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

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ClinicalTrials.gov Identifier: NCT02143687
Recruitment Status : Active, not recruiting
First Posted : May 21, 2014
Last Update Posted : April 24, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Precapillary Pulmonary Hypertension Interstitial Lung Disease Behavioral: Moderate altitude sojourn Behavioral: Low altitude sojourn Drug: Oxygen Drug: Sham oxygen (room air) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Patients With Pulmonary Hypertension or Interstitial Lung Disease Travelling to Altitude - Effect of Nocturnal Oxygen Therapy on Exercise Performance
Study Start Date : May 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018


Arm Intervention/treatment
Experimental: Moderate altitude sojourn
Sojourn at moderate altitude (2048 m)
Behavioral: Moderate altitude sojourn
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

Behavioral: Low altitude sojourn
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

Drug: Oxygen
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

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
Other Name: Nocturnal nasal room air administration

Experimental: Low altitude sojourn
Sojourn at low altitude (490 m, baseline)
Behavioral: Moderate altitude sojourn
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

Behavioral: Low altitude sojourn
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

Drug: Oxygen
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

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
Other Name: Nocturnal nasal room air administration

Active Comparator: Oxygen
Oxygen administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m
Behavioral: Moderate altitude sojourn
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

Behavioral: Low altitude sojourn
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

Drug: Oxygen
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

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
Other Name: Nocturnal nasal room air administration

Placebo Comparator: Sham oxygen (room air)
Sham oxygen (room air) administration via a nasal cannula at a rate of 3 L/min during nights
Behavioral: Moderate altitude sojourn
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

Behavioral: Low altitude sojourn
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

Drug: Oxygen
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

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
Other Name: Nocturnal nasal room air administration




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02143687


Locations
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Switzerland
University Hospital Zurich, Pulmonary Division
Zurich, Switzerland, CH-8091
Sponsors and Collaborators
University of Zurich
Investigators
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Study Chair: Konrad E Bloch, MD University Hospital, Zürich

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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02143687     History of Changes
Other Study ID Numbers: ID 2013-0088V2A3C
First Posted: May 21, 2014    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: April 2018

Keywords provided by University of Zurich:
Pulmonary hypertension
Interstitial lung disease
Pulmonary fibrosis

Additional relevant MeSH terms:
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Hypertension
Lung Diseases
Hypertension, Pulmonary
Lung Diseases, Interstitial
Vascular Diseases
Cardiovascular Diseases
Respiratory Tract Diseases
Sevoflurane
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs