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Acute Exposure of Simulated Hypoxia on Cardiac Output

Primary Purpose

Pulmonary Hypertension

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Simulated Altitude (FiO2: 15.1)
Shamed Hypoxia (FiO2: 20.9)
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pulmonary Hypertension focused on measuring simulated altitude, exercise, non-invasive cardiac output

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Respiratory Clinic, University Hospital of Zurich

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Order Sham/Hypoxia

Order Hypoxia/Sham

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Cardiac Output measured non-invasively
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

Secondary Outcome Measures

Full Information

First Posted
June 20, 2018
Last Updated
January 6, 2020
Sponsor
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT03574675
Brief Title
Acute Exposure of Simulated Hypoxia on Cardiac Output
Official Title
Acute Exposure of Simulated Hypoxia on Non-invasive Cardiac Output Assessments at Rest and During Exercise
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
May 2, 2018 (Actual)
Primary Completion Date
April 1, 2019 (Actual)
Study Completion Date
April 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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) on non-invasive cardiac output assessments by Finapres® "NOVA" Technology at rest and under exercise.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension
Keywords
simulated altitude, exercise, non-invasive cardiac output

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Including a baseline assessment and assessments under simulated altitude and normoxia
Masking
Participant
Masking Description
The allocated gas mixture will not be disclosed to the patient since he will breath trough a facemask during both interventions.
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Order Sham/Hypoxia
Arm Type
Experimental
Arm Description
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.
Arm Title
Order Hypoxia/Sham
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Simulated Altitude (FiO2: 15.1)
Intervention Description
Inhalation of deoxygenated air through an altitude simulator ("Altitrainer") for approximately 1 hour given by a facemask.
Intervention Type
Device
Intervention Name(s)
Shamed Hypoxia (FiO2: 20.9)
Intervention Description
Inhalation of unmodified air through an altitude simulator ("Altitrainer") for approximately 1 hour given by a facemask.
Primary Outcome Measure Information:
Title
Cardiac Output measured non-invasively
Description
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
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Silvia Ulrich, MD
Organizational Affiliation
University of Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Respiratory Clinic, University Hospital of Zurich
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

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Acute Exposure of Simulated Hypoxia on Cardiac Output

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