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

This study is currently recruiting participants.
Verified October 2012 by Wissenschaftliches Institut Bethanien e.V
Sponsor:
Collaborator:
Actelion Pharmaceuticals Deutschland GmbH
Information provided by (Responsible Party):
Wissenschaftliches Institut Bethanien e.V
ClinicalTrials.gov Identifier:
NCT01423071
First received: August 23, 2011
Last updated: October 25, 2012
Last verified: October 2012
History of Changes

August 23, 2011
October 25, 2012
August 2011
February 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01423071 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Chronic Obstructive Pulmonary Disease and Pulmonary Hypertension: Prevalence and Quality of Life
Chronisch Obstruktive Lungenerkrankung Und Pulmonale Hypertonie: Prävalenz Und Lebensqualität

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.
Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

In- and out-patients at the investigational center
  • Hypertension, Pulmonary
  • Pulmonary Disease, Chronic Obstructive
Not Provided
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
February 2013
February 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Christina Priegnitz, Dr. med. +49-212-636662 institut@klinik-bethanien.de
Germany
 
NCT01423071
WI_PH+COPD_73/2011
No
Wissenschaftliches Institut Bethanien e.V
Wissenschaftliches Institut Bethanien e.V
Actelion Pharmaceuticals Deutschland GmbH
Principal Investigator: Winfried J Randerath, Prof. Dr. med. Wissenschaftliches Institut Bethanien e.V
Wissenschaftliches Institut Bethanien e.V
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP