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

August 11, 2016 updated by: University of Zurich

Effect of Short-term Oxygen Therapy on Cardiopulmonary Exercise Capacity in Patients With Pulmonary Arterial and Chronic Thromboembolic Pulmonary Hypertension

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • ZH
      • Zurich, ZH, Switzerland, 8091
        • University Hospital Zurich, Division of Pneumology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Watt
Time Frame: 1 day
1 day
exercise time
Time Frame: 1 day
1 day

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in arterial blood parameters
Time Frame: 1 day
1 day
Peak oxygen uptake
Time Frame: 1 day
1 day
Respiratory exchange ratio
Time Frame: 1 day
1 day
ventilatory equivalent of carbon dioxide (VE/VCO2) slope
Time Frame: 1 day
1 day
end-tidal pressures of carbon dioxide (PET CO2)
Time Frame: 1 day
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Investigators

  • Principal Investigator: Silvia Ulrich Somaini, MD, University Hospital Zurich, Division of Pneumology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

October 4, 2012

First Submitted That Met QC Criteria

December 11, 2012

First Posted (Estimate)

December 12, 2012

Study Record Updates

Last Update Posted (Estimate)

August 12, 2016

Last Update Submitted That Met QC Criteria

August 11, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KEK-ZH-NR. 2012-0251

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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