Exercise Endurance Time on the 2nd Day at 2500 m High Altitude

University of Zurich (UZH)

Status: Completed

Conditions: High Altitude Pulmonary Hypertension

Treatments: Procedure: Low altitude exposure; Procedure: High altitude exposure

Study type: Interventional

Funder types: Other

Identifiers

NCT05131737

OVERALP II C

Details and patient eligibility

About

The impact of a sojourn at 2500 m of high altitude for 26-30 h on constant work-rate exercise test time in patients with precapillary pulmonary hypertension

Full description

Patients with pulmonary hypertension will perform a constant work-rate exercise test at low altitude (450m) and at high altitude 2500m in a randomized-cross-over sequence protocol. The constant work-rate exercise test time and other measures will be assessed

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Informed consent as documented by signature
• PH class I (PAH) or IV (CTEPH) diagnosed according to guidelines: mean pulmonary artery pressure >20 mmHg, pulmonary vascular resistance ≥3 wood units, pulmonary arterial wedge pressure ≤15 mmHg during baseline measures at the diagnostic right-heart catheterization

Exclusion criteria

• resting partial pressure of oxygen <8 kilopascal at Zurich at 490 m low altitude
• exposure to an altitude >1000 m for ≥3 nights during the last 2 weeks before the study
• inability to follow the procedures of the study
• other clinically significant concomitant end-stage disease (e.g., renal failure, hepatic dysfunction)

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Constant work-rate at altitude 2500 m above sea level (high altitude)

Experimental group

Description:

Cycling at high altitude

Treatment:

Procedure: Low altitude exposure

Procedure: High altitude exposure

Constant work-rate at altitude 470 m above sea level (low altitude)

Active Comparator group

Description:

Cycling at low altitude

Treatment:

Procedure: Low altitude exposure

Procedure: High altitude exposure