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

University of Zurich (UZH)

Status and phase: Completed; Phase 2

Conditions: Chronic Cardiorespiratory Disease; Pulmonary Arterial and Chronic Thromboembolic Pulmonary Hypertension

Treatments: Procedure: Supplemental oxygen via a mask

Study type: Interventional

Funder types: Other

Identifiers

NCT01748474

KEK-ZH-NR. 2012-0251

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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20 participants in 2 patient groups, including a placebo group

Supplemental oxygen

Experimental group

Description:

Supplemental oxygen will be applied via a mask during CPET

Treatment:

Procedure: Supplemental oxygen via a mask

Sham room air

Placebo Comparator group

Description:

Room air will be applied similarly to oxygen

Treatment:

Procedure: Supplemental oxygen via a mask