Cardiac Arrhythmias at Extreme Altitude

NCT ID: NCT05676398

Last Updated: 2023-01-18

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2023-09-30

Brief Summary

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.

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.

Conditions

Arrhythmias, Cardiac; Tachycardia, Ventricular; Tachycardia, Supraventricular; Bradycardia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Ambulatory rhythm monitoring

Ambulatory rhythm monitoring by use of patch-type device.

Ambulatory rhythm recording

Intervention Type: DIAGNOSTIC_TEST

Ambulatory rhythm recording by use of a wearable patch-type device.

Interventions

Ambulatory rhythm recording

Ambulatory rhythm recording by use of a wearable patch-type device.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Academy of Medical Sciences, Nepal

OTHER_GOV

Sponsor Role: collaborator

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Pilgrim, MD

Role: PRINCIPAL_INVESTIGATOR

Bern University Hospital, University of Bern, Switzerland

Locations

National Academy of Medical Sciences, Bir Hospital

Kathmandu, , Nepal

Site Status: RECRUITING

Countries

Nepal

Central Contacts

Laura Morf, PhD

Role: CONTACT

laura.morf@insel.ch

0041 31 632 21 11

Facility Contacts

Kunjang Sherpa, MD

Role: primary

Other Identifiers

2659

Identifier Type: -

Identifier Source: org_study_id