Clinical trial NCT06595784: The HELlenic Thoracic Society Initiative for CΟPD and CVD
Official title: The HELlenic Thoracic Society Initiative for CΟPD and CVD
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Cardiovascular Diseases (CVD)
Keywords: Chronic obstructive pulmonary disease
COPD
Cardiovascular disease
CVD
Protocol
Real-World Data
Lead sponsor: Hellenic Thoracic Society
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 900
Sex: ALL
Minimum age (years): 35
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with COPD and cardiovascular comorbidities in Greece

Brief 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.


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 \&gt;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.

Primary outcomes:
measure: Number of moderate or severe COPD exacerbations
timeFrame: Up to 24 months
measure: Number of cardiovascular complications/outcomes
timeFrame: Up to 24 months
Secondary outcomes:
measure: Unscheduled hospital admission due to COPD
timeFrame: Up to 24 months
measure: Unscheduled hospital admission due to any other reason
timeFrame: Up to 24 months
Other outcomes:
measure: Death (due to any cause)
timeFrame: Up to 24 months
measure: Healthcare resource utilization related costs
timeFrame: Up to 24 months
Locations:
city: Alexandroupolis
country: Greece
facility: Department of Respiratory Medicine, Medical School, Democritus University of Thrace, University General Hospital
city: Ioannina
country: Greece
facility: Respiratory Medicine Department University Hospital of Ioannina
Study officials:
affiliation: Respiratory Medicine Department, University Hospital of Ioannina
name: Konstantinos Kostikas
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Respiratory Medicine, Medical School, Democritus University of Thrace, University General Hospital
name: Paschalis Steiropoulos
role: PRINCIPAL_INVESTIGATOR
References: