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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

Tracking Information
First Submitted Date  ICMJE October 4, 2012
First Posted Date  ICMJE December 12, 2012
Last Update Posted Date August 12, 2016
Study Start Date  ICMJE December 2012
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 12, 2012)
  • Watt [ Time Frame: 1 day ]
  • exercise time [ Time Frame: 1 day ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 11, 2012)
Watt and exercise time [ Time Frame: 1 day ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 2, 2015)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2012)
  • Peak oxygen uptake [ Time Frame: 1 day ]
  • Respiratory exchange ratio [ Time Frame: 1 day ]
  • VE/VCO2 slope [ Time Frame: 1 day ]
  • PET CO2 [ Time Frame: 1 day ]
  • Changes in arterial blood parameters [ Time Frame: 1 day ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Short-term Oxygen During CPET in Pulmonary Hypertension
Official Title  ICMJE Effect of Short-term Oxygen Therapy on Cardiopulmonary Exercise Capacity in Patients With Pulmonary Arterial and Chronic Thromboembolic Pulmonary Hypertension
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Pulmonary Arterial and Chronic Thromboembolic Pulmonary Hypertension
  • Chronic Cardiorespiratory Disease
Intervention  ICMJE Procedure: Supplemental oxygen via a mask
Study Arms  ICMJE
  • Experimental: Supplemental oxygen
    Supplemental oxygen will be applied via a mask during CPET
    Intervention: Procedure: Supplemental oxygen via a mask
  • Placebo Comparator: Sham room air
    Room air will be applied similarly to oxygen
    Intervention: Procedure: Supplemental oxygen via a mask
Publications * Ulrich S, Hasler ED, Saxer S, Furian M, Müller-Mottet S, Keusch S, Bloch KE. Effect of breathing oxygen-enriched air on exercise performance in patients with precapillary pulmonary hypertension: randomized, sham-controlled cross-over trial. Eur Heart J. 2017 Apr 14;38(15):1159-1168. doi: 10.1093/eurheartj/ehx099.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 11, 2012)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01748474
Other Study ID Numbers  ICMJE KEK-ZH-NR. 2012-0251
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Zurich
Study Sponsor  ICMJE University of Zurich
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Silvia Ulrich Somaini, MD University Hospital Zurich, Division of Pneumology
PRS Account University of Zurich
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP