Acute Exposure to High Altitude on Pulmonary Artery Pressure and Right Heart Function (Echo)

University of Zurich28 enrolled

Overview

Randomized crossover Trial in patients with Pulmonary Hypertension (PAH, CTEPH) to assess the acute response to High Altitude ("Säntis"; 2500m above sea level) on pulmonary artery pressure and right heart function (echo)

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 in Low Altitude (Zurich, 470m) and at High Altitude (2500m). Several times within the exposure, the pulmonary artery pressure (PAP) and the right heart function will be assessed by echo.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Pulmonary Hypertension

Interventions

Assessment at Low Altitude (470m above sea level)OTHER

Assessment at Low Altitude (in Zurich; 470m above sea level) in order to compare this data with High altitude exposure

Exposure to High Altitude (2500m above sea level)OTHER

Exposure to High Altitude ("Säntis"; 2500m above sea level) for approximately 5 hours

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 kPA corresponding to the requirement of long-term oxygen therapy \> 16hour daily (nocturnal oxygen therapy alone is allowed) * Severe daytime hypercapnia (pCO2 \> 6.5 kilopascal (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

Locations (1)

Respiratory Clinic, University Hospital of Zurich

Zurich, Switzerland

Outcomes

Primary Outcomes

Echocardiographic assessment at High Altitude (2500m above sea level)

Pulmonary artery pressure will be measured by echo (TTE).

Time frame: 1 day at altitude

Secondary Outcomes

Echocardiographic right heart assessment at High Altitude (2500m above sea level)

The right heart function (fac, D-Shaping, etc.) will be assessed by Echocardiography (TTE)

Time frame: 1 day at altitude

Data from ClinicalTrials.gov

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