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Status:

RECRUITING

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

Lead Sponsor:

Insel Gruppe AG, University Hospital Bern

Conditions:

Aortic Stenosis

Altitude

Eligibility:

All Genders

18+ years

Phase:

NA

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 ...

Detailed Description

\- Hemodynamic changes of high altitude exposure Atmospheric pressure exponentially decreases with increasing altitude and results in hypobaric hypoxia and arterial hypoxemia. Adaptive mechanisms to ...

Eligibility Criteria

Inclusion

  • 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

  • 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)

Key Trial Info

Start Date :

April 1 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

September 1 2026

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT06894550

Start Date

April 1 2025

End Date

September 1 2026

Last Update

March 25 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

University Hospital Inselspital, Bern

Bern, Switzerland, CH-3010