The HELlenic Thoracic Society Initiative for CΟPD and CVD
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age35-99
SponsorHellenic Thoracic Society
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial population
Patients with COPD and cardiovascular comorbidities in Greece
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
900 Participants
are grouped into 1 trial groupGroup A: COPD patients with cardiovascular comorbidities
Trial outcomes
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 months2
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 monthsSecondary outcomes
1
Unscheduled hospital admission due to COPD
Time frame
Up to 24 months2
Unscheduled hospital admission due to any other reason
Time frame
Up to 24 monthsOther outcomes
1
Death (due to any cause)
Time frame
Up to 24 months2
Healthcare resource utilization related costs
Time frame
Up to 24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov