RecruitingNot ApplicableNCT06894550

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


Sponsor

Insel Gruppe AG, University Hospital Bern

Enrollment

60 participants

Start Date

Apr 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a behavioral approach called Participants will be escorted to high altitude and undergo a series of test for people with altitude and aortic stenosis. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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

Participants will be escorted to high altitude and undergo the following examination both at 540 and 3545m above sea level: * 12-lead electrocardiogram * Transthoracic echocardiography with measurement of left and right ventricular dimension and function, global longitudinal strain and transvalvular gradient * Symptom-limited cardiopulmonary stress exercise test with a ramp protocol with a focused echocardiography for the assessment of cardiac output and transvalvular gradient and blood gas analysis * 24 hours wearable rhythm monitoring * Blood Work: cardiac biomarkers (Troponin T, CK, CK-MB, NT-pro-BNP), blood gas analysis, Hemoglobin, Hematocrit, Leucocytes, Thrombocytes, Creatinin, eGFR, Sodium, Potassium, ASAT, ALAT, Bilirubin)


Locations(1)

University Hospital Inselspital, Bern

Bern, Switzerland

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NCT06894550


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