Cardiac Arrhythmias at Extreme Altitude (SUMMIT)
Risk of Cardiac Arrhythmias at Extreme Altitude
Background: Exposure to high altitudes has been associated with an increased risk of cardiac arrhythmias in healthy subjects and an increased risk of sudden cardiac death.
Aim: The aim of the present study is to evaluate the risk and the incidence of cardiac arrhythmias at extreme altitude.
Methods: This is a prospective cohort study of healthy volunteers determined to climb Mount Everest. Subjects will be evaluated for eligibility by electrocardiography and echocardiography. All study participants will undergo ambulatory rhythm monitoring in their home environment within 12 weeks of the climb. Subsequently, ambulatory rhythm monitoring will be repeated during the ascent from basecamp to the summit of Mount Everest. The primary endpoint will be the composite of supraventricular and ventricular tachyarrhythmias, and bradyarrhythmias.
Study Overview
Status
Intervention / Treatment
Detailed Description
Background: Several physiological changes at high altitude give rise to a pro-arrhythmic milieu. A fall in atmospheric pressure at high altitude decreases the partial pressure of oxygen (PaO2) and causes arterial hypoxemia. Respiratory alkalosis secondary to hyperventilation causes hypokalemia and hypocalcemia. Both factors facilitate the occurrence of rhythm disturbances, and may be further exacerbated in an adrenergic state with increased epinephrin levels.
Objectives: The primary objective is to investigate the incidence of supraventricular and ventricular tachyarrhythmias, and the incidence of bradyarrhythmias in climbers during the ascent of Mount Everest. The secondary objective is to investigate clinical, electrocardiographic and echocardiographic predictors of cardiac arrhythmias at extreme altitude.
Methods: This is a prospective cohort study of healthy volunteers climbing Mount Everest. Subjects will be evaluated for eligibility by electrocardiography and echocardiography. All participants will undergo a stress test in order to rule out pre-existing rhythm disturbances during exercise. Study participants will undergo ambulatory rhythm monitoring in their home environment within 12 weeks of the climb. Subsequently, subjects will repeat ambulatory rhythm monitoring during the ascent from basecamp to the summit of Mount Everest. The subjects will act as their own controls.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Laura Morf, PhD
- Phone Number: 0041 31 632 21 11
- Email: laura.morf@insel.ch
Study Locations
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Kathmandu, Nepal
- Recruiting
- National Academy of Medical Sciences, Bir Hospital
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Contact:
- Kunjang Sherpa, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age ≥18 years
- Normal electrocardiogram
- Normal echocardiography
- Written informed consent
Exclusion Criteria:
- Known cardiac arrhythmia
- Evidence of AV-block, left bundle branch block, or repolarization disorders on electrocardiogram
- Evidence of structural heart disease (valve disease more than mild) or compromised left ventricular ejection fraction as assessed by echocardiography
- Symptoms or history of skin cancer, rash, skin disease, keloid or injury
- Cardiac pacemakers, cardiac defibrillators, implantable electrical devices
- Pregnancy, breastfeeding
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Ambulatory rhythm monitoring
Ambulatory rhythm monitoring by use of patch-type device.
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Ambulatory rhythm recording by use of a wearable patch-type device.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of participants detected to have cardiac arrhythmia
Time Frame: The primary endpoint will be assessed during the ascent from basecamp to the summit of Mount Everest and back to basecamp, expected to be on average 5-10 days.
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Composite of supraventricular and ventricular tachyarrhythmias, and bradyarrhythmias.
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The primary endpoint will be assessed during the ascent from basecamp to the summit of Mount Everest and back to basecamp, expected to be on average 5-10 days.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patterns in the occurrence of cardiac arrhythmias
Time Frame: The outcome will be assessed during the ascent from basecamp to the summit of Mount Everest and back to basecamp, expected to be on average 5-10 days.
|
Occurrence of the composite of supraventricular and ventricular tachyarrhythmias, and bradyarrhythmias.
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The outcome will be assessed during the ascent from basecamp to the summit of Mount Everest and back to basecamp, expected to be on average 5-10 days.
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Thomas Pilgrim, MD, Bern University Hospital, University of Bern, Switzerland
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2659
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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