Role of Frailty in COPDFrCVCOPDNCT05922202
Influence of Frailty on Cardiovascular Events and Mortality in Patients With COPD.
An observational study of Role of Frailty in COPD, run by Azienda Ospedaliero-Universitaria di Modena at 1 site in Italy.
Trial summary
Observational study on the influence of frailty on cardiovascular risk in COPD. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Role of Frailty in COPD
- What is being tested?
- Assessment of cardiovascular events, cardiovascular mortality, all-cause mortality, and mortality due to COPD at 12 and 24 months
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 23 Feb 2024to 30 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: COPD outpatients with diagnosis of COPD according to the GOLD guidelines (www.goldcopd.org).
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Valentina Ruggieri contact
Italy1 site, 1 recruiting
- Recruiting
Respiratory Unit - Hospital Policlinico Modena
Modena, 41100
Alessia Verduri, PhD, alessia.verduri@unimore.it
Valentina Ruggieri, valentina.ruggieri@unimore.it
About this study
Official title: 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.
Read the 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.
- Conditions
- Role of Frailty in COPD
- Being tested
- Assessment of cardiovascular events, cardiovascular mortality, all-cause mortality, and mortality due to COPD at 12 and 24 months
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of cardiovascular events, cardiovascular mortality, all-cause mortality, and mortality due to COPD at 12 and 24 monthsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| COPD outpatients | Outpatients with COPD. COPD diagnosis confirmed by spirometry and according to Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) guidelines. Receives: Other: Assessment of cardiovascular events, cardiovascular mortality, all-cause mortality, and mortality due to COPD at 12 and 24 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 and 24 months
Secondary outcomes (4)
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.
Measured: 12 and 24 months
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.
Measured: 12 and 24 months
Prevalence of frailty in COPD.
Prevalence of frailty in COPD.
Measured: Baseline, at 12 and 24 months
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.
Measured: 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start23 Feb 2024
- Primary completion15 Nov 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Role of Frailty in COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria di Modena
- Sponsor type
- University, hospital or other
- Collaborators
- Campus Bio-Medico University, Ospedale Sant'Andrea - Azienda Sanitaria Locale di Vercelli-Reparto di Pneumologia, Hospitals - Aneurin Bevan University Heath Board (Wales) - United Kingdom
- Responsible party
- Principal investigator, Alessia Verduri, Azienda Ospedaliero-Universitaria di Modena
- Investigators
- Alessia Verduri, PhD, Principal investigator, Respiratory Unit-University of Modena (Italy) - Hospital Policlinico ModenaAlessia Verduri, PhD, Study director, Respiratory Unit-University of Modena (Italy)-Hospital Policlinico Modena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05922202
- Sponsor's protocol ID
- 6390
- Acronym
- FrCVCOPD
- Status last verified
- Aug 2025
- First submitted
- 19 Jun 2023
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.
PubMed 11253156Mitnitski AB, Mogilner AJ, Rockwood K. Accumulation of deficits as a proxy measure of aging. ScientificWorldJournal. 2001 Aug 8;1:323-36. doi: 10.1100/tsw.2001.58.
PubMed 12806071Morley JE, Vellas B, van Kan GA, Anker SD, Bauer JM, Bernabei R, Cesari M, Chumlea WC, Doehner W, Evans J, Fried LP, Guralnik JM, Katz PR, Malmstrom TK, McCarter RJ, Gutierrez Robledo LM, Rockwood K, von Haehling S, Vandewoude MF, Walston J. Frailty consensus: a call to action. J Am Med Dir Assoc. 2013 Jun;14(6):392-7. doi: 10.1016/j.jamda.2013.03.022.
PubMed 23764209Marengoni A, Vetrano DL, Manes-Gravina E, Bernabei R, Onder G, Palmer K. The Relationship Between COPD and Frailty: A Systematic Review and Meta-Analysis of Observational Studies. Chest. 2018 Jul;154(1):21-40. doi: 10.1016/j.chest.2018.02.014. Epub 2018 Mar 1.
PubMed 29477493Luo J, Zhang D, Tang W, Dou LY, Sun Y. Impact of Frailty on the Risk of Exacerbations and All-Cause Mortality in Elderly Patients with Stable Chronic Obstructive Pulmonary Disease. Clin Interv Aging. 2021 Apr 13;16:593-601. doi: 10.2147/CIA.S303852. eCollection 2021.
PubMed 33880018Kennedy CC, Novotny PJ, LeBrasseur NK, Wise RA, Sciurba FC, Benzo RP. Frailty and Clinical Outcomes in Chronic Obstructive Pulmonary Disease. Ann Am Thorac Soc. 2019 Feb;16(2):217-224. doi: 10.1513/AnnalsATS.201803-175OC.
PubMed 30433830Lee SY, Nyunt MSZ, Gao Q, Gwee X, Chua DQL, Yap KB, Wee SL, Ng TP. Co-occurrence of Physical Frailty and COPD and Association With Disability and Mortality: Singapore Longitudinal Ageing Study. Chest. 2022 May;161(5):1225-1238. doi: 10.1016/j.chest.2021.12.633. Epub 2021 Dec 13.
PubMed 34914976Galizia G, Cacciatore F, Testa G, Della-Morte D, Mazzella F, Langellotto A, Raucci C, Gargiulo G, Ferrara N, Rengo F, Abete P. Role of clinical frailty on long-term mortality of elderly subjects with and without chronic obstructive pulmonary disease. Aging Clin Exp Res. 2011 Apr;23(2):118-25. doi: 10.1007/BF03351076.
PubMed 21743290Lahousse L, Ziere G, Verlinden VJ, Zillikens MC, Uitterlinden AG, Rivadeneira F, Tiemeier H, Joos GF, Hofman A, Ikram MA, Franco OH, Brusselle GG, Stricker BH. Risk of Frailty in Elderly With COPD: A Population-Based Study. J Gerontol A Biol Sci Med Sci. 2016 May;71(5):689-95. doi: 10.1093/gerona/glv154. Epub 2015 Sep 9.
PubMed 26355016Divo M, Cote C, de Torres JP, Casanova C, Marin JM, Pinto-Plata V, Zulueta J, Cabrera C, Zagaceta J, Hunninghake G, Celli B; BODE Collaborative Group. Comorbidities and risk of mortality in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2012 Jul 15;186(2):155-61. doi: 10.1164/rccm.201201-0034OC. Epub 2012 May 3.
PubMed 22561964Rockwood K, Song X, MacKnight C, Bergman H, Hogan DB, McDowell I, Mitnitski A. A global clinical measure of fitness and frailty in elderly people. CMAJ. 2005 Aug 30;173(5):489-95. doi: 10.1503/cmaj.050051.
PubMed 16129869Clegg A, Young J, Iliffe S, Rikkert MO, Rockwood K. Frailty in elderly people. Lancet. 2013 Mar 2;381(9868):752-62. doi: 10.1016/S0140-6736(12)62167-9. Epub 2013 Feb 8.
PubMed 23395245Verduri A, Clini E, Carter B, Hewitt J. Influence of frailty on cardiovascular events and mortality in patients with Chronic Obstructive Pulmonary Disease (COPD): Study protocol for a multicentre European observational study. PLoS One. 2024 Jun 25;19(6):e0300945. doi: 10.1371/journal.pone.0300945. eCollection 2024.
PubMed 38917212
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Frailty on Cardiovascular Events and Mortality in Patients With Chronic Obstructive Pulmonary Disease (COPD): A Multicentre Observational Study.
- ClinicalTrials.gov ID
- NCT05922202
- Acronym / sponsor ID
- FrCVCOPD / 6390
- Conditions
- Role of Frailty in COPD
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero-Universitaria di ModenaUniversity, hospital or other
- Collaborators
- Campus Bio-Medico University, Ospedale Sant'Andrea - Azienda Sanitaria Locale di Vercelli-Reparto di Pneumologia, Hospitals - Aneurin Bevan University Heath Board (Wales) - United Kingdom
- Study start
- 23 Feb 2024 (actual)
- Primary completion
- 15 Nov 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 28 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Observational study on the influence of frailty on cardiovascular risk in COPD.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD outpatients | – | Other: Assessment of cardiovascular events, cardiovascular mortality, all-cause mortality, and mortality due to COPD at 12 and 24 monthsOutpatients with COPD. COPD diagnosis confirmed by spirometry and according to Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) guidelines. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COPD outpatients with diagnosis of COPD according to the GOLD guidelines (www.goldcopd.org).
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of cardiovascular events, cardiovascular mortality, all-cause mortality, and mortality due to COPD at 12 and 24 monthsAt 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. | Other | COPD outpatients |
Primary outcome
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.
4 secondary outcomes
All-cause long-term mortality in COPD patients living with frailty vs non-frail COPD patients.
Time frame: 12 and 24 months
Cardiovascular mortality in COPD patients living with frailty vs non-frail COPD patients.
Time frame: 12 and 24 months
Prevalence of frailty in COPD.
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Background: PubMed 11253156Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.
- Background: PubMed 12806071Mitnitski AB, Mogilner AJ, Rockwood K. Accumulation of deficits as a proxy measure of aging. ScientificWorldJournal. 2001 Aug 8;1:323-36. doi: 10.1100/tsw.2001.58.
- Background: PubMed 23764209Morley JE, Vellas B, van Kan GA, Anker SD, Bauer JM, Bernabei R, Cesari M, Chumlea WC, Doehner W, Evans J, Fried LP, Guralnik JM, Katz PR, Malmstrom TK, McCarter RJ, Gutierrez Robledo LM, Rockwood K, von Haehling S, Vandewoude MF, Walston J. Frailty consensus: a call to action. J Am Med Dir Assoc. 2013 Jun;14(6):392-7. doi: 10.1016/j.jamda.2013.03.022.
- Background: PubMed 29477493Marengoni A, Vetrano DL, Manes-Gravina E, Bernabei R, Onder G, Palmer K. The Relationship Between COPD and Frailty: A Systematic Review and Meta-Analysis of Observational Studies. Chest. 2018 Jul;154(1):21-40. doi: 10.1016/j.chest.2018.02.014. Epub 2018 Mar 1.
- Background: PubMed 33880018Luo J, Zhang D, Tang W, Dou LY, Sun Y. Impact of Frailty on the Risk of Exacerbations and All-Cause Mortality in Elderly Patients with Stable Chronic Obstructive Pulmonary Disease. Clin Interv Aging. 2021 Apr 13;16:593-601. doi: 10.2147/CIA.S303852. eCollection 2021.
- Background: PubMed 30433830Kennedy CC, Novotny PJ, LeBrasseur NK, Wise RA, Sciurba FC, Benzo RP. Frailty and Clinical Outcomes in Chronic Obstructive Pulmonary Disease. Ann Am Thorac Soc. 2019 Feb;16(2):217-224. doi: 10.1513/AnnalsATS.201803-175OC.
- Background: PubMed 34914976Lee SY, Nyunt MSZ, Gao Q, Gwee X, Chua DQL, Yap KB, Wee SL, Ng TP. Co-occurrence of Physical Frailty and COPD and Association With Disability and Mortality: Singapore Longitudinal Ageing Study. Chest. 2022 May;161(5):1225-1238. doi: 10.1016/j.chest.2021.12.633. Epub 2021 Dec 13.
- Background: PubMed 21743290Galizia G, Cacciatore F, Testa G, Della-Morte D, Mazzella F, Langellotto A, Raucci C, Gargiulo G, Ferrara N, Rengo F, Abete P. Role of clinical frailty on long-term mortality of elderly subjects with and without chronic obstructive pulmonary disease. Aging Clin Exp Res. 2011 Apr;23(2):118-25. doi: 10.1007/BF03351076.
- Background: PubMed 26355016Lahousse L, Ziere G, Verlinden VJ, Zillikens MC, Uitterlinden AG, Rivadeneira F, Tiemeier H, Joos GF, Hofman A, Ikram MA, Franco OH, Brusselle GG, Stricker BH. Risk of Frailty in Elderly With COPD: A Population-Based Study. J Gerontol A Biol Sci Med Sci. 2016 May;71(5):689-95. doi: 10.1093/gerona/glv154. Epub 2015 Sep 9.
- Background: PubMed 22561964Divo M, Cote C, de Torres JP, Casanova C, Marin JM, Pinto-Plata V, Zulueta J, Cabrera C, Zagaceta J, Hunninghake G, Celli B; BODE Collaborative Group. Comorbidities and risk of mortality in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2012 Jul 15;186(2):155-61. doi: 10.1164/rccm.201201-0034OC. Epub 2012 May 3.
- Background: PubMed 16129869Rockwood K, Song X, MacKnight C, Bergman H, Hogan DB, McDowell I, Mitnitski A. A global clinical measure of fitness and frailty in elderly people. CMAJ. 2005 Aug 30;173(5):489-95. doi: 10.1503/cmaj.050051.
- Results publication: PubMed 23395245Clegg A, Young J, Iliffe S, Rikkert MO, Rockwood K. Frailty in elderly people. Lancet. 2013 Mar 2;381(9868):752-62. doi: 10.1016/S0140-6736(12)62167-9. Epub 2013 Feb 8.
- Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Valentina Ruggieri contact
Alessia Verduri, PhD principal investigator
Respiratory Unit-University of Modena (Italy) - Hospital Policlinico Modena
Alessia Verduri, PhD study director
Respiratory Unit-University of Modena (Italy)-Hospital Policlinico Modena
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Role of Frailty in COPD, run by Azienda Ospedaliero-Universitaria di Modena at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alessia Verduri, PhD (+390594225769, alessia.verduri@unimore.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of cardiovascular events in COPD patients living with frailty vs non-frail COPD. patients. (time frame: 12 and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05922202, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.