Arrhythmias, CardiacSUMMITNCT05676398
Cardiac Arrhythmias at Extreme Altitude
An observational study of Arrhythmias, Cardiac and Tachycardia, Ventricular, run by Insel Gruppe AG, University Hospital Bern at 1 site in Nepal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Arrhythmias, Cardiac, Tachycardia, Ventricular, Tachycardia, Supraventricular
- What is being tested?
- Ambulatory rhythm recording
- How many people
- 30 participants
- Where
- 1 siteNepal
- Study dates
- 1 Jan 2023to 30 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers climbing Mount Everest.
Who may be able to join
- Age ≥18 years
- Normal electrocardiogram
- Normal echocardiography
- Written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Nepal1 site, 1 recruiting
- Recruiting
National Academy of Medical Sciences, Bir Hospital
Kathmandu
Kunjang Sherpa, MD
About this study
Official title: 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.
Read the 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
- Being tested
- Ambulatory rhythm recording
- Medical subject headings
- Arrhythmias, Cardiac, Tachycardia, Ventricular, Tachycardia, Supraventricular, Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambulatory rhythm recordingDiagnostic test
Ambulatory rhythm recording by use of a wearable patch-type device.
| Study group | Role | What they receive |
|---|---|---|
| Ambulatory rhythm monitoring | Ambulatory rhythm monitoring by use of patch-type device. Receives: Diagnostic Test: Ambulatory rhythm recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants detected to have cardiac arrhythmia
Composite of supraventricular and ventricular tachyarrhythmias, and bradyarrhythmias.
Measured: 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
Occurrence of the composite of supraventricular and ventricular tachyarrhythmias, and bradyarrhythmias.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start1 Jan 2023
- Primary completion1 Jun 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arrhythmias, CardiacStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- National Academy of Medical Sciences, Nepal
- Responsible party
- Sponsor
- Investigators
- Thomas Pilgrim, MD, Principal investigator, Bern University Hospital, University of Bern, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05676398
- Sponsor's protocol ID
- 2659
- Acronym
- SUMMIT
- Status last verified
- Dec 2022
- First submitted
- 22 Dec 2022
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk of Cardiac Arrhythmias at Extreme Altitude
- ClinicalTrials.gov ID
- NCT05676398
- Acronym / sponsor ID
- SUMMIT / 2659
- Conditions
- Arrhythmias, Cardiac, Tachycardia, Ventricular, Tachycardia, Supraventricular, Bradycardia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- National Academy of Medical Sciences, Nepal
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 9 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ambulatory rhythm monitoring | – | Diagnostic Test: Ambulatory rhythm recordingAmbulatory rhythm monitoring by use of patch-type device. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers climbing Mount Everest.
Key inclusion criteria (4 listed)
- Age ≥18 years
- Normal electrocardiogram
- Normal echocardiography
- Written informed consent
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ambulatory rhythm recordingAmbulatory rhythm recording by use of a wearable patch-type device. | Diagnostic test | Ambulatory rhythm monitoring |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Pilgrim, MD principal investigator
Bern University Hospital, University of Bern, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arrhythmias, Cardiac and Tachycardia, Ventricular, run by Insel Gruppe AG, University Hospital Bern at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laura Morf, PhD (0041 31 632 21 11, laura.morf@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2023.