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) logo

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

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

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems