FrCVCOPD: Influence of Frailty on Cardiovascular Events and Mortality in Patients With COPD.
Study Details
Study Description
Brief Summary
Observational study on the influence of frailty on cardiovascular risk in COPD.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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).
The follow up will be at 12 and 24 months.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
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.
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Outcome Measures
Primary Outcome Measures
- Number of cardiovascular events in COPD patients living with frailty vs non-frail COPD. patients. [12 and 24 months]
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.
Secondary Outcome Measures
- All-cause long-term mortality in COPD patients living with frailty vs non-frail COPD patients. [12 and 24 months]
All-cause long-term mortality at 12 and 24 months in COPD patients living with frailty vs non-frail COPD patients.
- Cardiovascular mortality in COPD patients living with frailty vs non-frail COPD patients. [12 and 24 months]
Long-term cardiovascular mortality at 12 and 24 months in COPD patients living with frailty vs non-frail COPD patients.
- Prevalence of frailty in COPD. [Baseline, at 12 and 24 months]
Prevalence of frailty in COPD.
- Deaths due to COPD in COPD patients living with frailty vs non-frail COPD patients. [12 and 24 months]
Number of deaths due to COPD at 12 and 24 months in COPD patients living with frailty vs non-frail COPD patients.
Eligibility Criteria
Criteria
Inclusion Criteria:
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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
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Smoking history of ≥ 10 pack/years
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Diagnosis of COPD according to GOLD guidelines (www.goldcopd.org)
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Individuals able to provide their written informed consent.
Exclusion Criteria:
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Concurrent diagnosis of asthma
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Concurrent diagnosis of interstitial lung disease
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Presence of restrictive pattern on spirometry
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No history of smoking habit
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Individuals not able to provide their written informed consent.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Azienda Ospedaliero-Universitaria di Modena
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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