Effect of Long-term Oxygen Therapy on Exercise Capacity and Quality of Life in Patients With Pulmonary Arterial and Chronic Thromboembolic Pulmonary Hypertension

University of Zurich (UZH)

Status and phase: Completed; Phase 3

Conditions: Pulmonary Arterial and Chronic Thromboembolic Pulmonary Hypertension

Treatments: Procedure: long term oxygen therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01884012

KEK 2012-0538

Details and patient eligibility

About

In this randomized-controlled, cross-over trial the investigators test the effect of long-term oxygen therapy (> 16h/day) given for 5 weeks with a wash-out period between phases of 2 weeks on exercise performance and quality of life and many physiological parameters in patients with pulmonary arterial and chronic thromboembolic pulmonary hypertension.

Enrollment: 30 patients

Sex: All

Ages: 16 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients with established diagnosis of pulmonary arterial or chronic thromboembolic pulmonary 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 weeks, who desaturate in the 6 minute walking test by =4% to values <92%.

Exclusion criteria

• Patients in unstable conditions requiring frequent therapeutic adaption
• pregnant women
• patients with pulmonary venous hypertension due to left heart diseases
• patients with relevant concomitant lung disease and severe daytime hypoxemia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups

Supplemental oxygen

Experimental group

Description:

Supplemental oxygen 3 liters/minute given via a nasal cannula for 16 hours a day

Treatment:

Procedure: long term oxygen therapy

Sham room air

Sham Comparator group

Description:

Room air given at a flow rate of 3 liters per minute for 16 hours a day

Treatment:

Procedure: long term oxygen therapy