Pulmonary HypertensionNCT03581851
Acute Exposure of Simulated Hypoxia on ECG and Non-invasive Blood Pressure
A study testing Simulated Altitude: (FiO2: 15.1) in people with Pulmonary Hypertension, run by University of Zurich at 1 site in Switzerland.
Trial summary
Randomized crossover trial in patients with Pulmonary Hypertension (PAH, CTEPH) to assess the acute response to simulated altitude (FIO2: 15.1% = equivalent to 2500m above sea level) on ECG repolarizations and non-invasive blood pressure measurements by Finapres® NOVA Technology. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- Simulated Altitude: (FiO2: 15.1)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jul 2018to 1 Apr 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent
- PH diagnosed according to internation Guidelines: mean pulmonary artery pressure (mPAP) ≥ 25 mmHg along with a pulmonary artery wedge pressure (PAWP) ≤15 mmHg during right heart catheterization at the time of initial diagnosis
- PH class 1 (PAH) or 4 (CTEPH)
- Stable condition, on the same medication for > 4 weeks
- Patient live permanently at an altitude < 1000m asl.
Who cannot join
- Resting partial O2 pressure (PaO2) ≤7.3 kiloPascal (kPA) corresponding to the requirement of long-term oxygen therapy > 16hour daily (nocturnal oxygen therapy alone is allowed)
- Severe daytime hypercapnia (pCO2 > 6.5 kPa)
- Susceptibility to high altitude related diseases (AMS, High Altitude Pulmonary Edema (HAPE), etc.) based on previous experienced discomfort at altitudes.
- Exposure to an altitude >1500m for ≥3 nights during the last 4 weeks before the study participation
- Residence > 1000m above sea level
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, neurological or orthopedic problems with walking disability
- Women who are pregnant or breast feeding
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Respiratory Clinic, University Hospital of Zurich
Zurich, 8091
About this study
Official title: Acute Exposure to Hypoxia in Precapillary Pulmonary Hypertension: Physiological and Clinical Effects at Rest and During Exercise.
Randomized crossover trial in patients with Pulmonary Hypertension (PAH, CTEPH) to assess the acute response to simulated altitude (FIO2: 15.1% = equivalent to 2500m above sea level) on ECG repolarizations and non-invasive blood pressure measurements by Finapres® NOVA Technology.
Read the detailed description
Low altitude baseline measurements will be performed in Zurich (469m asl) including Echocardiography, right heart catheterization, six Minute Walking test (6MWT), pulmonary function test, clinical assessment and blood gas analysis at rest and under exercise. Randomly assigned to the order of testing, the participants will e tested under simulated altitude (FiO2: 15.1% with the "AMC Altitrainer") and shamed altitude with the same device. During the exposure to simulated altitude (FiO2: 15.1%) and shamed altitude of 1 hour each, the participants' ECG and non-invasively assessed blood pressure by Finapres at rest and under exercise will be collected.
- Conditions
- Pulmonary Hypertension
- Being tested
- Simulated Altitude: (FiO2: 15.1), Shamed Hypoxia (FiO2: 20.9)
- Keywords
- simulated altitude, exercise, electrocardiography, non- invasive blood pressure
- Medical subject headings
- Hypertension, Pulmonary, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulated Altitude: (FiO2: 15.1)Device
Inhalation of deoxygenated air through an altitude simulator ("Altitrainer") for approximately 1 hour given by a facemask.
Shamed Hypoxia (FiO2: 20.9)Device
Inhalation of unmodified air through an altitude simulator ("Altitrainer") for approximately 1 hour given by a facemask.
| Study group | Role | What they receive |
|---|---|---|
| Order Sham/Hypoxia | Experimental | The participants will be consecutively exposed to shamed hypoxia (FiO2: 20.9%) equivalent to sea level and to simulated altitude (FiO2: 15.1%) equivalent to 2500m above sea level administered by an altitude simulator ("Altitrainer", SMTEC) with a facemask. Receives: Device: Simulated Altitude: (FiO2: 15.1); Device: Shamed Hypoxia (FiO2: 20.9) |
| Order Hypoxia/Sham | Experimental | The participants will be consecutively exposed to hypoxia (FiO2: 15,1%) equivalent to 2500m above sea level and to shamed hypoxia (FiO2: 20.9%) equivalent to sea level administered by an altitude simulated ("Altitrainer", SMTEC) with a facemask. Receives: Device: Simulated Altitude: (FiO2: 15.1); Device: Shamed Hypoxia (FiO2: 20.9) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-invasive blood pressure (Finapres)
Change in non-invasive bloodpressure (systolic and diastolic) assessed with a finger cuff (Finapres) during the exposure to simulated altitude (FiO2: 15.1%) compared to normoxia
Measured: 1 hour
Secondary outcomes (1)
Electrocardiography
Change in cardiac repolarization during the exposure to simulated altitude (FiO2: 15.1%) compared to normoxia
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2018
- Study start1 Jul 2018
- Primary completion1 Apr 2019
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Including a baseline assessment and assessments under simulated altitude and normoxia
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Silvia Ulrich, MD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03581851
- Sponsor's protocol ID
- 2018-00455_A5
- Other IDs
- 2018
- Status last verified
- Jan 2020
- First submitted
- 20 Jun 2018
- Last updated
- 7 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Exposure to Hypoxia in Precapillary Pulmonary Hypertension: Physiological and Clinical Effects at Rest and During Exercise.
- ClinicalTrials.gov ID
- NCT03581851
- Acronym / sponsor ID
- 2018-00455_A5
- Conditions
- Pulmonary Hypertension
- Keywords
- simulated altitude, exercise, electrocardiography, non- invasive blood pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 10 Jul 2018 (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.
Randomized crossover trial in patients with Pulmonary Hypertension (PAH, CTEPH) to assess the acute response to simulated altitude (FIO2: 15.1% = equivalent to 2500m above sea level) on ECG repolarizations and non-invasive blood pressure measurements by Finapres® NOVA Technology.
Detailed description
Low altitude baseline measurements will be performed in Zurich (469m asl) including Echocardiography, right heart catheterization, six Minute Walking test (6MWT), pulmonary function test, clinical assessment and blood gas analysis at rest and under exercise. Randomly assigned to the order of testing, the participants will e tested under simulated altitude (FiO2: 15.1% with the "AMC Altitrainer") and shamed altitude with the same device. During the exposure to simulated altitude (FiO2: 15.1%) and shamed altitude of 1 hour each, the participants' ECG and non-invasively assessed blood pressure by Finapres at rest and under exercise will be collected.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Including a baseline assessment and assessments under simulated altitude and normoxia
| Arm | Type | Receives |
|---|---|---|
| Order Sham/Hypoxia | Experimental | Device: Simulated Altitude: (FiO2: 15.1), Device: Shamed Hypoxia (FiO2: 20.9)The participants will be consecutively exposed to shamed hypoxia (FiO2: 20.9%) equivalent to sea level and to simulated altitude (FiO2: 15.1%) equivalent to 2500m above sea level administered by an altitude simulator ("Altitrainer", SMTEC) with a facemask. |
| Order Hypoxia/Sham | Experimental | Device: Simulated Altitude: (FiO2: 15.1), Device: Shamed Hypoxia (FiO2: 20.9)The participants will be consecutively exposed to hypoxia (FiO2: 15,1%) equivalent to 2500m above sea level and to shamed hypoxia (FiO2: 20.9%) equivalent to sea level administered by an altitude simulated ("Altitrainer", SMTEC) with a facemask. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Informed consent
- PH diagnosed according to internation Guidelines: mean pulmonary artery pressure (mPAP) ≥ 25 mmHg along with a pulmonary artery wedge pressure (PAWP) ≤15 mmHg during right heart catheterization at the time of initial diagnosis
- PH class 1 (PAH) or 4 (CTEPH)
- Stable condition, on the same medication for > 4 weeks
- Patient live permanently at an altitude < 1000m asl.
Key exclusion criteria (7 listed)
- Resting partial O2 pressure (PaO2) ≤7.3 kiloPascal (kPA) corresponding to the requirement of long-term oxygen therapy > 16hour daily (nocturnal oxygen therapy alone is allowed)
- Severe daytime hypercapnia (pCO2 > 6.5 kPa)
- Susceptibility to high altitude related diseases (AMS, High Altitude Pulmonary Edema (HAPE), etc.) based on previous experienced discomfort at altitudes.
- Exposure to an altitude >1500m for ≥3 nights during the last 4 weeks before the study participation
- Residence > 1000m above sea level
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 |
|---|---|---|
| Simulated Altitude: (FiO2: 15.1)Inhalation of deoxygenated air through an altitude simulator ("Altitrainer") for approximately 1 hour given by a facemask. | Device | Order Hypoxia/Sham, Order Sham/Hypoxia |
| Shamed Hypoxia (FiO2: 20.9)Inhalation of unmodified air through an altitude simulator ("Altitrainer") for approximately 1 hour given by a facemask. | Device | Order Hypoxia/Sham, Order Sham/Hypoxia |
Primary outcome
Non-invasive blood pressure (Finapres)
Time frame: 1 hour
Change in non-invasive bloodpressure (systolic and diastolic) assessed with a finger cuff (Finapres) during the exposure to simulated altitude (FiO2: 15.1%) compared to normoxia
1 secondary outcome
Electrocardiography
Time frame: 1 hour
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 7 Jan 2020.
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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.
Silvia Ulrich, MD principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simulated Altitude: (FiO2: 15.1) in people with Pulmonary Hypertension, run by University of Zurich at 1 site in Switzerland.
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 5 inclusion and 7 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 7 Jan 2020. 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 Switzerland. 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?
Non-invasive blood pressure (Finapres) (time frame: 1 hour). 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 7 Jan 2020.