri@unimore.it

Valentina Ruggieri

CONTACT

valentina.ruggieri@unimore.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Alessia Verduri

Study Record Dates

• First Submitted: June 19, 2023
• First Posted: June 28, 2023
• Study Start: February 23, 2024
• Primary Completion: November 15, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: August 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

IT (1)