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

Azienda Ospedaliero-Universitaria di Modena300 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

300

Conditions

Role of Frailty in COPD

Interventions

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

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.

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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.

Locations (1)

Respiratory Unit - Hospital Policlinico Modena

Modena, Italy

RECRUITING

Outcomes

Primary Outcomes

Number of cardiovascular events in COPD patients living with frailty vs non-frail COPD. patients.

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.

Time frame: 12 and 24 months

Secondary Outcomes

All-cause long-term mortality in COPD patients living with frailty vs non-frail COPD patients.

All-cause long-term mortality at 12 and 24 months in COPD patients living with frailty vs non-frail COPD patients.

Time frame: 12 and 24 months

Cardiovascular mortality in COPD patients living with frailty vs non-frail COPD patients.

Long-term cardiovascular mortality at 12 and 24 months in COPD patients living with frailty vs non-frail COPD patients.

Time frame: 12 and 24 months

Prevalence of frailty in COPD.

Time frame: Baseline, at 12 and 24 months

Deaths due to COPD in COPD patients living with frailty vs non-frail COPD patients.

Number of deaths due to COPD at 12 and 24 months in COPD patients living with frailty vs non-frail COPD patients.

Time frame: 12 and 24 months

Central Contacts

Alessia Verduri, PhD

CONTACT

+390594225769 alessia.verduri@unimore.it

Valentina Ruggieri

CONTACT

valentina.ruggieri@unimore.it

Data from ClinicalTrials.gov

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