Short-term Exposure to High Altitude in Patients With Asymptomatic Aortic Stenosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInsel Gruppe AG, University Hospital Bern
About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Participants will be escorted to high altitude and undergo a series of test
BehavioralParticipants 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)
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: Patients with asymptomatic moderate or severe aortic stenosisExperimental treatment 1 intervention
Group B: Patients with aortic stenosis s/p aortic valve replacementActive comparator 1 intervention
Group C: Age- and sex-matched healthy individualsActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Safety of high altitude exposure in patients with asymptomatic moderate or severe aortic stenosis. Spiroergometry outcome 1
Decrease in VO2 peak, i.e. VO2-peak @high altitude minus VO2-peak @ low altitude
Time frame
At end of the investigation at 3545m above sea level, expected to be on average after 3-4 hours2
Safety of high altitude exposure in patients with asymptomatic moderate or severe aortic stenosis. Spiroergometry outcome 2
Increase in VE/VCO2 slope, i.e. VE/VCO2 slope @high altitude minus VE/VCO2 slope @ low altitude
Time frame
At end of the investigation at 3545m above sea level, expected to be on average after 3-4 hours3
Safety of high altitude exposure in patients with asymptomatic moderate or severe aortic stenosis. Echocardiography outcome
Increase in left ventricular filling pressure (E/e'), i.e. E/e' @high altitude minus E/e' @ low altitude
Time frame
At end of the investigation at 3545m above sea level, expected to be on average after 3-4 hours4
Safety of high altitude exposure in patients with asymptomatic moderate or severe aortic stenosis. Rhythmologic outcome
Occurrence of ventricular tachycardia (\> 3 beats). Evaluated as presence versus absence.
Time frame
At end of the investigation at 3545m above sea level, expected to be on average after 3-4 hoursSecondary outcomes
1
Symptoms associated with the high altitude exposure
Clinical symptoms of congestive heart failure (NYHA functional class III/IV): Number of patients with newly developed symptoms at high altitude
Time frame
At end of the investigation at 3545m above sea level, expected to be on average after 3-4 hours2
Laboratory values associated with the high altitude exposure
Increase in NT-proBNP levels. Measurement = NTproBNP @high altitude minus NTproBNP @ low altitude
Time frame
At end of the investigation at 3545m above sea level, expected to be on average after 3-4 hours3
Arrhythmia associated with the high altitude exposure
Supraventricular or ventricular tachycardia. Number of patients with arrhythmia associated with the high altitude exposure
Time frame
At end of the investigation at 3545m above sea level, expected to be on average after 3-4 hours4
Hemodynamic effect of the high altitude exposure
Drop in blood pressure (\> 20 mmHg). Number of participants with a drop in blood pressure of \>20mmHg.
Time frame
At end of the investigation at 3545m above sea level, expected to be on average after 3-4 hoursSponsors and contacts
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Source ClinicalTrials.gov