Respiratory Unit - Hospital Policlinico Modena
Modena, 41100, Italy
Location status: Recruiting
NCT Number: NCT05922202
Observational study on the influence of frailty on cardiovascular risk in COPD.
Interested in participating?
Request Info40 year and older
All sexes
Observational
Modena, 41100, Italy
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: 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.
Time frame: 12 and 24 months
Long-term cardiovascular mortality at 12 and 24 months in COPD patients living with frailty vs non-frail COPD patients.
Time frame: Baseline, at 12 and 24 months
Prevalence of frailty in COPD.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Alessia Verduri, PhD
CONTACT
Valentina Ruggieri
CONTACT
Azienda Ospedaliero-Universitaria di Modena
Other
Influence of Frailty on Cardiovascular Events and Mortality in Patients With Chronic Obstructive Pulmonary Disease (COPD): A Multicentre Observational Study.
Acronym: FrCVCOPD
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.