Cardiac Arrhythmias at Extreme Altitude (SUMMIT)

January 13, 2023 updated by: University Hospital Inselspital, Berne

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

Recruiting

Conditions

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

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Nepal
      • Kathmandu, Nepal
        • Recruiting
        • National Academy of Medical Sciences, Bir Hospital
        • Contact:
          • Kunjang Sherpa, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy volunteers climbing Mount Everest.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ambulatory rhythm monitoring
Ambulatory rhythm monitoring by use of patch-type device.
Diagnostic test: Ambulatory rhythm recording
Ambulatory rhythm recording by use of a wearable patch-type device.

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.
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 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Inselspital, Berne

Collaborators

National Academy of Medical Sciences, Nepal

Investigators

  • Principal Investigator: Thomas Pilgrim, MD, Bern University Hospital, University of Bern, Switzerland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

September 30, 2023

Study Registration Dates

First Submitted

December 22, 2022

First Submitted That Met QC Criteria

December 22, 2022

First Posted (Actual)

January 9, 2023

Study Record Updates

Last Update Posted (Actual)

January 18, 2023

Last Update Submitted That Met QC Criteria

January 13, 2023

Last Verified

December 1, 2022

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)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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