Acute Exposure of High Altitude on Cardiac Output

University of Zurich28 enrolled

Overview

Randomized crossover trial in patients with Pulmonary Hypertension (PAH, CTEPH) to assess the acute response High Altitude (Säntis; 2500m above sea level) on non-invasive cardiac output assessments by Finapres® NOVA Technology at rest and under exercise

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 High Altitude (2500m) and Low Altitude (Zurich; 470m) up to 5 hours, the participants cardiac output non-invasively assessed will be measured repetitive during the whole intervention.

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: 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

Locations (1)

Respiratory Clinic, University Hospital of Zurich

Zurich, Switzerland

Outcomes

Primary Outcomes

Cardiac Output measured non-invasively

Change in non-invasive assessed cardiac output measured with a finger cuff (Finapres) during the exposure to High Altitude (2500m) compared to Low Altitude (Zurich; 470m)

Time frame: Averaged over two minutes rest and 30 seconds end of exercise (exhaustion)

Data from ClinicalTrials.gov

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