Effect of Short-term Oxygen During CPET in Pulmonary Hypertension

Pulmonary Arterial and Chronic Thromboembolic Pulmonary Hypertension Clinical Trial

— ExOx-CPET  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01748474
• Other study ID #: KEK-ZH-NR. 2012-0251
• Status: Completed
• Phase: Phase 2
• First received: October 4, 2012
• Last updated: August 11, 2016
• Start date: December 2012
• Est. completion date: July 2016

Study information

• Verified date: August 2016
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Chronic Cardiorespiratory Disease
• Hypertension
• Hypertension, Pulmonary
• Pulmonary Arterial and Chronic Thromboembolic Pulmonary Hypertension

Intervention

Procedure:
• Supplemental oxygen via a mask

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Division of Pneumology	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Watt		1 day	No
Primary	exercise time		1 day	No
Secondary	Peak oxygen uptake		1 day	No
Secondary	Respiratory exchange ratio		1 day	No
Secondary	ventilatory equivalent of carbon dioxide (VE/VCO2) slope		1 day	No
Secondary	end-tidal pressures of carbon dioxide (PET CO2)		1 day	No
Secondary	Changes in arterial blood parameters		1 day	No