Evaluating the effects of high altitude on patients with aortic stenosis

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

This study tests how short trips to high altitudes affect people with moderate or severe aortic stenosis to see if it impacts their heart function and exercise ability.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Insel Gruppe AG, University Hospital Bern (Academic / other)
• Locations: 1 site (Bern)
• Trial ID: NCT06894550 on ClinicalTrials.gov

What this trial studies

This study investigates the safety of short-term exposure to high altitude in patients with asymptomatic moderate or severe aortic stenosis. Participants will be escorted to high altitude and undergo a series of tests to measure cardiac function and potential adverse events. The study aims to assess changes in exercise capacity, cardiac filling pressures, dimensions, and the incidence of arrhythmias due to high altitude exposure. The findings could provide valuable insights into the risks associated with high altitude activities for these patients.

Who should consider this trial

Good fit: Ideal candidates include individuals with moderate or severe aortic stenosis who are asymptomatic and have a left ventricular ejection fraction greater than 50%.

Not a fit: Patients with symptomatic aortic stenosis or those with uncontrolled hypertension or other significant cardiac conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could help clarify the safety of high altitude exposure for patients with aortic stenosis, potentially allowing them to participate in leisure activities at high altitudes.

How similar studies have performed: Previous studies have suggested that short-term high altitude exposure is well tolerated in patients with certain cardiovascular conditions, indicating potential for success in this approach.

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)

Where this trial is running

Bern

• University Hospital Inselspital, Bern — Bern, Switzerland (Recruiting)

Study contacts

• Study coordinator: Thomas Pilgrim, MD, MSc

Conditions Aortic Stenosis; Altitude; Aortic stenosis; High altitude