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Effect of Short-term Oxygen During CPET in PH (ExOx-CPET)

This study is currently recruiting participants.
Verified October 2012 by University of Zurich
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01748474
First received: October 4, 2012
Last updated: December 12, 2012
Last verified: October 2012
History of Changes
  Purpose

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 Intervention Phase
Pulmonary Arterial and Chronic Thromboembolic Pulmonary Hypertension
 Procedure: Supplemental oxygen via a mask
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Watt [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • exercise time [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Peak oxygen uptake [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Respiratory exchange ratio [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • VE/VCO2 slope [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • PET CO2 [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Changes in arterial blood parameters [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: December 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01748474

Contacts
Contact: Silvia Ulrich Somaini, MD silvia.ulrich@usz.ch

Locations
Switzerland
University Hospital Zurich, Division of Pneumology Recruiting
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Silvia Ulrich Somaini, MD University Hospital Zurich, Division of Pneumology
  More Information

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01748474     History of Changes
Other Study ID Numbers: KEK-ZH-NR. 2012-0251
Study First Received: October 4, 2012
Last Updated: December 12, 2012
Health Authority: Switzerland: Swissmedic

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

ClinicalTrials.gov processed this record on May 22, 2013