Clinical trial NCT05922202: Influence of Frailty on Cardiovascular Events and Mortality in Patients With COPD.
Official title: Influence of Frailty on Cardiovascular Events and Mortality in Patients With Chronic Obstructive Pulmonary Disease (COPD): A Multicentre Observational Study.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Role of Frailty in COPD
Lead sponsor: Azienda Ospedaliero-Universitaria di Modena
Sponsor class: OTHER
Collaborators: name: Campus Bio-Medico Universitario di Roma-Medicina Interna - Servizio di Pneumologia
name: Ospedale Sant'Andrea - Azienda Sanitaria Locale di Vercelli-Reparto di Pneumologia
name: Hospitals - Aneurin Bevan University Heath Board (Wales) - United Kingdom
First posted: 2023-06-28
Enrollment: 300
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COPD outpatients with diagnosis of COPD according to the GOLD guidelines (www.goldcopd.org).

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.

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.

Primary outcomes:
measure: Number of cardiovascular events in COPD patients living with frailty vs non-frail COPD. patients.
timeFrame: 12 and 24 months
Secondary outcomes:
measure: All-cause long-term mortality in COPD patients living with frailty vs non-frail COPD patients.
timeFrame: 12 and 24 months
measure: Cardiovascular mortality in COPD patients living with frailty vs non-frail COPD patients.
timeFrame: 12 and 24 months
measure: Prevalence of frailty in COPD.
timeFrame: Baseline, at 12 and 24 months
measure: Deaths due to COPD in COPD patients living with frailty vs non-frail COPD patients.
timeFrame: 12 and 24 months
Other outcomes:
Locations:
city: Modena
country: Italy
facility: Respiratory Unit - Hospital Policlinico Modena
Study officials:
affiliation: Respiratory Unit-University of Modena (Italy) - Hospital Policlinico Modena
name: Alessia Verduri, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Respiratory Unit-University of Modena (Italy)-Hospital Policlinico Modena
name: Alessia Verduri, PhD
role: STUDY_DIRECTOR
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