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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supplemental oxygen | Experimental | Supplemental oxygen 3 liters/minute given via a nasal cannula for 16 hours a day |
|
| Sham room air | Sham Comparator | Room air given at a flow rate of 3 liters per minute for 16 hours a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| long term oxygen therapy | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| 6 minute walk test | 6 minute walk distance according to american thoracic society (ATS) guidelines | 5 weeks |
| Quality of life | QoL assessed by the short form of the medical outcome questionnaire (SF-36) physical functioning scale | 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Daily activity | measured by actigraphy | 5 week |
| hemodynamics by echocardiography | Full echocardiographic assessment | 5 weeks |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Silvia Ulrich Somaini, MD | University Hospital Zurich, Division of Pneumology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Zurich, Division of Pneumology | Zurich | Canton of Zurich | 8091 | Switzerland |
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| quality of life | SF-36 | 5 weeks |
| arterial blood gas | partial pressure of oxygen (PaO2) | 5 weeks |
| operating hours of oxygen concentrator | efficacy of oxygen treatment | 5 weeks |
| mean nocturnal oxygen saturation | Ambulatory Sleep Study | 5 weeks |
| tests of cognitive performance | STROOP-Test | 5 weeks |
| Quality of life | Minnesota living with heart failure questionnaire | 5 weeks |
| Venous blood | N-terminal brain natriuretic peptide (NT-proBNP) | 5 weeks |