How short-term low oxygen exposure affects the right side of the heart in healthy adults
Effect of Acute Hypoxia on RIght VEntRicular Function. A Single-Center, Double-Blind, Randomized Controlled Cross-Over Trial.
We test whether short-term reduced oxygen (simulated 2,500 m and 4,000 m) changes right ventricular function in healthy adults at rest and during light exercise.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Zurich Academic / other |
| Locations | 2 sites (Zurich, Canton of Zurich and 1 other locations) |
| Trial ID | NCT07431567 on ClinicalTrials.gov |
What this trial studies
Healthy volunteers will undergo randomized, double-blind, cross-over exposure to normobaric hypoxia mimicking altitudes of 490 m, 2,500 m, and 4,000 m while resting and during light cycling. Right ventricular function will be measured noninvasively using speckle-tracking echocardiography, and investigators will also record heart rate, blood pressure, oxygen saturation, blood/gas measures, tissue oxygenation, and symptoms such as shortness of breath and leg fatigue. Each participant acts as their own control by completing all altitude conditions in random order at a single center. The trial enrolls adults 18–80 years who live below 800 m and have not had recent high-altitude exposure, providing reference data for future patient comparisons.
Who should consider this trial
Good fit: Ideal participants are healthy adults aged 18–80 who live below 800 m, have not been exposed to >2,500 m for more than 24 hours in the prior three weeks, and can complete light exercise and ultrasound procedures.
Not a fit: People with diagnosed cardiopulmonary disease, recent prolonged high-altitude exposure, pregnancy or lactation, severe comorbid conditions, or inability to follow study procedures are unlikely to benefit from enrolling.
Why it matters
Potential benefit: If successful, the results will provide reference data that help interpret right ventricular responses to low oxygen and guide recommendations for people with heart or lung disease at altitude.
How similar studies have performed: Prior work using echocardiography and hypoxia exposure has characterized some cardiac responses to altitude, but acute effects on the healthy right ventricle during light exercise remain relatively understudied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Signed informed consent * 18-80 years (age group young: 18-39.99 years / age group older: 40-80 years) * All sex and genders -Living \<800m and without altitude exposure \> 2500 m and \> 24h within the last three weeks Exclusion Criteria: * \<18, \>80 years old -Any diagnosed cardiopulmonary condition including past HAPE * Other clinically significant severe concomitant disease states (e.g. renal, hepatic dysfunction, etc.) * Inability to follow the procedures of the study due to language problems, psychological neurological disorders or orthopaedic disorders * Participants permanently living \>800m and altitude exposure \> 2500 m and \>24h within the last three weeks * Pregnancy: Participants will be asked if pregnant or not, no screening for undetected pregnancy * Lactating women -Participation in other study with active treatment
Where this trial is running
Zurich, Canton of Zurich and 1 other locations
- Consultant Clinic of Pulmonology, University Hospital of Zurich — Zurich, Canton of Zurich, Switzerland (Recruiting)
- Consultant Clinic of Pulmonology, University Hospital of Zurich — Zurich, Switzerland (Not_yet_recruiting)
Study contacts
- Principal investigator: Mona Lichtblau — University of Zurich
- Study coordinator: Mona Lichtblau, PD Dr. med.
- Email: mona.lichtblau@usz.ch
- Phone: +41 442552220
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.