Acute Exposure to High Altitude on Heart Rate and Ventilation During Exercise

University of Zurich (UZH)

Status: Completed

Conditions: Pulmonary Hypertension

Treatments: Other: Exposure to High Altitude (2500m above sea level); Other: Assessment at Low Altitude (470m above sea level)

Study type: Interventional

Funder types: Other

Identifiers

NCT03593096

2018-00455_B9

Details and patient eligibility

About

Randomized crossover trial in patients with Pulmonary Hypertension (PAH, CTEPH) to assess the acute response to High Altitude (Säntis; 2500m above sea level) on heart rate and Ventilation changes under exercise.

Full description

Low altitude baseline measurements will be performed in Zurich (460m asl) including Echocardiography, Right heart catheterization, 6MWT, pulmonary function test, clinical assessment and blood gas Analysis.

Randomly assigned to the order of testing, the participants will be tested in Low Altitude (Zurich, 470m) and at High Altitude (2500m).

During the exposure to High Altitude (2500m) and Low Altitude (Zurich; 470m) of up to 5 hours, the participants' heart rate and Ventilation will be compared under exercise.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Informed consent
• PH diagnosed according to internation Guidelines: mPAP ≥ 25 mmHg along with a 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 PaO2 ≤7.3 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, 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Order A

Experimental group

Description:

The participants will be tested in Zurich (Low altitude: 470m above sea level) and consecutively at High Altitude(Säntis; 2500m above sea Level)

Treatment:

Other: Exposure to High Altitude (2500m above sea level)

Other: Assessment at Low Altitude (470m above sea level)

Order B

Experimental group

Description:

The participants will be tested at High Altitude (Säntis; 2500m above sea level) and consecutively in Zurich (Low altitude; 470m above sea level).

Treatment:

Other: Exposure to High Altitude (2500m above sea level)

Other: Assessment at Low Altitude (470m above sea level)