Effect of Short-term Oxygen During CPET in Pulmonary Hypertension (ExOx-CPET)
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ClinicalTrials.gov Identifier: NCT01748474 |
Recruitment Status :
Completed
First Posted : December 12, 2012
Last Update Posted : August 12, 2016
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Condition or disease | Intervention/treatment | Phase |
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Pulmonary Arterial and Chronic Thromboembolic Pulmonary Hypertension Chronic Cardiorespiratory Disease | Procedure: Supplemental oxygen via a mask | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Supportive Care |
Official Title: | Effect of Short-term Oxygen Therapy on Cardiopulmonary Exercise Capacity in Patients With Pulmonary Arterial and Chronic Thromboembolic Pulmonary Hypertension |
Study Start Date : | December 2012 |
Actual Primary Completion Date : | March 2016 |
Actual Study Completion Date : | July 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: Supplemental oxygen
Supplemental oxygen will be applied via a mask during CPET
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Procedure: Supplemental oxygen via a mask |
Placebo Comparator: Sham room air
Room air will be applied similarly to oxygen
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Procedure: Supplemental oxygen via a mask |
- Watt [ Time Frame: 1 day ]
- exercise time [ Time Frame: 1 day ]
- Peak oxygen uptake [ Time Frame: 1 day ]
- Respiratory exchange ratio [ Time Frame: 1 day ]
- ventilatory equivalent of carbon dioxide (VE/VCO2) slope [ Time Frame: 1 day ]
- end-tidal pressures of carbon dioxide (PET CO2) [ Time Frame: 1 day ]
- Changes in arterial blood parameters [ Time Frame: 1 day ]

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Ages Eligible for Study: | 20 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
- diagnosis of pulmonary arterial 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 week
- desaturate in the 6 minute walking test by at least 4% to values <92%
Exclusion criteria:
- unstable conditions
- pregnant women
- patients with pulmonary venous hypertension
- patients with relevant concomitant lung disease and severe daytime hypoxemia

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01748474
Switzerland | |
University Hospital Zurich, Division of Pneumology | |
Zurich, ZH, Switzerland, 8091 |
Principal Investigator: | Silvia Ulrich Somaini, MD | University Hospital Zurich, Division of Pneumology |
Responsible Party: | University of Zurich |
ClinicalTrials.gov Identifier: | NCT01748474 |
Other Study ID Numbers: |
KEK-ZH-NR. 2012-0251 |
First Posted: | December 12, 2012 Key Record Dates |
Last Update Posted: | August 12, 2016 |
Last Verified: | August 2016 |
Hypertension, Pulmonary Hypertension Vascular Diseases |
Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases |