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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

Tracking Information
First Submitted Date  ICMJE May 18, 2014
First Posted Date  ICMJE May 21, 2014
Last Update Posted Date April 24, 2018
Study Start Date  ICMJE May 2014
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02143687 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2014)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Patients With Pulmonary Hypertension or Interstitial Lung Disease at Altitude - Effect of Oxygen on Exercise Performance
Official Title  ICMJE Patients With Pulmonary Hypertension or Interstitial Lung Disease Travelling to Altitude - Effect of Nocturnal Oxygen Therapy on Exercise Performance
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Precapillary Pulmonary Hypertension
  • Interstitial Lung Disease
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Moderate altitude sojourn
    Sojourn at moderate altitude (2048 m)
    Interventions:
    • Behavioral: Moderate altitude sojourn
    • Behavioral: Low altitude sojourn
    • Drug: Oxygen
    • Drug: Sham oxygen (room air)
  • Experimental: Low altitude sojourn
    Sojourn at low altitude (490 m, baseline)
    Interventions:
    • Behavioral: Moderate altitude sojourn
    • Behavioral: Low altitude sojourn
    • Drug: Oxygen
    • Drug: Sham oxygen (room air)
  • Active Comparator: Oxygen
    Oxygen administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m
    Interventions:
    • Behavioral: Moderate altitude sojourn
    • Behavioral: Low altitude sojourn
    • Drug: Oxygen
    • Drug: Sham oxygen (room air)
  • Placebo Comparator: Sham oxygen (room air)
    Sham oxygen (room air) administration via a nasal cannula at a rate of 3 L/min during nights
    Interventions:
    • Behavioral: Moderate altitude sojourn
    • Behavioral: Low altitude sojourn
    • Drug: Oxygen
    • Drug: Sham oxygen (room air)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: May 20, 2014)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02143687
Other Study ID Numbers  ICMJE ID 2013-0088V2A3C
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Zurich
Study Sponsor  ICMJE University of Zurich
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Konrad E Bloch, MD University Hospital, Zürich
PRS Account University of Zurich
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP