University Hospital Zurich, Division of Pneumology
Zurich, Canton of Zurich, 8091, Switzerland
Completed
NCT Number: NCT01884012
Effect of Long-term Oxygen Therapy on Exercise Capacity and Quality of Life in Patients With Pulmonary Arterial and Chronic Thromboembolic Pulmonary Hypertension
In this randomized-controlled, cross-over trial the investigators test the effect of long-term oxygen therapy (> 16h/day) given for 5 weeks with a wash-out period between phases of 2 weeks on exercise performance and quality of life and many physiological parameters in patients with pulmonary arterial and chronic thromboembolic pulmonary hypertension.
Completed
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Notify MeKey information
Age range
16 year–85 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Adult patients with established diagnosis of pulmonary arterial or chronic thromboembolic pulmonary hypertension (class I and IV according to the latest WHO classification scheme of Dana Point 2008) on optimized medical therapy and in stable condition for at least 4 weeks, who desaturate in the 6 minute walking test by =4% to values <92%.
Exclusion criteria
- Patients in unstable conditions requiring frequent therapeutic adaption
- pregnant women
- patients with pulmonary venous hypertension due to left heart diseases
- patients with relevant concomitant lung disease and severe daytime hypoxemia
Treatment and study plan
long term oxygen therapy
ProcedurePrimary outcomes
-
6 minute walk test
Time frame: 5 weeks
6 minute walk distance according to american thoracic society (ATS) guidelines
-
Quality of life
Time frame: 5 weeks
QoL assessed by the short form of the medical outcome questionnaire (SF-36) physical functioning scale
Secondary outcomes
-
Daily activity
Time frame: 5 week
measured by actigraphy
-
hemodynamics by echocardiography
Time frame: 5 weeks
Full echocardiographic assessment
-
quality of life
Time frame: 5 weeks
SF-36
-
arterial blood gas
Time frame: 5 weeks
partial pressure of oxygen (PaO2)
-
operating hours of oxygen concentrator
Time frame: 5 weeks
efficacy of oxygen treatment
-
mean nocturnal oxygen saturation
Time frame: 5 weeks
Ambulatory Sleep Study
-
tests of cognitive performance
Time frame: 5 weeks
STROOP-Test
-
Quality of life
Time frame: 5 weeks
Minnesota living with heart failure questionnaire
-
Venous blood
Time frame: 5 weeks
N-terminal brain natriuretic peptide (NT-proBNP)
Sponsors and collaborators
Lead sponsor
University of Zurich
Other
Registry information
Important dates
- Study start
- 2013
- Primary completion
- 2017
- Study completion
- 2017
- First posted
- Jun 21, 2013
- Registry last updated
- May 5, 2017
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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