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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
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Study Description
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Brief Summary:
In a randomized, sham-controlled trial the investigators will test whether supplemental oxygen given during cardiopulmonary exercise testing will improve exercise performance and physiological parameters in patients with pulmonary arterial or chronic thromboembolic pulmonary hypertension.

Condition or disease Intervention/treatment Phase
Pulmonary Arterial and Chronic Thromboembolic Pulmonary Hypertension Chronic Cardiorespiratory Disease Procedure: Supplemental oxygen via a mask Phase 2

Study Design
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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

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Supplemental oxygen
Supplemental oxygen will be applied via a mask during CPET
 Procedure: Supplemental oxygen via a mask
Placebo Comparator: Sham room air
Room air will be applied similarly to oxygen
 Procedure: Supplemental oxygen via a mask


Outcome Measures
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Primary Outcome Measures :
  1. Watt [ Time Frame: 1 day ]
  2. exercise time [ Time Frame: 1 day ]

Secondary Outcome Measures :
  1. Peak oxygen uptake [ Time Frame: 1 day ]
  2. Respiratory exchange ratio [ Time Frame: 1 day ]
  3. ventilatory equivalent of carbon dioxide (VE/VCO2) slope [ Time Frame: 1 day ]
  4. end-tidal pressures of carbon dioxide (PET CO2) [ Time Frame: 1 day ]
  5. Changes in arterial blood parameters [ Time Frame: 1 day ]

Eligibility Criteria
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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
Criteria

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
Contacts and Locations
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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


Locations
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Switzerland
University Hospital Zurich, Division of Pneumology
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
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Principal Investigator: Silvia Ulrich Somaini, MD University Hospital Zurich, Division of Pneumology
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Vascular Diseases
 Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases