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NCT Number: NCT06595784

The HELlenic Thoracic Society Initiative for CΟPD and CVD

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Cardiovascular Diseases Cardiovascular Diseases (CVD) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

35 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Respiratory Medicine, Medical School, Democritus University of Thrace, University General Hospital, Alexandroupoli, Greece

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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,
  • 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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

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

Study contacts

Contact information is provided by the study sponsor or research team.

Andriana Tsimpouki

CONTACT

[email protected]

+302107487723

Stylianos Loukides

CONTACT

[email protected]

+306944380549

Sponsors and collaborators

Lead sponsor

Hellenic Thoracic Society

Other

Registry information

Acronym: HELICOPD

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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