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NCT Number: NCT05922202

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

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

Recruiting

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Respiratory Unit - Hospital Policlinico Modena

Modena, 41100, Italy

Location status: Recruiting

Location contact

Alessia Verduri, PhD

CONTACT

[email protected]

Valentina Ruggieri

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. Prevalence of frailty in COPD.

    Time frame: Baseline, at 12 and 24 months

    Prevalence of frailty in COPD.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alessia Verduri, PhD

CONTACT

[email protected]

+390594225769

Valentina Ruggieri

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero-Universitaria di Modena

Other

Collaborators

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

Registry information

Official study title

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

Acronym: FrCVCOPD

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jun 28, 2023
Registry last updated
Aug 5, 2025

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.