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

Recruiting

• Conditions: Role of Frailty in COPD
• Interventions: Other: Assessment of cardiovascular events, cardiovascular mortality, all-cause mortality, and mortality due to COPD at 12 and 24 months

• Registration Number: NCT05922202
• Lead Sponsor: Azienda Ospedaliero-Universitaria di Modena

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.

Study Timeline

• Study First Submitted: 2023-06-19
• Study First Submitted QC: 2023-06-19
• Study First Posted: 2023-06-28
• Study Start: 2024-02-23
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-03
• Last Update Posted: 2024-05-06
• Primary Completion: 2025-11-15
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COPD outpatients	Assessment of cardiovascular events, cardiovascular mortality, all-cause mortality, and mortality due to COPD at 12 and 24 months	Outpatients with COPD. COPD diagnosis confirmed by spirometry and according to Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) guidelines.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Prevalence of frailty in COPD.	Baseline, at 12 and 24 months	Prevalence of frailty in COPD.
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.
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.

Trial Locations

Locations (1)

Respiratory Unit - Hospital Policlinico Modena; 🇮🇹 Modena, Italy