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| Name | Class |
|---|---|
| National Academy of Medical Sciences, Nepal | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ambulatory rhythm monitoring | Ambulatory rhythm monitoring by use of patch-type device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ambulatory rhythm recording | Diagnostic Test | Ambulatory rhythm recording by use of a wearable patch-type device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants detected to have cardiac arrhythmia | Composite of supraventricular and ventricular tachyarrhythmias, and bradyarrhythmias. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Patterns in the occurrence of cardiac arrhythmias | Occurrence of the composite of supraventricular and ventricular tachyarrhythmias, and bradyarrhythmias. | 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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Inclusion Criteria:
Exclusion Criteria:
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Healthy volunteers climbing Mount Everest.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laura Morf, PhD | Contact | 0041 31 632 21 11 | laura.morf@insel.ch |
| Name | Affiliation | Role |
|---|---|---|
| Thomas Pilgrim, MD | Bern University Hospital, University of Bern, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Academy of Medical Sciences, Bir Hospital | Recruiting | Kathmandu | Nepal |
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D017180 | Tachycardia, Ventricular |
| D013617 | Tachycardia, Supraventricular |
| D001919 | Bradycardia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| D013610 | Tachycardia |
| D000075224 | Cardiac Conduction System Disease |