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RECRUITING

NCT06894550

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

Sponsor: Insel Gruppe AG, University Hospital Bern

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-04-01

Completion Date

2026-09-01

Last Updated

2025-03-25

Healthy Volunteers

Yes

Conditions

Aortic Stenosis Altitude

Interventions

BEHAVIORAL

Participants 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)

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)

Locations (1)

University Hospital Inselspital, Bern

Bern, Switzerland