Effect of Short-term Oxygen During CPET in Pulmonary Hypertension
ExOx-CPET
Effect of Short-term Oxygen Therapy on Cardiopulmonary Exercise Capacity in Patients With Pulmonary Arterial and Chronic Thromboembolic Pulmonary Hypertension
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Dec 2012
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 4, 2012
CompletedStudy Start
First participant enrolled
December 1, 2012
CompletedFirst Posted
Study publicly available on registry
December 12, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedAugust 12, 2016
August 1, 2016
3.2 years
October 4, 2012
August 11, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Watt
1 day
exercise time
1 day
Secondary Outcomes (5)
Peak oxygen uptake
1 day
Respiratory exchange ratio
1 day
ventilatory equivalent of carbon dioxide (VE/VCO2) slope
1 day
end-tidal pressures of carbon dioxide (PET CO2)
1 day
Changes in arterial blood parameters
1 day
Study Arms (2)
Supplemental oxygen
EXPERIMENTALSupplemental oxygen will be applied via a mask during CPET
Sham room air
PLACEBO COMPARATORRoom air will be applied similarly to oxygen
Interventions
Eligibility Criteria
You may qualify if:
- 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%
You may not qualify if:
- unstable conditions
- pregnant women
- patients with pulmonary venous hypertension
- patients with relevant concomitant lung disease and severe daytime hypoxemia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Zurich, Division of Pneumology
Zurich, Canton of Zurich, 8091, Switzerland
Related Publications (1)
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.
PMID: 28329240DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Silvia Ulrich Somaini, MD
University Hospital Zurich, Division of Pneumology
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 4, 2012
First Posted
December 12, 2012
Study Start
December 1, 2012
Primary Completion
March 1, 2016
Study Completion
July 1, 2016
Last Updated
August 12, 2016
Record last verified: 2016-08