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NCT05922202 | RECRUITING | Role of Frailty in COPD


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

Modena University Hospital

Information provided by (Responsible Party):

Alessia Verduri

Brief Summary:

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

Condition or disease

Role of Frailty in COPD

Intervention/treatment

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

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 Type : OBSERVATIONAL
Estimated Enrollment : 300 participants
Official Title : Influence of Frailty on Cardiovascular Events and Mortality in Patients With Chronic Obstructive Pulmonary Disease (COPD): A Multicentre Observational Study.
Actual Study Start Date : 2024-02-23
Estimated Primary Completion Date : 2025-11-15
Estimated Study Completion Date : 2026-06-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 40 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.

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

Location Details

NCT05922202


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Locations


RECRUITING

Italy,

Respiratory Unit - Modena Polyclinic Hospital

Modena, Italy, 41100

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