Hypertension, PulmonaryHEXABMNCT04715113
Blood Markers Predict Effect of Normobaric Hypoxia at Rest and During Exercise in Patients With Pulmonary Hypertension
A study testing Normobaric hypoxia (FiO2 15%) and Normobaric hypoxia (FiO2 15%) under Sildenafil in people with Hypertension, Pulmonary, run by University of Zurich at 1 site in Switzerland.
Trial summary
To study the effect of acute normobaric hypoxia during exercise in patients with pulmonary hypertension on blood markers (serum markers of iron and red blood cell homeostasis and micro-RNAs known to be associated with PH). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Pulmonary
- What is being tested?
- Normobaric hypoxia (FiO2 15%) and Normobaric hypoxia (FiO2 15%) under Sildenafil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Feb 2021to 31 May 2023
- 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 as documented by signature (Appendix Informed Consent Form)
- PH class I (PAH) or IV (CTEPH) diagnosed according to guidelines: mean pulmonary artery pressure >20 mmHg, pulmonary vascular resistance ≥3 wood units, pulmonary arterial wedge pressure ≤15 mmHg during baseline measures at the diagnostic right-heart catheterization
Who cannot join
- resting partial pressure of oxygen <8 kilopascal at Zürich altitude on ambient air
- exposure to an altitude >1000 m for ≥3 nights during the last 2 weeks before the study
- inability to follow the procedures of the study
- patients who take nitrates
- other clinically significant concomitant end-stage disease (e.g., renal failure, hepatic dysfunction)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hemodynamic Effects of Acute Normobaric Hypoxia During Exercise in Patients With Pulmonary Hypertension: Single-center Randomized Controlled Trial
To study the effect of acute normobaric hypoxia during exercise in patients with pulmonary hypertension on blood markers (serum markers of iron and red blood cell homeostasis and micro-RNAs known to be associated with PH).
- Conditions
- Hypertension, Pulmonary
- Being tested
- Normobaric hypoxia (FiO2 15%), Placebo-ambient air (FiO2 21%), Normobaric hypoxia (FiO2 15%) under Sildenafil, Placebo-ambient air (FiO2 21%) under Sildenafil
- Keywords
- hypoxia, exercise, blood markers
- Medical subject headings
- Hypertension, Pulmonary, Hypoxia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normobaric hypoxia (FiO2 15%)Other
Inhalation of deoxygenated air through an altitude simulator ("Altitrainer"), for approx. 1/2 hour given by a facemask, first at rest and then during exercise.
Placebo-ambient air (FiO2 21%)Other
Inhalation of room air through an altitude simulator ("Altitrainer"), for approx. 1/2 hour given by a facemask, first at rest and then during exercise.
Normobaric hypoxia (FiO2 15%) under SildenafilOther
Inhalation of deoxygenated air through an altitude simulator ("Altitrainer"), for approx. 1/2 hour given by a facemask, first at rest and then during exercise under Sildenafil.
Placebo-ambient air (FiO2 21%) under SildenafilOther
Inhalation of room air through an altitude simulator ("Altitrainer"), for approx. 1/2 hour given by a facemask, first at rest and then during exercise under Sildenafil.
| Study group | Role | What they receive |
|---|---|---|
| Normobaric hypoxia (FiO2 15%) | Experimental | Inhalation of deoxygenated air through an altitude simulator ("Altitrainer"), for approx. 1/2 hour given by a facemask, first at rest and then during exercise. Receives: Other: Normobaric hypoxia (FiO2 15%) |
| Placebo-ambient air (FiO2 21%) | Sham comparator | Inhalation of room air through an altitude simulator ("Altitrainer"), for approx. 1/2 hour given by a facemask, first at rest and then during exercise. Receives: Other: Placebo-ambient air (FiO2 21%) |
| Normobaric hypoxia (FiO2 15%) under Sildenafil | Experimental | Inhalation of deoxygenated air through an altitude simulator ("Altitrainer"), for approx. 1/2 hour given by a facemask, first at rest and then during exercise. Receives: Other: Normobaric hypoxia (FiO2 15%) under Sildenafil |
| Placebo-ambient air (FiO2 21%) under Sildenafil | Active comparator | Inhalation of room air through an altitude simulator ("Altitrainer"), for approx. 1/2 hour given by a facemask, first at rest and then during exercise. Receives: Other: Placebo-ambient air (FiO2 21%) under Sildenafil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum levels of ferritin
Analyis of serum levels of ferritin
Measured: Baseline
Secondary outcomes (6)
Serum levels of transferrin
Analyis of serum levels of transferrin
Measured: Baseline
Serum levels of total iron
Analysis of serum levels of total iron
Measured: Baseline
Serum levels of erythropoietin
Analysis of serum levels of erythropoietin
Measured: Baseline
Serum levels of Erythroferrone
Analysis of serum levels of erythroferrone
Measured: Baseline
Serum levels of hepcidin
Analysis of serum levels of hepcidin
Measured: Baseline
micro-RNA levels
Analysis of micro-RNA levels
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start1 Feb 2021
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension, PulmonaryStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Silvia Ulrich, Prof. Dr., Principal investigator, UniversityHospital Zurich, Department of Pulmonology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04715113
- Sponsor's protocol ID
- 2020-02163_A4
- Acronym
- HEXABM
- Status last verified
- May 2022
- First submitted
- 20 Dec 2020
- Last updated
- 6 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share individual participant data after publication of the manuscript. The decision about the platform is ongoing.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Effects of Acute Normobaric Hypoxia During Exercise in Patients With Pulmonary Hypertension: Single-center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04715113
- Acronym / sponsor ID
- HEXABM / 2020-02163_A4
- Conditions
- Hypertension, Pulmonary
- Keywords
- hypoxia, exercise, blood markers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 20 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.
To study the effect of acute normobaric hypoxia during exercise in patients with pulmonary hypertension on blood markers (serum markers of iron and red blood cell homeostasis and micro-RNAs known to be associated with PH).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Normobaric hypoxia (FiO2 15%) | Experimental | Other: Normobaric hypoxia (FiO2 15%)Inhalation of deoxygenated air through an altitude simulator ("Altitrainer"), for approx. 1/2 hour given by a facemask, first at rest and then during exercise. |
| Placebo-ambient air (FiO2 21%) | Sham comparator | Other: Placebo-ambient air (FiO2 21%)Inhalation of room air through an altitude simulator ("Altitrainer"), for approx. 1/2 hour given by a facemask, first at rest and then during exercise. |
| Normobaric hypoxia (FiO2 15%) under Sildenafil | Experimental | Other: Normobaric hypoxia (FiO2 15%) under SildenafilInhalation of deoxygenated air through an altitude simulator ("Altitrainer"), for approx. 1/2 hour given by a facemask, first at rest and then during exercise. |
| Placebo-ambient air (FiO2 21%) under Sildenafil | Active comparator | Other: Placebo-ambient air (FiO2 21%) under SildenafilInhalation of room air through an altitude simulator ("Altitrainer"), for approx. 1/2 hour given by a facemask, first at rest and then during exercise. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Informed consent as documented by signature (Appendix Informed Consent Form)
- PH class I (PAH) or IV (CTEPH) diagnosed according to guidelines: mean pulmonary artery pressure >20 mmHg, pulmonary vascular resistance ≥3 wood units, pulmonary arterial wedge pressure ≤15 mmHg during baseline measures at the diagnostic right-heart catheterization
Key exclusion criteria (5 listed)
- resting partial pressure of oxygen <8 kilopascal at Zürich altitude on ambient air
- exposure to an altitude >1000 m for ≥3 nights during the last 2 weeks before the study
- inability to follow the procedures of the study
- patients who take nitrates
- other clinically significant concomitant end-stage disease (e.g., renal failure, hepatic dysfunction)
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 |
|---|---|---|
| Normobaric hypoxia (FiO2 15%)Inhalation of deoxygenated air through an altitude simulator ("Altitrainer"), for approx. 1/2 hour given by a facemask, first at rest and then during exercise. | Other | Normobaric hypoxia (FiO2 15%) |
| Placebo-ambient air (FiO2 21%)Inhalation of room air through an altitude simulator ("Altitrainer"), for approx. 1/2 hour given by a facemask, first at rest and then during exercise. | Other | Placebo-ambient air (FiO2 21%) |
| Normobaric hypoxia (FiO2 15%) under SildenafilInhalation of deoxygenated air through an altitude simulator ("Altitrainer"), for approx. 1/2 hour given by a facemask, first at rest and then during exercise under Sildenafil. | Other | Normobaric hypoxia (FiO2 15%) under Sildenafil |
| Placebo-ambient air (FiO2 21%) under SildenafilInhalation of room air through an altitude simulator ("Altitrainer"), for approx. 1/2 hour given by a facemask, first at rest and then during exercise under Sildenafil. | Other | Placebo-ambient air (FiO2 21%) under Sildenafil |
Primary outcome
Serum levels of ferritin
Time frame: Baseline
Analyis of serum levels of ferritin
6 secondary outcomes
Serum levels of transferrin
Time frame: Baseline
Serum levels of total iron
Time frame: Baseline
Serum levels of erythropoietin
Time frame: Baseline
Serum levels of Erythroferrone
Time frame: Baseline
Serum levels of hepcidin
Time frame: Baseline
micro-RNA levels
Time frame: Baseline
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 6 Jun 2023.
- Individual participant dataSharing planned: Yes. We will share individual participant data after publication of the manuscript. The decision about the platform is ongoing.
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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, Prof. Dr. principal investigator
UniversityHospital Zurich, Department of Pulmonology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normobaric hypoxia (FiO2 15%) and Normobaric hypoxia (FiO2 15%) under Sildenafil in people with Hypertension, Pulmonary, 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 2 inclusion and 5 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 6 Jun 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 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. Some participants in this study may receive a placebo. 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?
Serum levels of ferritin (time frame: Baseline). 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 6 Jun 2023.