Actively Recruiting
Short-term Exposure to High Altitude in Patients With Asymptomatic Aortic Stenosis
Led by Insel Gruppe AG, University Hospital Bern · Updated on 2025-03-25
60
Participants Needed
1
Research Sites
74 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Short-term Exposure to High Altitude in Patients With Asymptomatic Aortic Stenosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Moderate or severe aortic stenosis (aortic valve area 1.5 cm2) with NYHA class I and LVEF > 50%, and aortic stenosis stage 0 or 1
- Aortic valve replacement within 1 year with NYHA class I, LVEF > 50%, and aortic stenosis stage 0 or 1
- No valvular heart disease with NYHA class I, LVEF > 50%, age > 65 years
- Written informed consent
You will not qualify if you...
- NYHA class greater than I
- History of cardiac decompensation requiring hospitalization
- Uncontrolled arterial hypertension (>180/100 mmHg at rest)
- Other cardiomyopathies with normal LVEF (dilated, hypertrophic, infiltrative)
- Exercise-induced ischemia, hemodynamic instability, or ventricular arrhythmias during stress testing
- Chronic obstructive pulmonary disease with FEV1 < 60% of predicted
- Known or suspected pulmonary hypertension with pulmonary artery systolic pressure > 50 mmHg
- NT-pro BNP levels > 900 pg/ml
- Aortic stenosis stage greater than 1 (for groups 1 and 2)
- History of advanced acute mountain sickness (pulmonary or cerebral edema)
- Transvalvular gradient across aortic valve 60 mmHg, Vmax > 5 m/s or progression > 0.3 m/s/year (group 1)
- Transvalvular gradient > 20 mmHg (group 2)
- Evidence of valvular heart disease or coronary artery disease (group 3)
- History of rhythm disturbances except premature ventricular contractions (group 3)
- Right ventricular dysfunction defined as TAPSE < 17 mm or s'DTI < 9 cm/sec
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University Hospital Inselspital, Bern
Bern, Switzerland, CH-3010
Actively Recruiting
Research Team
T
Thomas Pilgrim, MD, MSc
CONTACT
M
Marius R Bigler, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
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