Impact of frailty on heart health and survival in COPD patients
Official title: Influence of Frailty on Cardiovascular Events and Mortality in Patients With Chronic Obstructive Pulmonary Disease (COPD): A Multicentre Observational Study.
Run by Azienda Ospedaliero-Universitaria di Modena · NCT05922202 · Data updated 2026-11-12
This study looks at how being frail affects heart health and survival in people with COPD to see if frail patients have a higher risk of heart problems and death compared to those who are not frail.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 40 Years and up |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Azienda Ospedaliero-Universitaria di Modena Academic / other |
| Locations | 1 site (Modena) |
| Status | Recruiting |
| Started | February 23, 2024 |
| Main results expected | November 15, 2025 |
| Study ends | June 30, 2026 |
| Registry record updated | August 5, 2025 |
| Trial ID | NCT05922202 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with a stable COPD diagnosis of at least one year and a smoking history of 10 pack-years or more.
✕Probably not a fit
Patients with concurrent interstitial lung disease or those unable to provide informed consent may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study investigates how frailty affects cardiovascular risk and mortality in patients diagnosed with Chronic Obstructive Pulmonary Disease (COPD). It will compare frail COPD patients to those who are not frail, assessing the association between frailty and both all-cause and cardiovascular mortality. The study will utilize the Clinical Frailty Scale to measure frailty and the Montreal Cognitive Assessment to evaluate cognitive function. Participants will be followed for 12 and 24 months to gather data on cardiovascular events and mortality rates.
Why it matters
Potential benefit: If successful, this study could help identify high-risk COPD patients and improve management strategies to enhance their cardiovascular health and survival.
How similar studies have gone: While the specific focus on frailty in COPD patients is relatively novel, previous studies have indicated that frailty is a significant factor in cardiovascular outcomes, suggesting potential for success.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Respiratory Unit - Hospital Policlinico Modena
Modena, Italy Recruiting
Study contacts
- Principal investigator: Alessia Verduri, PhD — Respiratory Unit-University of Modena (Italy) - Hospital Policlinico Modena
- Study coordinator: Alessia Verduri, PhD
- Email: alessia.verduri@unimore.it
- Phone: +390594225769
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.