Examining respiratory and heart changes in COPD patients
The Impact of Dual Bronchodilation on Respiratory and Cardiovascular Systems in Patients With Newly Diagnosed Moderate-to-severe Chronic Obstructive Pulmonary Disease
This study looks at how chronic obstructive pulmonary disease (COPD) affects heart health and quality of life in people aged 40 and older with moderate to severe COPD.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Lithuanian University of Health Sciences Academic / other |
| Locations | 1 site (Kaunas, Kaunas County) |
| Trial ID | NCT06072690 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the relationship between chronic obstructive pulmonary disease (COPD) and cardiovascular diseases (CVDs) in patients aged 40 and older. It aims to understand how COPD affects cardiac function and quality of life, particularly focusing on patients with moderate to severe COPD. The study will assess various factors, including lung function and cardiovascular health, to better understand the interplay between these conditions. By identifying these relationships, the study hopes to highlight the importance of addressing cardiovascular health in COPD management.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 40 and older with a smoking history of at least 10 pack-years and newly diagnosed moderate to severe COPD.
Not a fit: Patients with active lung infections, certain types of lung cancer, or other significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for patients with COPD, potentially enhancing their cardiovascular health and overall quality of life.
How similar studies have performed: While the relationship between COPD and cardiovascular health has been explored, this specific observational approach focusing on dual bronchodilation effects is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 40 years and older * Smoking index of 10 pack-years and more * Newly diagnosed chronic obstructive pulmonary disease (COPD) with forced expiratory volume in 1 second (FEV1) 30-79 percent of predicted and forced expiratory volume in 1 second to forced vital capacity ratio (FEV1/FVC) less than 70 percent of predicted. Exclusion Criteria: * Active lung infection * Present or previously treated lung cancer * Alpha-1 antitrypsin deficiency * Diagnosed interstitial lung disease * Previously diagnosed asthma * Diagnosed chronic hypercapnic respiratory failure * Treatment with systemic glucocorticoids * Unstable ischaemic heart disease * Pregnancy * Present cardiac arrhythmias * Uncontrolled arterial hypertension * Dementia and other mental states that determine patient's inability to consent * Other medical conditions that in the opinion of the investigator disqualify the subject for inclusion
Where this trial is running
Kaunas, Kaunas County
- Lithuanian University of Health Sciences — Kaunas, Kaunas County, Lithuania (Recruiting)
Study contacts
- Principal investigator: Skaidrius Miliauskas, PhD, Prof. — Lithuanian University of Health Sciences, Medical Academy, Department of Pulmonology
- Study coordinator: Skaidrius Miliauskas, PhD, Prof.
- Email: skaidrius.miliauskas@lsmu.lt
- Phone: +37037326269
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.