Role of Frailty in COPD
Conditions
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.
Interventions
OTHERAssessment 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.
Sponsors
Campus Bio-Medico Universitario di Roma-Medicina Interna - Servizio di Pneumologia
Ospedale Sant'Andrea - Azienda Sanitaria Locale di Vercelli-Reparto di Pneumologia
Hospitals - Aneurin Bevan University Heath Board (Wales) - United Kingdom
Azienda Ospedaliero-Universitaria di Modena
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Italy
Contacts
Primary ContactAlessia Verduri, PhD
Backup ContactValentina Ruggieri
Outcome results
None listed