Right-heart response to short-term low oxygen in people with past HAPE
Effect of Acute Hypoxia on RIght VEntRicular Function. A Single-Center, Double-Blind, Randomized Controlled Cross-Over Trial.
This trial tests whether brief exposure to simulated high altitude (low oxygen) changes right-heart function in adults who previously had high-altitude pulmonary edema (HAPE).
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 | 1 site (Zurich) |
| Trial ID | NCT07431554 on ClinicalTrials.gov |
What this trial studies
Adults with past HAPE will be exposed, in random order, to three simulated oxygen levels corresponding roughly to 490 m, 2,500 m and 4,000 m both at rest and during light cycling exercise using a controlled gas mixture. The trial uses a randomized, double-blind, cross-over design so each participant experiences all conditions without knowing which is being simulated. Right ventricular function will be measured noninvasively with speckle-tracking echocardiography, and investigators will also record heart rate, blood pressure, blood gases, tissue oxygenation and symptoms such as shortness of breath. The study is single-center and focuses on acute (short-term) physiologic responses rather than long-term outcomes.
Who should consider this trial
Good fit: Adults aged 18–80 with confirmed or suspected past HAPE who live below 800 m and have not had recent exposure above 2,500 m within the prior three weeks are ideal candidates.
Not a fit: People with other diagnosed cardiopulmonary disease, pregnancy or lactation, permanent residence above 800 m, recent high-altitude exposure, or inability to complete study procedures are not eligible and are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the results could help identify who with past HAPE is at risk for right-heart strain at altitude and inform safer guidance for mountain activities.
How similar studies have performed: Previous research has shown acute right-ventricular changes during simulated hypoxia and used speckle-tracking echocardiography, but applying these methods specifically to people with past HAPE is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Signed informed consent * Diagnosed or suspicion of past HAPE * 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 other diagnosed cardiopulmonary condition * 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
- Consultant Clinic of Pulmonology, University Hospital of Zurich — Zurich, Switzerland (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.