Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
Chronisch Obstruktive Lungenerkrankung Und Pulmonale Hypertonie: Prävalenz Und Lebensqualität
| Verified date | June 2015 |
| Source | Wissenschaftliches Institut Bethanien e.V |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Germany: Ethics Commission |
| Study type | Observational |
The purpose of this study is to determine the prevalence of pulmonary hypertension (PH) among patients suffering from Chronic Obstructive Pulmonary Disease (COPD) and to assess the quality of life in those patients with concomitant PH compared to COPD patients without PH and those only suffering from pulmonary arterial hypertension (PAH) respectively.
| Status | Completed |
| Enrollment | 220 |
| Est. completion date | January 2015 |
| Est. primary completion date | January 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Age = 18 years - Known or newly diagnosed COPD or PAH - Written informed consent - Present long-term oxygen treatment is no exclusion criterion Exclusion Criteria: - Age < 18 years - Right-heart catheterization not reasonable - Pregnancy, Lactation - Life expectancy <12 months due to any diseases aside from COPD - Any medical, psychological or other condition, which limits the patient's ability to provide informed consent - No written informed consent provided - Current participation in another clinical trial |
Observational Model: Case Control, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Germany | Bethanien Hospital, Clinic for Pneumology and Allergology, Center for Sleep Medicine and Respiratory Care, Institute for Pneumology at the University Witten/Herdecke | Solingen | NRW |
| Lead Sponsor | Collaborator |
|---|---|
| Wissenschaftliches Institut Bethanien e.V | Actelion Pharmaceuticals Deutschland GmbH |
Germany,
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* Note: There are 18 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Prevalence of PH | Prevalence of PH as defined by ESC/ERS guidelines (mean pulmonary arterial pressure =25 mmHg, assessed by right-heart catheterization) among the subgroup of COPD GOLD III and IV patients. | At baseline | No |
| Secondary | Quality of life | Explorative data analysis to assess correlation between quality of life and PH, by comparison of COPD patients with and without PH and a reference group of patients with only PAH. | One year | No |
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