NCT03637140

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) under exercise.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2018

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

July 9, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 17, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

January 7, 2020

Status Verified

January 1, 2020

Enrollment Period

9 months

First QC Date

July 9, 2018

Last Update Submit

January 6, 2020

Conditions

Pulmonary Hypertension

Keywords

Simulated altitudePulmonary artery pressureEchocardiographyRight heart functionexercise

Outcome Measures

Primary Outcomes (1)

  • Echocardiographic Assessment under hypoxia during exercise

    Pulmonary artery pressure assessed under exercise by echo (TTE)

    1 day at altitude

Secondary Outcomes (1)

  • Echocardiographic right heart functions under hypoxia during exercise

    1 day at altitude

Study Arms (2)

Order A

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 B

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 AOrder B
Shamed Hypoxia (FiO2: 20.9)DEVICE

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

Order AOrder B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Respiratory Clinic, University Hospital of Zurich

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Hypertension, PulmonaryMotor Activity

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular DiseasesBehavior

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
Model Details: Including a baseline assessment and assessments under simulated altitude and normoxia.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2018

First Posted

August 17, 2018

Study Start

July 1, 2018

Primary Completion

April 1, 2019

Study Completion

April 1, 2019

Last Updated

January 7, 2020

Record last verified: 2020-01

Locations

CH(1)