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

Launched by INSEL GRUPPE AG, UNIVERSITY HOSPITAL BERN · Mar 18, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating the safety of short-term exposure to high altitudes for patients with aortic stenosis, a condition where the heart's aortic valve narrows, affecting blood flow. The study aims to see if spending time at higher elevations poses any risks to patients who do not have symptoms. Researchers will look at various factors, such as exercise capacity and heart function, to determine if high altitude could lead to any heart-related problems.

To participate in this study, individuals should be aged 65 or older and meet specific health criteria. Eligible participants include those with moderate to severe aortic stenosis who do not experience symptoms, those who have undergone aortic valve replacement within the past year, and individuals without any heart valve issues. Participants will need to provide written consent and will undergo assessments to monitor their heart health during the trial. This study is important because it addresses a common concern regarding high-altitude activities for patients with heart conditions, and it could help improve guidance for patients who enjoy traveling to mountainous areas.

Gender

ALL

Eligibility criteria

• 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)