Clinical trial NCT02143687: Patients With Pulmonary Hypertension or Interstitial Lung Disease at Altitude - Effect of Oxygen on Exercise Performance
Official title: Patients With Pulmonary Hypertension or Interstitial Lung Disease Travelling to Altitude - Effect of Nocturnal Oxygen Therapy on Exercise Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Precapillary Pulmonary Hypertension
Interstitial Lung Disease
Keywords: Pulmonary hypertension
Interstitial lung disease
Pulmonary fibrosis
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2014-05-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Precapillary pulmonary hypertension, or interstitial lung disease.
* New York Heart Association class 2-3.
* Residence at low altitude (\<800m).

Exclusion Criteria:

* Unstable or exacerbated condition
* Very severe pulmonary hypertension or interstitial lung disease, New York Heart Association class 4
* Requirement for oxygen therapy at low altitude residence
* Hypoventilation
* More than mild or unstable cardiovascular disease
* Use of drugs that affect respiratory center drive
* Internal, neurologic or psychiatric disease that interfere with protocol compliance including current heavy smoking (\>20 cigarettes per day), inability to perform 6 min walk test.
* Previous intolerance to moderate altitude (\<2600m).
* Exposure to altitudes \>1500m for \>2 days within the last 4 weeks before the study.
* Pregnant or nursing patients

Primary outcomes:
measure: 6 min walk distance
timeFrame: Day 2 at 2048 m
Secondary outcomes:
measure: 6 min walk distance
timeFrame: day 3 at 2048 m
measure: Arterial blood gas analysis
timeFrame: Day 2 at 2048 m
measure: Spirometry
timeFrame: Day 2 at 2048 m
measure: Perceived exertion
timeFrame: Day 2 at 2048 m
measure: Perceived exertion
timeFrame: Day 3 at 2048 m
measure: Severe hypoxemia
timeFrame: Day 1 to 3 at 2048 m
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Pulmonary Division
Study officials:
affiliation: University Hospital, Zürich
name: Konrad E Bloch, MD
role: STUDY_CHAIR
References: