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

Azienda Ospedaliero-Universitaria di Modena

Status: Enrolling

Conditions: Role of Frailty in COPD

Treatments: Other: Assessment of cardiovascular events, cardiovascular mortality, all-cause mortality, and mortality due to COPD at 12 and 24 months

Study type: Observational

Funder types: Other

Identifiers

NCT05922202

6390

Details and patient eligibility

About

Observational study on the influence of frailty on cardiovascular risk in COPD.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

300 participants in 1 patient group

COPD outpatients

Description:

Outpatients with COPD. COPD diagnosis confirmed by spirometry and according to Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) guidelines.

Treatment:

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