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Recruiting NCT05922202

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

— Observational Role of Frailty in COPD

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Assessment of cardiovascular events, cardiovascular mortality, all-cause mortality, and mortality due to COPD at 12 and 24 months.
Who it may be relevant to
Registry conditions: Role of Frailty in COPD. Basic parameters: from 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Influence of Frailty on Cardiovascular Events and Mortality in Patients With Chronic Obstructive Pulmonary Disease (COPD): A Multicentre Observational Study.

Overview

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

Detailed description

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.

The study participants will be outpatients with diagnosis of COPD according to the Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) guidelines (www.goldcopd.org).

Frailty 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.

The follow up will be at 12 and 24 months.

Interventions

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

Primary outcome measures

  • Number of cardiovascular events in COPD patients living with frailty vs non-frail COPD. patients. [Time frame: 12 and 24 months]
Secondary outcome measures (4)
  • All-cause long-term mortality in COPD patients living with frailty vs non-frail COPD patients. [Time frame: 12 and 24 months]
  • Cardiovascular mortality in COPD patients living with frailty vs non-frail COPD patients. [Time frame: 12 and 24 months]
  • Prevalence of frailty in COPD. [Time frame: Baseline, at 12 and 24 months]
  • Deaths due to COPD in COPD patients living with frailty vs non-frail COPD patients. [Time frame: 12 and 24 months]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • Respiratory Unit - Hospital Policlinico Modena — Modena

Publications

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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

Identifiers

NCT: NCT05922202 · 6390

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗