NCT03592979

Acute Exposure of Simulated Hypoxia on Heart Rate and Ventilation During Exercise

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: University of Zurich · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 heart rate and Ventilation changes under exercise.

Detailed description

Low altitude baseline measurements will be performed in Zurich (469m asl) including Echocardiography, right heart catheterization, six-minute walk 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 be 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' heart rate and Ventilation will be compared under exercise.

Conditions

• Pulmonary Hypertension

Interventions

Type	Name	Description
DEVICE	Simulated Altitude: (FiO2: 15.1)	Inhalation of deoxygenated air through an altitude simulator ("Altitrainer") for approximately 1 hour given by a facemask.
DEVICE	Shamed Hypoxia (FiO2: 20.9)	Inhalation of unmodified air through an altitude simulator ("Altitrainer") for approximately 1 hour given by a facemask.

Timeline

• Start date: 2018-07-01
• Primary completion: 2019-04-01
• Completion: 2019-04-01
• First posted: 2018-07-19
• Last updated: 2020-01-07

Locations

1 site across 1 country: Switzerland