Mountain air or heart risk? trial asks if high altitude is safe for aortic stenosis patients.

NCT ID NCT06894550

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

41 people

The number who actually took part.

Started

Mar 2025

Finished

Jul 2026

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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

  • University Hospital Inselspital, Bern

    Bern, Canton of Bern, CH-3010, Switzerland

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