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OpenTrials
Completed

NCT Number: NCT01748474

Effect of Short-term Oxygen During CPET in 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.

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital Zurich, Division of Pneumology

Zurich, Canton of Zurich, 8091, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Supplemental oxygen via a mask

Procedure

Primary outcomes

  1. Watt

    Time frame: 1 day

  2. exercise time

    Time frame: 1 day

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

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

Acronym: ExOx-CPET

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Dec 12, 2012
Registry last updated
Aug 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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