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Acute Exposure of Simulated Hypoxia on ECG and Non-invasive Blood Pressure

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, exercise, electrocardiography, non- invasive blood pressure

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 O2 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 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

Non-invasive blood pressure (Finapres)

Change in non-invasive bloodpressure (systolic and diastolic) assessed with a finger cuff (Finapres) during the exposure to simulated altitude (FiO2: 15.1%) compared to normoxia

Secondary Outcome Measures

Electrocardiography

Change in cardiac repolarization during the exposure to simulated altitude (FiO2: 15.1%) compared to normoxia

Full Information

NCT ID

NCT03581851

First Posted

June 20, 2018

Last Updated

January 6, 2020

Sponsor

University of Zurich

1. Study Identification

Unique Protocol Identification Number

NCT03581851

Brief Title

Acute Exposure of Simulated Hypoxia on ECG and Non-invasive Blood Pressure

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

January 2020

Overall Recruitment Status

Completed

Study Start Date

July 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 ECG repolarizations and non-invasive blood pressure measurements by Finapres® NOVA Technology.

Detailed Description

Low altitude baseline measurements will be performed in Zurich (469m asl) including Echocardiography, right heart catheterization, six Minute Walking 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 e 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' ECG and non-invasively assessed blood pressure by Finapres at rest and under exercise will be collected.

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, electrocardiography, non- invasive blood pressure

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

Arm Title

Order Hypoxia/Sham

Arm Type

Experimental

Arm Description

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

Non-invasive blood pressure (Finapres)

Description

Change in non-invasive bloodpressure (systolic and diastolic) assessed with a finger cuff (Finapres) during the exposure to simulated altitude (FiO2: 15.1%) compared to normoxia

Time Frame

1 hour

Secondary Outcome Measure Information:

Title

Electrocardiography

Description

Change in cardiac repolarization 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

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 O2 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 ECG and Non-invasive Blood Pressure

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