High-altitude exposure in patients with cardiovascular disease: risk assessment and practical recommendations.
Stefano F Rimoldi, Claudio Sartori, Christian Seiler...
https://pubmed.ncbi.nlm.nih.gov/20417345Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID06894550
Short-term Exposure to High Altitude in Patients With Asymptomatic Aortic Stenosis
Led by Insel Gruppe AG, University Hospital Bern · Updated on 2025-03-25
60
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Aortic stenosis is a common heart valve disease that becomes more frequent with age. This research aims to study the safety of short-term exposure to high altitude in patients who have moderate or severe aortic stenosis but no symptoms. The study focuses on measuring changes in exercise capacity, heart pressures, heart size and function, and the occurrence of heart rhythm problems during altitude exposure. Participants will be accompanied to high altitudes of 540 meters and 3545 meters above sea level for testing. They will undergo various evaluations including electrocardiograms, echocardiography to measure heart dimensions and function, exercise stress tests with focused heart imaging and blood gas analysis, 24-hour heart rhythm monitoring, and blood tests for cardiac biomarkers and other lab values. The study groups include patients with asymptomatic moderate or severe aortic stenosis, patients who had aortic valve replacement within the past year, and healthy older adults matched by age and sex. During the study visit at high altitude, participants will be closely monitored for symptoms and heart function changes. The primary outcomes measured include exercise performance, heart ultrasound findings, heart rhythm changes, and safety markers assessed after about 3 to 4 hours at 3545 meters altitude. Additional evaluations include symptoms, lab values, arrhythmia occurrence, and hemodynamic effects. The study aims to provide new information about how patients with aortic stenosis tolerate high altitude exposure.
CONDITIONS
Brief Title
Short-term Exposure to High Altitude in Patients With Asymptomatic Aortic Stenosis
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Moderate or severe aortic stenosis with aortic valve area of 1.5 cm2 or less (Group 1)
- New York Heart Association (NYHA) class I symptoms
- Left ventricular ejection fraction (LVEF) greater than 50%
- Aortic stenosis staging classification Stage 0 or 1
- Provided written informed consent
- Aortic stenosis status after aortic valve replacement within 1 year (Group 2)
- Age over 65 years with no evidence of valvular heart disease (Group 3)
- NYHA class I and LVEF greater than 50% (Group 3)
- Provided written informed consent
You will not qualify if you...
- NYHA class higher than I for all groups
- History of cardiac decompensation requiring hospitalization
- Uncontrolled arterial hypertension above 180/100 mmHg at rest
- Other cardiomyopathies with normal LVEF, including dilatative, hypertrophic, or infiltrative types
- Signs of exercise-induced ischemia or hemodynamic instability during stress testing
- Ventricular arrhythmias exceeding 5 beats during stress testing
- Chronic obstructive pulmonary disease with forced expiratory volume in 1 second (FEV1) less than 60% predicted
- Known pulmonary hypertension with pulmonary artery systolic pressure over 50 mmHg
- NT-pro BNP levels higher than 900 pg/ml
- Aortic stenosis staging classification above Stage 1 (Groups 1 and 2)
- History of advanced acute mountain sickness such as high altitude pulmonary or cerebral edema
- Transvalvular gradient across the aortic valve 60 mmHg or higher, or Vmax over 5 m/s (Group 1)
- Vmax progression of 0.3 m/s or more per year (Group 1)
- Transvalvular gradient across the aortic valve 20 mmHg or higher (Group 2)
- Evidence of valvular heart disease or coronary artery disease (Group 3)
- History of rhythm disturbances other than premature ventricular contractions (Group 3)
- Right ventricular dysfunction defined as TAPSE less than 17 mm or s'DTI less than 9 cm/sec
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Exposure and Assessment at High Altitude
Duration - Several hours on the day of high altitude exposure
Participants are escorted to high altitude and undergo a series of examinations including electrocardiogram, echocardiography, cardiopulmonary exercise testing, 24-hour wearable rhythm monitoring, and blood work both at low altitude (540m) and high altitude (3545m) to evaluate hemodynamic response and safety.
1 visit at 540m and 1 visit at 3545m (in-person)
Trial Site Locations
Total: 1 location
1
University Hospital Inselspital, Bern
Bern, Switzerland, CH-3010
Actively Recruiting
Loading map...
Research Team
T
Thomas Pilgrim, MD, MSc
M
Marius R Bigler, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Short-term high altitude exposure at 3454 m is well tolerated in patients with stable heart failure.
Jean-Paul Schmid, Daniel Nobel, Nicolas Brugger...
https://pubmed.ncbi.nlm.nih.gov/25597947Safety and exercise tolerance of acute high altitude exposure (3454 m) among patients with coronary artery disease.
J-P Schmid, M Noveanu, R Gaillet...
https://pubmed.ncbi.nlm.nih.gov/16339809