Cardiac Arrhythmias at Extreme Altitude

NCT05676398 | Unknown

• 1 other identifier: 2659
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• Patterns in the occurrence of cardiac arrhythmias

  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.

Study Arms (1)

Ambulatory rhythm monitoring

Ambulatory rhythm monitoring by use of patch-type device.

Diagnostic Test: Ambulatory rhythm recording

Interventions

Ambulatory rhythm recording DIAGNOSTIC_TEST

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

Ambulatory rhythm monitoring

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers climbing Mount Everest.

You may qualify if:

• Age ≥18 years
• Normal electrocardiogram
• Normal echocardiography
• Written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• National Academy of Medical Sciences, Nepal: collaborator

Study Sites (1)

National Academy of Medical Sciences, Bir Hospital

Kathmandu, Nepal

RECRUITING

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tachycardia; Cardiac Conduction System Disease

Study Officials

• Thomas Pilgrim, MD

  Bern University Hospital, University of Bern, Switzerland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Morf, PhD

CONTACT

0041 31 632 21 11; laura.morf@insel.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2022
• First Posted: January 9, 2023
• Study Start: January 1, 2023
• Primary Completion: June 1, 2023
• Study Completion: September 30, 2023
• Last Updated: January 18, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)