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OpenTrials
Completed

NCT Number: NCT01423071

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bethanien Hospital, Clinic for Pneumology and Allergology, Center for Sleep Medicine and Respiratory Care, Institute for Pneumology at the University Witten/Herdecke

Solingen, North Rhine-Westphalia, 42699, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Wissenschaftliches Institut Bethanien e.V

Other

Collaborators

  • Actelion Pharmaceuticals Deutschland GmbH

Registry information

Official study title

Chronisch Obstruktive Lungenerkrankung Und Pulmonale Hypertonie: Prävalenz Und Lebensqualität

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Aug 25, 2011
Registry last updated
Jun 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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