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

Pulmonary Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03637140
• Other study ID #: 2018-00455_A8
• Status: Completed
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: April 1, 2019

Study information

• Verified date: January 2020
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 under exercise.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: April 1, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Hypoxia
• Pulmonary Hypertension

Intervention

Device:
• Simulated Altitude (FiO2: 15.1%)
Inhalation of deoxygenated air through a altitude simulator ("Altitrainer"), for approx. 1 hour. given by a facemask.
• Shamed Hypoxia (FiO2: 20.9)
Inhalation of unmodified air through an altitude simulator ("Altitrainer") for approximately 1 hour given by a facemask

Locations

Country	Name	City	State
Switzerland	Respiratory Clinic, University Hospital of Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Echocardiographic Assessment under hypoxia during exercise	Pulmonary artery pressure assessed under exercise by echo (TTE)	1 day at altitude
Secondary	Echocardiographic right heart functions under hypoxia during exercise	Right heart function (fac, D-Shaping, Cardiac Output) assessed by echocardiography under exercise	1 day at altitude