Mountain air or heart risk? trial asks if high altitude is safe for aortic stenosis patients.
NCT ID NCT06894550
First seen Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time
Summary
This trial investigates whether a short stay at high altitude (up to 3,545 meters) is safe for people with asymptomatic moderate or severe aortic stenosis. Participants will undergo heart tests—including ECG, echocardiography, and exercise stress tests—both at low altitude and after ascending. The goal is to measure changes in exercise capacity, heart function, and rhythm to see if altitude poses a risk.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- short-term high-altitude exposure (ascending to 3545 m above sea level)
- What this could lead to
- If safe, it could provide evidence to update guidelines, allowing people with aortic stenosis to enjoy high-altitude travel without unnecessary restrictions.
- What could go wrong
- This is a small, early-stage observational study with only 41 participants. It measures surrogate markers, not hard outcomes like heart attacks or death, so results may not be definitive.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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41 people
The number who actually took part.
- Started
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Mar 2025
- Finished
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Jul 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Group 1: * Moderate or severe aortic stenosis (aortic valve area (AVA) ≤1.5 cm2) * NYHA class I * LVEF \> 50% * Aortic stenosis staging classification Stage 0 or 1 * Written informed consent Group 2: * Aortic stenosis s/p aortic valve replacement within 1 year * NYHA class I * LVEF \> 50% * Aortic stenosis staging classification Stage 0 or 1 * Written informed consent Group 3: * NYHA class I * LVEF \>50% * No evidence of valvular heart disease * Age \> 65 years * Written informed consent Exclusion Criteria: * NYHA class \> I (all groups) * History of cardiac decompensation requiring hospitalization (all groups) * Uncontrolled arterial hypertension (\>180/100 mmHg at rest) (all groups) * Other Cardiomyopathies w/ normal LVEF (dilatative, hypertrophic, infiltrative CMP) (all groups) * Signs of exercise-induced ischemia (ST-segment depression \> 2 mV), hemodynamic instability (drop in systolic blood pressure \> 20 mmHg and systolic blood pressure ≤ 100 mmHg), or ventricular arrhythmias (\> 5 beats) during cardiopulmonary stress exercise testing (CPET) at Bern (540 meters) (all groups) * Chronic obstructive pulmonary disease with a forced expiratory volume in 1 second (FEV1) \<60% of the predicted (all groups) * Known pulmonary hypertension with a pulmonary artery systolic pressure \>50 mmHg or high probability of pulmonary hypertension as assessed in TTE (all groups) * NT-pro BNP levels \> 900 pg/ml (all groups) * Aortic stenosis staging classification \> Stage 1 (group 1 and 2) * History of advanced stages of acute mountain sickness defined as high altitude pulmonary (HAPE) or cerebral (HACE) edema (all groups) * Transvalvular gradient across the aortic valve ≥60 mmHg, Vmax \>5 m/s (group 1) * Vmax progression ≥0.3 m/s/year (group 1) * Transvalvular gradient across the aortic valve ≥20 mmHg (group 2) * Evidence of valvular heart disease or coronary artery disease (group 3) * History of rhythm disturbances (other than premature ventricular contraction (PVC) (group 3) * Right ventricular dysfunction, defined as TAPSE \< 17 mm, s'DTI \< 9 cm/sec (all groups)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University Hospital Inselspital, Bern
Bern, Canton of Bern, CH-3010, Switzerland
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