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Completed

NCT Number: NCT03637218

Acute Exposure of High Altitude on Cardiac Output

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

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Key information

Conditions

Pulmonary Hypertension Altitude Sickness Cardiovascular Diseases Hypertension Hypertension, Pulmonary Lung Diseases Respiration Disorders Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Respiratory Clinic, University Hospital of Zurich

Zurich, 8091, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Cardiac Output measured non-invasively

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

    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)

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

Acute Exposure of Simulated Hypoxia on Non-invasive Cardiac Output Assessments at Rest and During Exercise

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 17, 2018
Registry last updated
Jan 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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