Acute Exposure of High Altitude on Cardiac Output

University of Zurich (UZH) logo

University of Zurich (UZH)

Status

Completed

Conditions

Pulmonary Hypertension

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT03637218
2018-00455_B8

Details and patient eligibility

About

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

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 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.

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)

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)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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