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

August 2, 2025 updated by: Alessia Verduri, Azienda Ospedaliero-Universitaria di Modena

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

COPD outpatients with diagnosis of COPD according to the GOLD guidelines (www.goldcopd.org).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
COPD outpatients
Outpatients with COPD. COPD diagnosis confirmed by spirometry and according to Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) guidelines.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of cardiovascular events in COPD patients living with frailty vs non-frail COPD. patients.
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.
12 and 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause long-term mortality 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.
12 and 24 months
Cardiovascular mortality 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.
12 and 24 months
Prevalence of frailty in COPD.
Time Frame: Baseline, at 12 and 24 months
Prevalence of frailty in COPD.
Baseline, at 12 and 24 months
Deaths due to COPD in COPD patients living with frailty vs non-frail COPD patients.
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.
12 and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliero-Universitaria di Modena

Collaborators

Campus Bio-Medico Universitario di Roma-Medicina Interna - Servizio di Pneumologia
Ospedale Sant'Andrea - Azienda Sanitaria Locale di Vercelli-Reparto di Pneumologia
Hospitals - Aneurin Bevan University Heath Board (Wales) - United Kingdom

Investigators

  • Principal Investigator: Alessia Verduri, PhD, Respiratory Unit-University of Modena (Italy) - Hospital Policlinico Modena
  • Study Director: Alessia Verduri, PhD, Respiratory Unit-University of Modena (Italy)-Hospital Policlinico Modena

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 23, 2024

Primary Completion (Estimated)

November 15, 2025

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

June 19, 2023

First Submitted That Met QC Criteria

June 19, 2023

First Posted (Actual)

June 28, 2023

Study Record Updates

Last Update Posted (Actual)

August 5, 2025

Last Update Submitted That Met QC Criteria

August 2, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6390

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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