Chronic Obstructive Pulmonary Disease (COPD)HELICOPDNCT06595784
The HELlenic Thoracic Society Initiative for CΟPD and CVD
An observational study of Chronic Obstructive Pulmonary Disease (COPD) and Cardiovascular Diseases (CVD), run by Hellenic Thoracic Society at 2 sites in Greece.
Trial summary
COPD is one of the most common respiratory diseases in Greece, and maybe more than half a million Greek citizens suffer both from COPD and CVD, however their characteristics and management remain unknown. Read more about this study
- Who is it for?
- Ages 35 to 99 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD), Cardiovascular Diseases (CVD)
- How many people
- 900 participants
- Where
- 2 sitesGreece
- Study dates
- 15 Oct 2024to Oct 2026
- How long will I take part?
- 24 Months
- 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 35 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with COPD and cardiovascular comorbidities in Greece
Who may be able to join
- Patients should cumulatively meet the following three (3) criteria to be enrolled in the study:
- To have been diagnosed with chronic obstructive pulmonary disease and at least one cardiovascular comorbidity (heart failure, atherosclerotic cardiovascular disease, atrial Fibrillation, severe valvular disease)
- Adults aged \>35 years at the time of inclusion in the study,
- With signed informed consent for their participation in the study. Exclusion criteria Patients with the below limitations are not eligible to participate in the study
- Patients:
- Without at least one cardiovascular comorbidity,
Show all 11Show fewer
- With history of lung cancer
- With any other active malignancy and undergoing treatment (chemotherapy/radiotherapy/immunotherapy)
- With any thoracic or abdominal surgery planned during study follow-up period
- With participation in any COPD-related interventional study at study entry or during study duration.
- Without signed informed consent for their participation in the study.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Greece2 sites, 2 recruiting
- Recruiting
Department of Respiratory Medicine, Medical School, Democritus University of Thrace, University General Hospital
Alexandroupoli
Paschalis Steiropoulos, Professor, +302551030377, steiropoulos@yahoo.com
- Recruiting
5th Pulmonary Department, "Sotiria" Chest Diseases Hospital, Athens, Greece
Athens
Georgios Hillas, +306937415725, ghillas70@yahoo.gr
About this study
COPD is one of the most common respiratory diseases in Greece, and maybe more than half a million Greek citizens suffer both from COPD and CVD, however their characteristics and management remain unknown. HELICOPD is a national, multicenter, prospective, non-interventional study designed to contribute to better understanding and depicting the demographic and clinical characteristics of this population, the COPD- and CVD-related adverse events in a two-years period, their quality of life and the healthcare resources use. The study is initiated and coordinated by the Hellenic Thoracic Society.
- Keywords
- Chronic obstructive pulmonary disease, COPD, Cardiovascular disease, CVD, Protocol, Real-World Data
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| COPD patients with cardiovascular comorbidities | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of moderate or severe COPD exacerbations
Moderate COPD exacerbation: typically requires outpatient management, it is characterized by an increased need for medication, specifically the use of systemic corticosteroids and/or antibiotics. Severe COPD exacerbation: indicated by an acute worsening of symptoms that requires hospitalization.
Measured: Up to 24 months
Number of cardiovascular complications/outcomes
Cardiovascular complications/outcomes, including a) acute coronary syndrome, b) ischemic stroke, c) pulmonary embolism, d) reperfusion, e) worsening of heart failure that required a visit to the Emergency Department (ED) or hospitalization (short or longer), f) other hospitalization in a cardiology clinic (causes other than acute coronary syndrome, reperfusion, and heart failure), g) death related to cardiovascular disease.
Measured: Up to 24 months
Secondary outcomes (2)
Unscheduled hospital admission due to COPD
Measured: Up to 24 months
Unscheduled hospital admission due to any other reason
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start15 Oct 2024
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies 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
- 900 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Hellenic Thoracic Society
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Georgios Hillas, Principal investigator, 5th Pulmonary Department, "Sotiria" Chest Diseases Hospital, Athens, GreecePaschalis Steiropoulos, Principal investigator, Department of Respiratory Medicine, Medical School, Democritus University of Thrace, University General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06595784
- Sponsor's protocol ID
- HTS001
- Acronym
- HELICOPD
- Status last verified
- Sep 2026
- First submitted
- 5 Sep 2024
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The HELlenic Thoracic Society Initiative for CΟPD and CVD
- ClinicalTrials.gov ID
- NCT06595784
- Acronym / sponsor ID
- HELICOPD / HTS001
- Keywords
- Chronic obstructive pulmonary disease, COPD, Cardiovascular disease, CVD, Protocol, Real-World Data
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Hellenic Thoracic SocietyUniversity, hospital or other
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 19 Sep 2024 (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.
COPD is one of the most common respiratory diseases in Greece, and maybe more than half a million Greek citizens suffer both from COPD and CVD, however their characteristics and management remain unknown. HELICOPD is a national, multicenter, prospective, non-interventional study designed to contribute to better understanding and depicting the demographic and clinical characteristics of this population, the COPD- and CVD-related adverse events in a two-years period, their quality of life and the healthcare resources use. The study is initiated and coordinated by the Hellenic Thoracic Society.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD patients with cardiovascular comorbidities | – | – |
Who may qualify
- Ages
- 35 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with COPD and cardiovascular comorbidities in Greece
Key inclusion criteria (11 listed)
- Patients should cumulatively meet the following three (3) criteria to be enrolled in the study:
- To have been diagnosed with chronic obstructive pulmonary disease and at least one cardiovascular comorbidity (heart failure, atherosclerotic cardiovascular disease, atrial Fibrillation, severe valvular disease)
- Adults aged \>35 years at the time of inclusion in the study,
- With signed informed consent for their participation in the study. Exclusion criteria Patients with the below limitations are not eligible to participate in the study
- Without at least one cardiovascular comorbidity,
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of moderate or severe COPD exacerbations
Time frame: Up to 24 months
Moderate COPD exacerbation: typically requires outpatient management, it is characterized by an increased need for medication, specifically the use of systemic corticosteroids and/or antibiotics. Severe COPD exacerbation: indicated by an acute worsening of symptoms that requires hospitalization.
Number of cardiovascular complications/outcomes
Time frame: Up to 24 months
Cardiovascular complications/outcomes, including a) acute coronary syndrome, b) ischemic stroke, c) pulmonary embolism, d) reperfusion, e) worsening of heart failure that required a visit to the Emergency Department (ED) or hospitalization (short or longer), f) other hospitalization in a cardiology clinic (causes other than acute coronary syndrome, reperfusion, and heart failure), g) death related to cardiovascular disease.
2 secondary outcomes
Unscheduled hospital admission due to COPD
Time frame: Up to 24 months
Unscheduled hospital admission due to any other reason
Time frame: Up to 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 16 Sep 2026.
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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.
Georgios Hillas principal investigator
5th Pulmonary Department, "Sotiria" Chest Diseases Hospital, Athens, Greece
Paschalis Steiropoulos principal investigator
Department of Respiratory Medicine, Medical School, Democritus University of Thrace, University General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease (COPD) and Cardiovascular Diseases (CVD), run by Hellenic Thoracic Society at 2 sites in Greece.
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 11 inclusion and 0 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 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece. 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 Stylianos Loukides (+306944380549, loukstel@med.uoa.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of moderate or severe COPD exacerbations (time frame: Up to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Sep 2026.