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

NCT03637088 | Completed

• 1 other identifier: 2018-00455_A2
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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).

Conditions

Pulmonary Hypertension

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Echocardiographic assessment under hypoxia (FiO2: 15.1)

  Pulmonary artery pressure measured by echo (TTE)

  2 hours

Secondary Outcomes (1)

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

  2 hours

Study Arms (2)

Order air-hypoxia

EXPERIMENTAL

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%); Device: Shamed Hypoxia (FiO2: 20.9)

Order hypoxia-air

EXPERIMENTAL

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%); Device: Shamed Hypoxia (FiO2: 20.9)

Interventions

Simulated Altitude (FiO2: 15.1%) DEVICE

Inhalation of deoxygenated air through a altitude simulator ("Altitrainer"), for approx. 1 hour. given by a facemask.

Order air-hypoxia; Order hypoxia-air

Shamed Hypoxia (FiO2: 20.9) DEVICE

Inhalation of unmodified air through an altitude simulator ("Altitrainer") for approximately 1 hour given by a facemask

Order air-hypoxia; Order hypoxia-air

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Respiratory Clinic, University Hospital of Zurich

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Silvia Ulrich, Prof.

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The allocated gas mixture will not be disclosed to the patient since he will breath through a facemask during both interventions.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Including a baseline assessment and assessments under simulated altitude and normoxia.

Study Record Dates

• First Submitted: July 9, 2018
• First Posted: August 17, 2018
• Study Start: August 1, 2018
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: August 13, 2019

Record last verified: 2019-08

Locations

CH (1)