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

Sponsors

Lead Sponsor: University of Zurich

Source University of Zurich
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.

Overall Status Active, not recruiting
Start Date May 2014
Completion Date December 2020
Primary Completion Date December 2020
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
6 min walk distance Day 2 at 2048 m
Secondary Outcome
Measure Time Frame
6 min walk distance day 3 at 2048 m
Arterial blood gas analysis Day 2 at 2048 m
Spirometry Day 2 at 2048 m
Perceived exertion Day 2 at 2048 m
Perceived exertion Day 3 at 2048 m
Severe hypoxemia Day 1 to 3 at 2048 m
Enrollment 50
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Moderate altitude sojourn

Description: Participants will travel from Zurich (490 m) to St. Moritz Salastrains (2048 m) and stay there for 2 days

Other Name: Moderate altitude sojourn at 2048 m for 2 days

Intervention Type: Behavioral

Intervention Name: Low altitude sojourn

Description: Low altitude baseline evaluations will be performed during a stay at Zurich (490)

Other Name: Low altitude sojourn at 490 m (Zurich) for 1.5 days

Intervention Type: Drug

Intervention Name: Oxygen

Description: Oxygen administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m

Other Name: Nocturnal nasal oxygen administration during stay at 2048 m

Intervention Type: Drug

Intervention Name: Sham oxygen (room air)

Description: Sham oxygen (room air) administration via a nasal cannula at a rate of 3 L/min during nights at 490 m and 2048 m

Other Name: Nocturnal nasal room air administration

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Konrad E Bloch, MD Study Chair University Hospital, Zürich
Location
Facility: University Hospital Zurich, Pulmonary Division
Location Countries

Switzerland

Verification Date

January 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: Moderate altitude sojourn

Type: Experimental

Description: Sojourn at moderate altitude (2048 m)

Label: Low altitude sojourn

Type: Experimental

Description: Sojourn at low altitude (490 m, baseline)

Label: Oxygen

Type: Active Comparator

Description: Oxygen administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m

Label: Sham oxygen (room air)

Type: Placebo Comparator

Description: Sham oxygen (room air) administration via a nasal cannula at a rate of 3 L/min during nights

Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Outcomes Assessor)

Source: ClinicalTrials.gov