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

This study has been completed.
Actelion Pharmaceuticals Deutschland GmbH
Information provided by (Responsible Party):
Wissenschaftliches Institut Bethanien e.V Identifier:
First received: August 23, 2011
Last updated: June 17, 2015
Last verified: June 2015
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.

Hypertension, Pulmonary
Pulmonary Disease, Chronic Obstructive

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Chronisch Obstruktive Lungenerkrankung Und Pulmonale Hypertonie: Prävalenz Und Lebensqualität

Resource links provided by NLM:

Further study details as provided by Wissenschaftliches Institut Bethanien e.V:

Primary Outcome Measures:
  • Prevalence of PH [ Time Frame: At baseline ] [ Designated as safety issue: No ]
    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:
  • Quality of life [ Time Frame: One year ] [ Designated as safety issue: No ]
    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.

Enrollment: 220
Study Start Date: August 2011
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
COPD with PH
COPD patients with confirmed diagnosis of PH.
COPD without PH
COPD patients without confirmed diagnosis of PH
PAH without COPD
PAH patients who do not suffer from COPD


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
In- and out-patients at the investigational center

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01423071

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, 42699
Sponsors and Collaborators
Wissenschaftliches Institut Bethanien e.V
Actelion Pharmaceuticals Deutschland GmbH
Principal Investigator: Winfried J Randerath, Prof. Dr. med. Wissenschaftliches Institut Bethanien e.V
  More Information


Responsible Party: Wissenschaftliches Institut Bethanien e.V Identifier: NCT01423071     History of Changes
Other Study ID Numbers: WI_PH+COPD_73/2011
Study First Received: August 23, 2011
Last Updated: June 17, 2015
Health Authority: Germany: Ethics Commission

Keywords provided by Wissenschaftliches Institut Bethanien e.V:
Pulmonary Hypertension
Chronic obstructive pulmonary disease
Quality of life

Additional relevant MeSH terms:
Chronic Disease
Hypertension, Pulmonary
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Cardiovascular Diseases
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Vascular Diseases processed this record on November 27, 2015