NCT02143687

Patients With Pulmonary Hypertension or Interstitial Lung Disease at Altitude - Effect of Oxygen on Exercise Performance

Patients With Pulmonary Hypertension or Interstitial Lung Disease Travelling to Altitude - Effect of Nocturnal Oxygen Therapy on Exercise Performance

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Zurich · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the effect of travelling to moderate altitude and of nocturnal oxygen therapy during a stay at moderate altitude on exercise performance of patients with pulmonary hypertension or with interstitial lung disease.

Detailed description

Patients with pulmonary hypertension or with interstitial lung disease living below 800 m will be invited to participate in a randomized, cross-over field trial evaluating the hypotheses that: a), exercise capacity during a 2 day sojourn at moderate altitude is reduced in comparison to low altitude; b), exercise capacity during a 2 day sojourn at moderate altitude is improved by nocturnal oxygen therapy compared to room air (sham oxygen) administered during nights at altitude. Outcomes will be assessed at low altitude (Zurich, 490 m, baseline), and during 2 study periods of 2 days each spent at moderate altitude (St. Moritz Salastrains, 2048 m), separated by a wash-out period of at least 2 weeks spent at low altitude (\<800 m). The order of stays at the different altitudes and of the treatments will be randomized.

Conditions

• Precapillary Pulmonary Hypertension
• Interstitial Lung Disease

Interventions

Type	Name	Description
BEHAVIORAL	Moderate altitude sojourn	Participants will travel from Zurich (490 m) to St. Moritz Salastrains (2048 m) and stay there for 2 days
BEHAVIORAL	Low altitude sojourn	Low altitude baseline evaluations will be performed during a stay at Zurich (490)
DRUG	Oxygen	Oxygen administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m
DRUG	Sham oxygen (room air)	Sham oxygen (room air) administration via a nasal cannula at a rate of 3 L/min during nights at 490 m and 2048 m

Timeline

• Start date: 2014-05-01
• Primary completion: 2021-10-01
• Completion: 2021-10-01
• First posted: 2014-05-21
• Last updated: 2021-10-07

Locations

1 site across 1 country: Switzerland