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Completed

NCT Number: NCT02143687

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital Zurich, Pulmonary Division

Zurich, CH-8091, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Moderate altitude sojourn

Behavioral

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

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

Low altitude sojourn

Behavioral

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

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

Oxygen

Drug

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

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

sham oxygen (room air)

Drug

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 names: Nocturnal nasal room air administration

Primary outcomes

  1. 6 min walk distance

    Time frame: Day 2 at 2048 m

    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.

Secondary outcomes

  1. 6 min walk distance

    Time frame: day 3 at 2048 m

    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.

  2. Arterial blood gas analysis

    Time frame: Day 2 at 2048 m

    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.

  3. Spirometry

    Time frame: Day 2 at 2048 m

    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.

  4. Perceived exertion

    Time frame: Day 2 at 2048 m

    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.

  5. Perceived exertion

    Time frame: Day 3 at 2048 m

    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.

  6. Severe hypoxemia

    Time frame: Day 1 to 3 at 2048 m

    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.

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2021
Study completion
2021
First posted
May 21, 2014
Registry last updated
Oct 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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