Active — Not RecruitingNot Applicable

Adaptation of Lung Transplant Recipients at Extreme Altitude

Austria30 participantsStarted 2026-01-10

Plain-language summary

This prospective observational study investigates the effects of intermittent hypoxic conditioning and real high-altitude exposure in lung transplant recipients compared with healthy controls. The study includes an eight-week home-based preparatory phase during which participants use a normobaric hypoxic tent with reduced oxygen concentration. Prior to this phase, all participants receive standardized training on the safe use of the equipment. During the preparatory period, daily vital parameters, including heart rate, oxygen saturation, and heart rate variability, are recorded using a sports watch and a pulse oximeter. Symptoms, adverse events, and subjective well-being are documented daily in an electronic diary. All data are transmitted to the study team via encrypted electronic systems, allowing continuous remote monitoring. At the end of the preparatory phase, participants undergo a clinical evaluation to confirm fitness for the expedition phase. The expedition phase consists of a monitored ascent of Aconcagua (6,971 meters). Before departure, all participants are required to attend a comprehensive safety, protection, and first aid training conducted jointly by the study team and professional expedition providers. The expedition is planned and led by an experienced international expedition company in cooperation with a local provider specializing in high-altitude mountaineering. The expedition includes arrival in Mendoza, preparatory procedures such as equipment checks and permits, followed by a staged ascent to base camp. Subsequent days involve rest periods and acclimatization hikes with the establishment of progressively higher camps. A summit attempt is planned after sufficient acclimatization, followed by descent to high camp. A weather-dependent buffer period is included before the final descent to the valley and return to Mendoza, where the expedition concludes. Total study participation is expected to last approximately 15 weeks, including about eight weeks of home-based preparation and approximately three weeks at altitude. A final follow-up examination is conducted 2 to 4 weeks after completion of the expedition, marking the end of study participation.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Lung transplant recipients: * Age ≥ 18 years * \> 1 years after lung transplantation * Stable lung function over 6 month prior to inclusion, FEV1 +/-10% from baseline * VO2peak of more than 25 ml/min/kg * Physical and mental fitness, defined as the ability to complete strenuous day trips lasting 8 to 10 hours independently without suffering from a fear of heights, an altitude exposure of at least 2500m must be confirmed. * Negative pregnancy test for women of childbearing age * Written informed consent Healthy volunteers: * Age ≥ 18 years * VO2peak of more than 25 ml/min/kg * Physical and mental fitness, defined as the ability to complete strenuous day trips lasting 8 to 10 hours independently without suffering from a fear of heights * Negative pregnancy test for women of childbearing age * Written informed consent Exclusion Criteria: Lung transplant recipients: * Age \< 18 years * Refusal to participate in the study * Pregnancy Healthy controls: * Age \< 18 years * Refusal to participate in the study * Pregnancy * Chronic obstructive pulmonary disease (COPD)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in forced expiratory volume in one second (FEV₁)

Timeframe: From enrollment to the end of the expedition at 3 weeks

Change in peripheral oxygen saturation (SpO₂) as a marker of physiological adaptation

Timeframe: From enrollment to the end of the expedition at 3 weeks

Trial details

NCT IDNCT07479511

SponsorMedical University of Vienna

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-05-30

View on ClinicalTrials.gov More Lung Transplantation trials