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Acute Exposure of Simulated Hypoxia on Pulmonary Artery Pressure and Right Heart Function (Echo)

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)

About this trial

This is an interventional prevention trial for Pulmonary Hypertension focused on measuring Simulated altitude, Pulmonary artery pressure, Echocardiography, Right heart function

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

Arm Label

Order air-hypoxia

Order hypoxia-air

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Echocardiographic assessment under hypoxia (FiO2: 15.1)

Pulmonary artery pressure measured by echo (TTE)

Secondary Outcome Measures

Echocardiographic assessment of the right heart under hypoxia (FiO2: 15.1)

Right heart functions measured by echo (TTE) (fac, d-shaping, kinetic etc.)

Full Information

NCT ID

NCT03637088

First Posted

July 9, 2018

Last Updated

August 12, 2019

Sponsor

University of Zurich

1. Study Identification

Unique Protocol Identification Number

NCT03637088

Brief Title

Acute Exposure of Simulated Hypoxia on Pulmonary Artery Pressure and Right Heart Function (Echo)

Official Title

Acute Exposure to Hypoxia in Precapillary Pulmonary Hypertension: Physiological and Clinical Effects at Rest and During Exercise

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Completed

Study Start Date

August 1, 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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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 pulmonary artery pressure and right heart function (Echo).

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. Several times within the exposure, the pulmonary artery pressure and the right heart function will be assessed by echo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Hypertension

Keywords

Simulated altitude, Pulmonary artery pressure, Echocardiography, Right heart function

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 through a facemask during both interventions.

Allocation

Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Order air-hypoxia

Arm Type

Experimental

Arm Description

Arm Title

Order hypoxia-air

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Simulated Altitude (FiO2: 15.1%)

Intervention Description

Inhalation of deoxygenated air through a altitude simulator ("Altitrainer"), for approx. 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

Echocardiographic assessment under hypoxia (FiO2: 15.1)

Description

Pulmonary artery pressure measured by echo (TTE)

Time Frame

2 hours

Secondary Outcome Measure Information:

Title

Echocardiographic assessment of the right heart under hypoxia (FiO2: 15.1)

Description

Right heart functions measured by echo (TTE) (fac, d-shaping, kinetic etc.)

Time Frame

2 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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, Prof.

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 Pulmonary Artery Pressure and Right Heart Function (Echo)

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