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RecruitingNCT06595784HELICOPDUpdated Sep 16, 2026

The HELlenic Thoracic Society Initiative for CΟPD and CVD

An observational study in Chronic Obstructive Pulmonary Disease (COPD) and Cardiovascular Diseases (CVD), sponsored by Hellenic Thoracic Society. Recruiting at 2 sites in Greece. Open to participants aged 35 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-09-16.

Sponsored by Hellenic Thoracic Society · Observational

From the registry’s dates

  • Started Oct 2024; still recruiting 1 year 11 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
900
Ages
35 Years to 99 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Chronic Obstructive Pulmonary Disease (COPD)
  • Cardiovascular Diseases (CVD)

Keywords

  • Chronic obstructive pulmonary disease
  • COPD
  • Cardiovascular disease
  • CVD
  • Protocol
  • Real-World Data
03

In context

Pulmonary Disease, Chronic Obstructive

4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.

This study's planned enrollment of 900 is above the median of 180 across 1,066 observational studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

This is the only study on the registry with Hellenic Thoracic Society as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with COPD and cardiovascular comorbidities in Greece

Eligibility criteria

Inclusion criteria

Patients should cumulatively meet the following three (3) criteria to be enrolled in the study:

  1. 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)
  2. Adults aged >35 years at the time of inclusion in the study,
  3. 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:

  1. Without at least one cardiovascular comorbidity,
  2. With history of lung cancer
  3. With any other active malignancy and undergoing treatment (chemotherapy/radiotherapy/immunotherapy)
  4. With any thoracic or abdominal surgery planned during study follow-up period
  5. With participation in any COPD-related interventional study at study entry or during study duration.
  6. Without signed informed consent for their participation in the study.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
900 participants (estimated)
Target follow-up
24 Months
Patient registry
Yes

Groups and cohorts

  • COPD patients with cardiovascular comorbidities
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to 24 months

  2. 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.

    Time frame: Up to 24 months

Secondary outcomes

  1. Unscheduled hospital admission due to COPD

    Time frame: Up to 24 months

  2. Unscheduled hospital admission due to any other reason

    Time frame: Up to 24 months

Other outcomes

  1. Death (due to any cause)

    Time frame: Up to 24 months

  2. Healthcare resource utilization related costs

    Time frame: Up to 24 months

07

Study locations

2 of 2 sites recruiting
  • Department of Respiratory Medicine, Medical School, Democritus University of Thrace, University General Hospital
    Alexandroupoli, Greece
    Recruiting
  • 5th Pulmonary Department, "Sotiria" Chest Diseases Hospital, Athens, Greece
    Athens, Greece
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06595784
Lead sponsor
Hellenic Thoracic Society
Responsible party
Sponsor
First posted
Sep 19, 2024
Start date
Oct 15, 2024
Primary completion
Oct 2026 (estimated)
Completion
Oct 2026 (estimated)
Last update
Sep 16, 2026

Study contacts

Stylianos Loukides
Contact
loukstel@med.uoa.gr
+306944380549
Andriana Tsimpouki
Contact
htsinfo@otenet.gr
+302107487723
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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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