Chronic Obstructive Pulmonary Disease and Pulmonary Hypertension: Prevalence and Quality of Life

Completed

• Conditions: Hypertension, Pulmonary; Pulmonary Disease, Chronic Obstructive

• Registration Number: NCT01423071
• Lead Sponsor: Wissenschaftliches Institut Bethanien e.V

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-23
• Study First Submitted QC: 2011-08-23
• Study First Posted: 2011-08-25
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-17
• Last Update Posted: 2015-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of PH	At baseline	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.

Secondary Outcome Measures

Name	Time	Method
Quality of life	One year	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.

Trial Locations

Locations (1)

Bethanien Hospital, Clinic for Pneumology and Allergology, Center for Sleep Medicine and Respiratory Care, Institute for Pneumology at the University Witten/Herdecke; 🇩🇪 Solingen, NRW, Germany