NCT05922202

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

Influence of Frailty on Cardiovascular Events and Mortality in Patients With Chronic Obstructive Pulmonary Disease (COPD): A Multicentre Observational Study.

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Azienda Ospedaliero-Universitaria di Modena · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Role of Frailty in COPD

Interventions

Type	Name	Description
OTHER	Assessment 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.

Timeline

• Start date: 2024-02-23
• Primary completion: 2025-11-15
• Completion: 2026-06-30
• First posted: 2023-06-28
• Last updated: 2025-08-05

Locations

1 site across 1 country: Italy