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

Study Overview
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Brief Summary
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Observational study on the influence of frailty on cardiovascular risk in COPD.

Detailed Description
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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.

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

Conditions
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Role of Frailty in COPD

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


Participation Criteria
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Eligibility Criteria
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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 asthma 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COPD outpatients<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause long-term mortality in COPD patients living with frailty vs non-frail COPD patients. | All-cause long-term mortality at 12 and 24 months 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. | Long-term cardiovascular mortality at 12 and 24 months in COPD patients living with frailty vs non-frail COPD patients. | 12 and 24 months | 
| Prevalence of frailty in COPD. | 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. | Number of deaths due to COPD at 12 and 24 months in COPD patients living with frailty vs non-frail COPD patients. | 12 and 24 months |