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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40+
SponsorAzienda Ospedaliero-Universitaria di Modena

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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

    Other intervention

    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.

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: COPD outpatients1 intervention

Trial outcomes

Primary outcomes

1

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

1

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
2

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
3

Prevalence of frailty in COPD.

Prevalence of frailty in COPD.

Time frame
Baseline, at 12 and 24 months
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Azienda Ospedaliero-Universitaria di Modena

Lead sponsor

Campus Bio-Medico Universitario di Roma-Medicina Interna - Servizio di Pneumologia

Collaborator

Ospedale Sant'Andrea - Azienda Sanitaria Locale di Vercelli-Reparto di Pneumologia

Collaborator

Hospitals - Aneurin Bevan University Heath Board (Wales) - United Kingdom

Collaborator