- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03574675
Acute Exposure of Simulated Hypoxia on Cardiac Output
Acute Exposure of Simulated Hypoxia on Non-invasive Cardiac Output Assessments at Rest and During Exercise
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Low altitude baseline measurements will be performed in Zurich (470m asl) including Echocardiography, right heart catheterization, six-minute walk test (6MWT), pulmonary function test, clinical assessment and blood gas analysis at rest and under exercise.
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.
During the exposure to simulated altitude (FiO2: 15.1%) and shamed altitude of 1 hour each, the participants cardiac output non-invasively assessed will be measured throughout the whole intervention.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Zurich, Switzerland, 8091
- Respiratory Clinic, University Hospital of Zurich
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Informed consent
- PH diagnosed according to internation Guidelines: mean pulmonary artery pressure (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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Order Sham/Hypoxia
The participants will be consecutively exposed to shamed hypoxia (FiO2: 20.9%) equivalent to sea level and to simulated altitude (FiO2: 15.1%) equivalent to 2500m above sea level administered by an altitude simulator ("Altitrainer", SMTEC) with a facemask.
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Inhalation of unmodified air through an altitude simulator ("Altitrainer") for approximately 1 hour given by a facemask.
Inhalation of deoxygenated air through an altitude simulator ("Altitrainer") for approximately 1 hour given by a facemask.
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Experimental: Order Hypoxia/Sham
The participants will be consecutively exposed to hypoxia (FiO2: 15,1%) equivalent to 2500m above sea level and to shamed hypoxia (FiO2: 20.9%) equivalent to sea level administered by an altitude simulated ("Altitrainer", SMTEC) with a facemask.
|
Inhalation of unmodified air through an altitude simulator ("Altitrainer") for approximately 1 hour given by a facemask.
Inhalation of deoxygenated air through an altitude simulator ("Altitrainer") for approximately 1 hour given by a facemask.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cardiac Output measured non-invasively
Time Frame: 1 hour
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Change in non-invasive assessed cardiac output measured with a finger cuff (Finapres) during the exposure to simulated altitude (FiO2: 15.1%) compared to normoxia
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1 hour
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-00455_A6
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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