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

NCT06894550 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-03-25

No results posted yet for this study

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.

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)

Sponsors & Collaborators

  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Principal Investigators

  • Thomas Pilgrim, MD, MSc · University Hospital of Bern, Bern, Switzerland

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2026-04-01
Completion
2026-09-01

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06894550 on ClinicalTrials.gov