Coronary Artery Disease (CAD)Hyx-PRE-SpoNCT04725539
Hypoxia Pre-conditioning and Mountain Sport
A study testing hypoxic exposure in people with Coronary Artery Disease (CAD), run by Institute of Mountain Emergency Medicine at 1 site in Italy.
Trial summary
Mountain sport activities as for example hiking or skiing may involve the risk of adverse health events especially in older people not accustomed to the specific mountain sport at altitude or people with pre-existing health issues. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Coronary Artery Disease (CAD)
- What is being tested?
- hypoxic exposure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2022to 31 Oct 2024
- Phase
- Interventional
- 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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants will include normally physically active males and females (age 50-70 years; New York Heart Association (NYHA) class I and II) with or without prior myocardial infarction, living <600 m.
Who cannot join
- Persons with CAD will be excluded if they will not be able to perform light to moderate exercise, or had recent myocardial infarction and/or revascularisation (< 8 weeks prior to inclusion in the study), episode of unstable angina, de-compensated heart failure, life-threatening arrhythmia, ejection fraction < 50%, known symptomatic aortic outflow obstruction, severe hypertension (>180/100 mm Hg), pulmonary hypertension or any other severe systemic non-cardiac disease. Exclusion criteria will additionally include regular smoking of more than five cigarettes per day, regular drug intake, habitual residence > 600 m and one or more overnight stay at > 1000 m during the previous 4 weeks.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Hypoxia Pre-conditioning on Physiological Responses During Mountain Sport Activities in Persons With a History of Coronary Artery Disease
Mountain sport activities as for example hiking or skiing may involve the risk of adverse health events especially in older people not accustomed to the specific mountain sport at altitude or people with pre-existing health issues. Increased activation of the sympathetic nervous system and abrupt changes in heart rate and blood pressure are thought to trigger these adverse effects. Preventive measures include regular physical activity (i.e. training) and adequate medical treatment. Hypoxia pre-adaptation (e.g., pre-adapt one night at moderate altitude) and pre-conditioning (e.g., intermittent hypoxia (IH) training), which was shown to lead to some favorable sympathetic nervous system, ventilatory and metabolic adaptations and additionally exerts anti-inflammatory action, could be hypothesized of being a further preventive measure. The aim of this research project is to investigate whether intermittent hypoxia pre-conditioning or sleeping one night at altitude (i.e., current recommendation before practicing mountain leisure sports in the elderly) is able to increase oxygen saturation during passive hypoxia exposure and during simulated hiking and skiing at altitude. Additionally, it is aimed to investigate whether such procedure reduces the physiological responses (i.e., heart rate, its variability and blood pressure (including baroreflex sensitivity) responses as well as metabolic, ventilatory, inflammatory and redox responses) during these activities.
- Conditions
- Coronary Artery Disease (CAD)
- Being tested
- hypoxic exposure
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypoxic exposureProcedure or surgery
Administration of different hypoxic doses.
Intermittent hypoxia:
days 1-5 duration of breathing periods 5*3min (FiO2 14-21%) days 8-12 duration of breathing periods 4*4min (FiO2 = 12%) and 3*3 min (FiO2 = 21%) days 15-19 duration of breathing periods 5*5min (FiO2 = 10%) and 4*3 min (FiO2 = 21%)
one night at 1900m
| Study group | Role | What they receive |
|---|---|---|
| Intermittent hypoxia (IH) pre-conditioning | Experimental | The IH pre-conditioning program will be performed in a sitting position by inhaling a gas mixture with reduced O2 content via face masks.The program will include five sessions per week for 3 weeks. Each session consists of three to five hypoxic (14-10% inspired fraction of oxygen) periods, each lasting 3-5 min with 3-min normoxic intervals.
The control setting includes breathing room air via face mask. Receives: Procedure: hypoxic exposure |
| Hypoxia pre-adaptation | Experimental | The hypoxia pre-adaptation program consists of sleeping 1 night at 1900m. The control setting includes sleeping 1 night close to sea level. Receives: Procedure: hypoxic exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting oxygen saturation (%) at altitude
Resting oxygen saturation changes after the pre-conditioning and pre-adaptation program at 3000 m altitude
Measured: Through study completion, an average of 1.5 years
Oxygen saturation during exercise at altitude
Oxygen saturation during exercise changes after the pre-conditioning and pre-adaptation program at 3000 m altitude
Measured: Through study completion, an average of 1.5 years
Secondary outcomes (7)
Heart rate (bpm) responses during rest and during exercise at altitude
Heart rate response changes after the pre-conditioning and pre-adaptation program at rest and during exercise at 3000 m altitude.
Measured: Through study completion, an average of 1.5 years
Blood pressure (mmHg) responses during rest and during exercise at altitude
Blood pressure responses during rest and during exercise at altitude
Measured: Through study completion, an average of 1.5 years
Changes of inflammatory markers (i.e., hsCRP) from before to after the pre-conditioning and pre-adaptation program
Inflammatory markers may change due to the programs
Measured: Through study completion, an average of 1.5 years
Changes of physiological stress markers (i.e., catecholamine) from before to after the pre-conditioning and pre-adaptation program
Markers of physiological stress may change due to the programs
Measured: Through study completion, an average of 1.5 years
Changes in heart rate variability (HRV) from before to after the pre-conditioning and pre-adaptation program
HRV may change due to the programs
Measured: Through study completion, an average of 1.5 years
Changes in baroreflex sensitivity (BRS) from before to after the pre-conditioning and pre-adaptation program
BRS may change due to the programs
Measured: Through study completion, an average of 1.5 years
Changes of markers of myocardial injury (e.g., highly sensitive cardiac troponin T) from before to after the pre-conditioning and pre-adaptation program
Markers of myocardial injury may change due to the programs
Measured: Through study completion, an average of 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start1 Jan 2022
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Disease (CAD)Studies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Mountain Emergency Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Istituto Auxologico Italiano, University of Innsbruck, Austria, University of Giessen
- Responsible party
- Sponsor
- Investigators
- Hannes Gatterer, PhD, Principal investigator, Institute of Mountain Emergency Medicine, EURAC Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04725539
- Sponsor's protocol ID
- HYP-P-SP
- Acronym
- Hyx-PRE-Spo
- Status last verified
- Aug 2025
- First submitted
- 8 Jan 2021
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data underlying scientific publications will be stored in open repositories (accessible).
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hypoxia Pre-conditioning on Physiological Responses During Mountain Sport Activities in Persons With a History of Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT04725539
- Acronym / sponsor ID
- Hyx-PRE-Spo / HYP-P-SP
- Conditions
- Coronary Artery Disease (CAD)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Institute of Mountain Emergency MedicineUniversity, hospital or other
- Collaborators
- Istituto Auxologico Italiano, University of Innsbruck, Austria, University of Giessen
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 26 Jan 2021 (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.
Mountain sport activities as for example hiking or skiing may involve the risk of adverse health events especially in older people not accustomed to the specific mountain sport at altitude or people with pre-existing health issues. Increased activation of the sympathetic nervous system and abrupt changes in heart rate and blood pressure are thought to trigger these adverse effects. Preventive measures include regular physical activity (i.e. training) and adequate medical treatment. Hypoxia pre-adaptation (e.g., pre-adapt one night at moderate altitude) and pre-conditioning (e.g., intermittent hypoxia (IH) training), which was shown to lead to some favorable sympathetic nervous system, ventilatory and metabolic adaptations and additionally exerts anti-inflammatory action, could be hypothesized of being a further preventive measure. The aim of this research project is to investigate whether intermittent hypoxia pre-conditioning or sleeping one night at altitude (i.e., current recommendation before practicing mountain leisure sports in the elderly) is able to increase oxygen saturation during passive hypoxia exposure and during simulated hiking and skiing at altitude. Additionally, it is aimed to investigate whether such procedure reduces the physiological responses (i.e., heart rate, its variability and blood pressure (including baroreflex sensitivity) responses as well as metabolic, ventilatory, inflammatory and redox responses) during these activities.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermittent hypoxia (IH) pre-conditioning | Experimental | Procedure: hypoxic exposureThe IH pre-conditioning program will be performed in a sitting position by inhaling a gas mixture with reduced O2 content via face masks.The program will include five sessions per week for 3 weeks. Each session consists of three to five hypoxic (14-10% inspired fraction of oxygen) periods, each lasting 3-5 min with 3-min normoxic intervals. The control setting includes breathing room air via face mask. |
| Hypoxia pre-adaptation | Experimental | Procedure: hypoxic exposureThe hypoxia pre-adaptation program consists of sleeping 1 night at 1900m. The control setting includes sleeping 1 night close to sea level. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants will include normally physically active males and females (age 50-70 years; New York Heart Association (NYHA) class I and II) with or without prior myocardial infarction, living <600 m.
Key exclusion criteria (1 listed)
- Persons with CAD will be excluded if they will not be able to perform light to moderate exercise, or had recent myocardial infarction and/or revascularisation (< 8 weeks prior to inclusion in the study), episode of unstable angina, de-compensated heart failure, life-threatening arrhythmia, ejection fraction < 50%, known symptomatic aortic outflow obstruction, severe hypertension (>180/100 mm Hg), pulmonary hypertension or any other severe systemic non-cardiac disease. Exclusion criteria will additionally include regular smoking of more than five cigarettes per day, regular drug intake, habitual residence > 600 m and one or more overnight stay at > 1000 m during the previous 4 weeks.
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 |
|---|---|---|
| hypoxic exposureAdministration of different hypoxic doses. Intermittent hypoxia: days 1-5 duration of breathing periods 5*3min (FiO2 14-21%) days 8-12 duration of breathing periods 4*4min (FiO2 = 12%) and 3*3 min (FiO2 = 21%) days 15-19 duration of breathing periods 5*5min (FiO2 = 10%) and 4*3 min (FiO2 = 21%) one night at 1900m | Procedure or surgery | Hypoxia pre-adaptation, Intermittent hypoxia (IH) pre-conditioning |
Primary outcome
Resting oxygen saturation (%) at altitude
Time frame: Through study completion, an average of 1.5 years
Resting oxygen saturation changes after the pre-conditioning and pre-adaptation program at 3000 m altitude
Oxygen saturation during exercise at altitude
Time frame: Through study completion, an average of 1.5 years
Oxygen saturation during exercise changes after the pre-conditioning and pre-adaptation program at 3000 m altitude
7 secondary outcomes
Heart rate (bpm) responses during rest and during exercise at altitude
Time frame: Through study completion, an average of 1.5 years
Blood pressure (mmHg) responses during rest and during exercise at altitude
Time frame: Through study completion, an average of 1.5 years
Changes of inflammatory markers (i.e., hsCRP) from before to after the pre-conditioning and pre-adaptation program
Time frame: Through study completion, an average of 1.5 years
Changes of physiological stress markers (i.e., catecholamine) from before to after the pre-conditioning and pre-adaptation program
Time frame: Through study completion, an average of 1.5 years
Changes in heart rate variability (HRV) from before to after the pre-conditioning and pre-adaptation program
Time frame: Through study completion, an average of 1.5 years
Changes in baroreflex sensitivity (BRS) from before to after the pre-conditioning and pre-adaptation program
Time frame: Through study completion, an average of 1.5 years
Changes of markers of myocardial injury (e.g., highly sensitive cardiac troponin T) from before to after the pre-conditioning and pre-adaptation program
Time frame: Through study completion, an average of 1.5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Individual participant dataSharing planned: Yes. Data underlying scientific publications will be stored in open repositories (accessible).
Related trials for Coronary Artery Disease (CAD)
Recruiting
Pivotal Study of the SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervention (HRPCI)
Coronary Artery Disease, High Risk Percutaneous Coronary Intervention
RecruitingPhase 3
A Clinical Trial To Investigate The Effect Of EA-230 On Hospital Length Of Stay In Patients With Coronary Artery Disease (CAD) Undergoing Coronary Artery Bypass Grafting (CABG) Surgery.
Coronary Artery Disease (CAD), Coronary Artery Bypass Graft Surgery(CABG)
Enrolling by invitationObservational study
Simultaneous Measurement of EpicArdial and Microvascular ResisTance Via Angiographic FLOW Study
Non-obstructive Coronary Disease, Acute or Chronic Coronary Artery Disease
Recruiting
Aggressive Lipid Lowering Therapy in ICI-Treated Melanoma
Melanoma
Recruiting
AVS Pulse Intravascular Lithotripsy™ (Pulse IVL™) to Open Vessels With Calcific Walls and Enhance Vascular Compliance and Remodeling for Coronary Artery Disease
Coronary Arterial Disease (CAD)
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.
Hannes Gatterer, PhD principal investigator
Institute of Mountain Emergency Medicine, EURAC Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hypoxic exposure in people with Coronary Artery Disease (CAD), run by Institute of Mountain Emergency Medicine at 1 site in Italy.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 12 Aug 2025. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resting oxygen saturation (%) at altitude (time frame: Through study completion, an average of 1.5 years). The study lists 2 primary outcomes in all. 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 12 Aug 2025.