Short-term Exposure to High Altitude in Patients With Asymptomatic Aortic Stenosis (NCT06894550) | Clinical Trial Compass
CompletedNot Applicable
Short-term Exposure to High Altitude in Patients With Asymptomatic Aortic Stenosis
Switzerland41 participantsStarted 2025-03-01
Plain-language summary
Aortic stenosis is a common disease with increasing prevalence due to an aging population. Aortic valve replacement is indicated for symptomatic severe aortic stenosis. Leisure activities and tourism at high altitude destinations are popular but may impose a higher risk to patients with aortic stenosis. Pathophysiological considerations led to an expert consensus to avoid high altitude exposure, though there is no robust scientific evidence.
Hence, the objective of this study is to evaluate the safety of high altitude exposure in patients with asymptomatic moderate or severe aortic stenosis by the measurement of surrogate markers for cardiac adverse events such as the decrease in exercise capacity, the assessment of changes in cardiac filling pressures, cardiac dimensions and function, and the evaluation of the incidence of cardiac arrhythmia.
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:
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 classificatio…
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
1
Safety of high altitude exposure in patients with asymptomatic moderate or severe aortic stenosis. Spiroergometry outcome 1
Timeframe: At end of the investigation at 3545m above sea level, expected to be on average after 3-4 hours
2
Safety of high altitude exposure in patients with asymptomatic moderate or severe aortic stenosis. Spiroergometry outcome 2
Timeframe: At end of the investigation at 3545m above sea level, expected to be on average after 3-4 hours
3
Safety of high altitude exposure in patients with asymptomatic moderate or severe aortic stenosis. Echocardiography outcome 1
Timeframe: At end of the investigation at 3545m above sea level, expected to be on average after 3-4 hours
4
Safety of high altitude exposure in patients with asymptomatic moderate or severe aortic stenosis. Echocardiography outcome 2
Timeframe: At end of the investigation at 3545m above sea level, expected to be on average after 3-4 hours
5
Safety of high altitude exposure in patients with asymptomatic moderate or severe aortic stenosis. Rhythmologic outcome
Timeframe: At end of the investigation at 3545m above sea level, expected to be on average after 3-4 hours