Influence of Frailty on Cardiovascular Events and Mortality in Patients With Chronic Obstructive Pulmonary Disease (COPD): A Multicentre Observational Study.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Role of Frailty in COPD
- Sponsor
- Azienda Ospedaliero-Universitaria di Modena
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Number of cardiovascular events in COPD patients living with frailty vs non-frail COPD. patients.
- Status
- Recruiting
- Last Updated
- 9 months ago
Overview
Brief Summary
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.
Investigators
Alessia Verduri
Dr Alessia Verduri
Azienda Ospedaliero-Universitaria di Modena
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.
Outcomes
Primary Outcomes
Number of cardiovascular events in COPD patients living with frailty vs non-frail COPD. patients.
Time Frame: 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 Outcomes
- Prevalence of frailty in COPD.(Baseline, at 12 and 24 months)
- 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)
- Deaths due to COPD in COPD patients living with frailty vs non-frail COPD patients.(12 and 24 months)