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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01423071
First Posted: August 25, 2011
Last Update Posted: June 18, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Actelion Pharmaceuticals Deutschland GmbH
Information provided by (Responsible Party):
Wissenschaftliches Institut Bethanien e.V
  Purpose
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.

Condition
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 ]
    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 ]
    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)
Groups/Cohorts
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
In- and out-patients at the investigational center
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01423071


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

Publications:

Responsible Party: Wissenschaftliches Institut Bethanien e.V
ClinicalTrials.gov Identifier: NCT01423071     History of Changes
Other Study ID Numbers: WI_PH+COPD_73/2011
First Submitted: August 23, 2011
First Posted: August 25, 2011
Last Update Posted: June 18, 2015
Last Verified: June 2015

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

Additional relevant MeSH terms:
Hypertension
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Hypertension, Pulmonary
Chronic Disease
Vascular Diseases
Cardiovascular Diseases
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes