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

Primary Purpose

Pulmonary Arterial and Chronic Thromboembolic Pulmonary Hypertension, Chronic Cardiorespiratory Disease

Status
Completed
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
Supplemental oxygen via a mask
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pulmonary Arterial and Chronic Thromboembolic Pulmonary Hypertension

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Zurich, Division of Pneumology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Supplemental oxygen

Sham room air

Arm Description

Supplemental oxygen will be applied via a mask during CPET

Room air will be applied similarly to oxygen

Outcomes

Primary Outcome Measures

Watt
exercise time

Secondary Outcome Measures

Peak oxygen uptake
Respiratory exchange ratio
ventilatory equivalent of carbon dioxide (VE/VCO2) slope
end-tidal pressures of carbon dioxide (PET CO2)
Changes in arterial blood parameters

Full Information

First Posted
October 4, 2012
Last Updated
August 11, 2016
Sponsor
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT01748474
Brief Title
Effect of Short-term Oxygen During CPET in Pulmonary Hypertension
Acronym
ExOx-CPET
Official Title
Effect of Short-term Oxygen Therapy on Cardiopulmonary Exercise Capacity in Patients With Pulmonary Arterial and Chronic Thromboembolic Pulmonary Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial and Chronic Thromboembolic Pulmonary Hypertension, Chronic Cardiorespiratory Disease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Silvia Ulrich Somaini, MD
Organizational Affiliation
University Hospital Zurich, Division of Pneumology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Zurich, Division of Pneumology
City
Zurich
State/Province
ZH
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
28329240
Citation
Ulrich S, Hasler ED, Saxer S, Furian M, Muller-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.
Results Reference
derived

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Effect of Short-term Oxygen During CPET in Pulmonary Hypertension

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