Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID07431554

Effect of Acute Hypoxia on Right Ventricular Function A Single-Center, Double-Blind, Randomized Controlled Cross-Over Trial

Led by Mona Lichtblau · Updated on 2026-05-01

18

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating how the heart, especially the right ventricle, reacts to low oxygen levels during short-term exposure to simulated altitudes of 2,500 m and 4,000 m. This study focuses on adults with a history of high-altitude pulmonary edema (HAPE) and aims to understand how right ventricular function changes under these conditions, both at rest and during light exercise. The study uses a randomized, double-blind, cross-over design to explore these effects and improve future support for affected patients. Participants will experience three different simulated altitude conditions: near sea level (490 m), 2,500 m, and 4,000 m above sea level. Each participant breathes a special gas mixture that mimics these altitudes while resting and during low-intensity cycling exercise. The order of these conditions is randomized, with at least a two-hour break between exposures to allow recovery. The study measures heart function using ultrasound and other vital signs throughout each condition. During each study visit, participants undergo a one-hour resting period followed by a 10-minute cycling exercise at low intensity. Researchers measure heart rate, blood pressure, oxygen saturation, lung and brain oxygen levels, and symptoms such as breathlessness and leg fatigue. Blood samples are taken to analyze various markers. The main outcome is how the right ventricle functions during rest and exercise under low oxygen. Participation may last two to three days, scheduled flexibly for each individual.

CONDITIONS

Brief Title

Effect of Acute Hypoxia on RIght VEntRicular Function in HAPE.

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent
  • Diagnosed or suspicion of past high-altitude pulmonary edema (HAPE)
  • Aged 18 to 80 years
  • All sexes and genders
  • Living below 800 meters above sea level
  • No exposure to altitudes above 2,500 meters for more than 24 hours within the last three weeks
Not Eligible

You will not qualify if you...

  • Younger than 18 or older than 80 years
  • Any other diagnosed heart or lung condition
  • Other severe medical conditions such as kidney or liver problems
  • Unable to follow study procedures due to language, psychological, neurological, or orthopedic issues
  • Living permanently above 800 meters or recent high altitude exposure above 2,500 meters for more than 24 hours within three weeks
  • Pregnant or lactating women
  • Participation in another active treatment study

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 day

Participants undergo baseline assessments including heart ultrasound, vital signs, and blood samples to evaluate heart function and oxygenation before exposure to different oxygen levels.

1 visit (in-person)

Monitoring

Duration - 2 to 3 days depending on participant schedule

Participants experience three different oxygen conditions simulating altitudes of 490 m, 2,500 m, and 4,000 m in random order. Each condition includes 1 hour of rest and a 10-minute low-intensity cycling exercise while heart function and oxygen levels are continuously monitored.

Multiple visits over 2 to 3 days with washout periods of at least 2 hours between conditions

Trial Site Locations

Total: 1 location

1

Consultant Clinic of Pulmonology, University Hospital of Zurich

Zurich, Switzerland, 8091

Actively Recruiting

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Research Team

M

Mona Lichtblau, PD Dr. med.

C

Carmen Wick, Cand. PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

DIAGNOSTIC

Number of Arms

6

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