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

Interstitial Lung Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02143687
• Other study ID #: ID 2013-0088V2A3C
• Status: Completed
• Phase: Phase 4
• Start date: May 2014
• Est. completion date: October 2021

Study information

• Verified date: October 2021
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2021
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial
• Precapillary Pulmonary Hypertension

Intervention

Behavioral:
• Moderate altitude sojourn
Participants will travel from Zurich (490 m) to St. Moritz Salastrains (2048 m) and stay there for 2 days
• 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
• 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

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Pulmonary Division	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6 min walk distance	Difference in the distance walked in 6 min between measurements at 2048 m (altitude) and 490 m (baseline); and between the oxygen and sham oxygen treatment periods at 2028 m.	Day 2 at 2048 m
Secondary	6 min walk distance	Difference in the distance walked in 6 min between measurements at 2048 m (altitude) and 490 m (baseline); and between the oxygen and sham oxygen treatment periods at 2028 m.	day 3 at 2048 m
Secondary	Arterial blood gas analysis	Change in arterial oxygen partial pressure, carbon dioxide partial pressure, and pH between measurements at 2048 m (altitude) and 490 m (baseline); and between the oxygen and sham oxygen treatment periods at 2028 m.	Day 2 at 2048 m
Secondary	Spirometry	Difference in spirometry between measurements at 2048 m (altitude) and 490 m (baseline); and between the oxygen and sham oxygen treatment periods at 2028 m.	Day 2 at 2048 m
Secondary	Perceived exertion	Difference in the perceived exertion rated with the BORG CR10 scale at the end of the 6 min walk between measurements at 2048 m (altitude) and 490 m (baseline); and between the oxygen and sham oxygen treatment periods at 2028 m.	Day 2 at 2048 m
Secondary	Perceived exertion	Difference in the perceived exertion rated with the BORG CR10 scale at the end of the 6 min walk between measurements at 2048 m (altitude) and 490 m (baseline); and between the oxygen and sham oxygen treatment periods at 2028 m.	Day 3 at 2048 m
Secondary	Severe hypoxemia	Number of participants in whom arterial oxygen saturation measured by pulse oximetry is less than 75% for more than 30 min during the sojourn at 2048 m (altitude) and 490 m (baseline); and during the oxygen and sham oxygen treatment periods at 2028 m.	Day 1 to 3 at 2048 m