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Acute Exposure to Simulated Hypoxia on Exercise Capacity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03592927
Recruitment Status : Completed
First Posted : July 19, 2018
Last Update Posted : August 16, 2019
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Brief Summary:
Randomized crossover trial in patients with Pulmonary Hypertension (PAH, CTEPH) to assess the acute response to simulated altitude (FiO2:15.1, equivalent to 2500m above sea level) in constant loaded exercise capacity.

Condition or disease Intervention/treatment Phase
Pulmonary Hypertension Device: Simulated Altitude (FiO2: 15.1%) Device: Shamed Hypoxia (FiO2: 20.9) Not Applicable

Detailed Description:

Low altitude baseline measurements will be performed in Zurich (460m asl) including Echocardiography, Right heart catheterization, six-minute walk test (6MWT), pulmonary function test, clinical assessment and blood gas Analysis.

Randomly assigned to the order of testing, the participants will be tested under simulated altitude (FiO2: 15.1% with the "AMC Altitrainer") and shamed altitude with the same device.

Towards the end of the exposure after approximately 1h, the participants will perform a constant loaded exercise test on an Ergometer with a calculated resistance of their 60% max. workload.

The patients will be encouraged to perform this test up to their physical exhaustion.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Including a baseline assessment and assessments under simulated altitude and normoxia.
Masking: Single (Participant)
Masking Description: The allocated gas mixture will not be disclosed to the patient since he will breath through a facemask during both interventions.
Primary Purpose: Prevention
Official Title: Acute Exposure to Hypoxia in Precapillary Pulmonary Hypertension: Physiological and Clinical Effects at Rest and During Exercise
Actual Study Start Date : August 1, 2018
Actual Primary Completion Date : April 1, 2019
Actual Study Completion Date : April 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Order A
The participants will be exposed to shamed hypoxia (FiO2: 20.9% equivalent to sea level and consecutively to simulated altitude (FiO2: 15.1% equivalent to 2500m above sea level) administered by an altitude Simulator ("Altitrainer", SMTEC), simulated altitude (FiO2: 15.1%), with a facemask.
Device: Simulated Altitude (FiO2: 15.1%)
Inhalation of deoxygenated air through a altitude simulator ("Altitrainer"), for approx. 1 hour. given by a facemask.

Device: Shamed Hypoxia (FiO2: 20.9)
Inhalation of unmodified air through an altitude Simulator ("Altitrainer") for approximately 1 hour given by a facemask

Experimental: Order B
The participant will be exposed to hypoxia (FiO2, 15.1% equivalent to 2500m above sea level), simulated altitude (FiO2: 15.1%), and consecutively to shamed hypoxia (FiO2, 20.9%) administered by an altitude simulator ("Altitrainer", SMTEC) with a facemask.
Device: Simulated Altitude (FiO2: 15.1%)
Inhalation of deoxygenated air through a altitude simulator ("Altitrainer"), for approx. 1 hour. given by a facemask.

Device: Shamed Hypoxia (FiO2: 20.9)
Inhalation of unmodified air through an altitude Simulator ("Altitrainer") for approximately 1 hour given by a facemask




Primary Outcome Measures :
  1. Endurance time under hypoxia (FiO2: 15.1%) [ Time Frame: Towards the end of a one hour exposure ]
    Constant loaded exercise test



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed consent
  • PH diagnosed according to internation Guidelines: mean pulmonary artery presssure (mPAP) ≥ 25 mmHg along with a pulmonary artery wedge pressure (PAWP) ≤15 mmHg during right heart catheterization at the time of initial diagnosis
  • PH class 1 (PAH) or 4 (CTEPH)
  • Stable condition, on the same medication for > 4 weeks
  • Patient live permanently at an altitude < 1000m asl.

Exclusion Criteria:

  • Resting partial Oxygen pressure (PaO2) ≤7.3 kiloPascal (kPA) corresponding to the requirement of long-term oxygen therapy > 16hour daily (nocturnal oxygen therapy alone is allowed)
  • Severe daytime hypercapnia (pCO2 > 6.5 kPa)
  • Susceptibility to high altitude related diseases (AMS, High Altitude Pulmonary edema (HAPE), etc.) based on previous experienced discomfort at altitudes.
  • Exposure to an altitude >1500m for ≥3 nights during the last 4 weeks before the study participation
  • Residence > 1000m above sea level
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, neurological or orthopedic problems with walking disability
  • Women who are pregnant or breast feeding

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): NCT03592927


Locations
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Switzerland
Respiratory Clinic, University Hospital of Zurich
Zurich, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
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Principal Investigator: Silvia Ulrich, Prof. University of Zurich

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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT03592927    
Other Study ID Numbers: 2018-00455_A1
First Posted: July 19, 2018    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Zurich:
exercise capacity
simulated altitude
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Hypoxia
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms