NCT06894550 Short-term Exposure to High Altitude in Patients With Asymptomatic Aortic Stenosis
| NCT ID | NCT06894550 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Insel Gruppe AG, University Hospital Bern |
| Condition | Aortic Stenosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-04-01 |
| Primary Completion | 2026-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-04-01 with a primary completion date of 2026-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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)
Contact & Investigator
Thomas Pilgrim, MD, MSc
STUDY CHAIR
University Hospital of Bern, Bern, Switzerland
Frequently Asked Questions
Who can join the NCT06894550 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Aortic Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06894550 currently recruiting?
Yes, NCT06894550 is actively recruiting participants. Contact the research team at thomas.pilgrim@insel.ch for enrollment information.
Where is the NCT06894550 trial being conducted?
This trial is being conducted at Bern, Switzerland.
Who is sponsoring the NCT06894550 clinical trial?
NCT06894550 is sponsored by Insel Gruppe AG, University Hospital Bern. The principal investigator is Thomas Pilgrim, MD, MSc at University Hospital of Bern, Bern, Switzerland. The trial plans to enroll 60 participants.