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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
  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:

U.S. FDA Resources

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.


Estimated Enrollment: 300
Study Start Date: August 2011
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (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

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01423071

Contacts
Contact: Christina Priegnitz, Dr. med. +49-212-636662 institut@klinik-bethanien.de

Locations
Germany
Bethanien Hospital, Clinic for Pneumology and Allergology, Center for Sleep Medicine and Respiratory Care, Institute for Pneumology at the University Witten/Herdecke Recruiting
Solingen, NRW, Germany, 42699
Contact: Christina Priegnitz, Dr. med.         institut@klinik-bethanien.de    
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
Study First Received: August 23, 2011
Last Updated: October 25, 2012
Health Authority: Germany: Ethics Commission

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

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

ClinicalTrials.gov processed this record on May 23, 2013