Short-term Exposure to High Altitude in Patients With Asymptomatic Aortic Stenosis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInsel Gruppe AG, University Hospital Bern

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Participants will be escorted to high altitude and undergo a series of test

Treatment groups

60 Participants
are divided into 3 treatment groups