About this trial
Observational study on the influence of frailty on cardiovascular risk in COPD.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
COPD outpatients with diagnosis of COPD according to the GOLD guidelines (www.goldcopd.org).
Trial design
Cohort
Prospective
Treatments tested in this trial
Assessment of cardiovascular events, cardiovascular mortality, all-cause mortality, and mortality due to COPD at 12 and 24 months
Other interventionAt 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
Prevalence of frailty in COPD.
Prevalence of frailty in COPD.
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.
Sponsors and contacts
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Azienda Ospedaliero-Universitaria di Modena
Lead sponsor
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