Heart Failure, SystolichypoxheartNCT03537079
Hypoxic Conditioning in Heart Failure
A study testing hypoxia air in people with Heart Failure, Systolic, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Heart failure impairs quality of life and exercise capacity, despite an optimal medical therapy. Alternative methods, like hypoxic conditioning coupled to exercise training, must be explored and describe Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Heart Failure, Systolic
- What is being tested?
- hypoxia air
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- 5 Feb 2021to 4 Dec 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient available for exercise training
- stable heart failure state I-II New York Heart Association (NYHA) with altered ejection fraction (EF ≤ 40 %)
- signed informed consent
Who cannot join
- unstable ischemic cardiopathy
- right ventricle dysfunction
- uncontrolled arrythmias
- rest elevated in pulmonary artery pressure (≥ 45 mmHg)
- migraine
- high altitude trip above 2500 m high during study period
- impossibility to realise a maximal bicycle exercise test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hypoxic Conditioning Combined With Exercise Training in Heart Failure Patient: a Randomised, Controled, Single Blind Study
Heart failure impairs quality of life and exercise capacity, despite an optimal medical therapy. Alternative methods, like hypoxic conditioning coupled to exercise training, must be explored and describe
Read the detailed description
All heart failure patients will have a session of 45' of bicycle exercise training (in normoxia or hypoxia) AND a one hour rest session (in normoxia or hypoxia).
Exercise training sessions will consist in a continue bicycle exercise test at 70 to 80 % of the maximal heart rate, while breathing (single blind) normoxia or hypoxia gaz.
Rest conditioning consist in a one hour of rest, while breathing (single blind) normoxia or hypoxia gaz.
For hypoxia sessions, the oxygen saturation target will be fo 85-90 % for the 4 first weeks and 80-85 % for the last 4 weeks.
Three arms :
- exercise training in NORMOXIA and rest conditioning in NORMOXIA
- exercise training in HYPOXIA and rest conditioning in NORMOXIA
- exercise training in NORMOXIA and rest conditioning in HYPOXIA
- Conditions
- Heart Failure, Systolic
- Being tested
- hypoxia air
- Keywords
- hypoxia, exercise training, heart failure, cardiac remodeling
- Medical subject headings
- Heart Failure, Systolic, Hypoxia, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypoxia airOther
Normobaric hypoxia is generated by adding azote in normal air to decrease the oxygen availability.
| Study group | Role | What they receive |
|---|---|---|
| normoxia conditioning | Placebo comparator | exercise training in normoxia and rest conditioning in normoxia Receives: Other: hypoxia air |
| exercise hypoxia | Active comparator | exercise training in hypoxia and rest conditioning in normoxia Receives: Other: hypoxia air |
| rest hypoxia | Active comparator | exercise training in normoxia and rest conditioning in hypoxia Receives: Other: hypoxia air |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximal oxygen uptake in ml/min/kg
The maximal exercise capacity will be assessed by an incremental maximal bicycle exercise test
Measured: after 8 weeks of training and conditioning
Secondary outcomes (4)
End diastolic left ventricle diameter in mm
In parasternal long axe, the end diastolic left ventricle diameter
Measured: After 8 weeks of training and conditioning
systolic left ventricle ejection fraction in %
the systolic left ventricle ejection fraction will be assessed by Simpson's method in 4 and 2 cavity views
Measured: After 8 weeks of training and conditioning
flow mediated dilatation (FMD) in %
The rest FMD will be assessed by echocardiography by using the % of variation of the brachial artery diameter 10 minutes after occlusion.
Measured: After 8 weeks of training and conditioning
systolic and diastolic blood pressure control in mmHg
24 hours ambulatory blood pressure monitoring
Measured: After 8 weeks of training and conditioning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2018
- Study start5 Feb 2021
- Primary completion4 Dec 2023
- Study completion4 Dec 2023
Why it stopped: recruitment problem
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure, SystolicStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03537079
- Sponsor's protocol ID
- 38RC17.347
- Acronym
- hypoxheart
- Status last verified
- May 2026
- First submitted
- 26 Apr 2018
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypoxic Conditioning Combined With Exercise Training in Heart Failure Patient: a Randomised, Controled, Single Blind Study
- ClinicalTrials.gov ID
- NCT03537079
- Acronym / sponsor ID
- hypoxheart / 38RC17.347
- Conditions
- Heart Failure, Systolic
- Keywords
- hypoxia, exercise training, heart failure, cardiac remodeling
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment problem
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 5 Feb 2021 (actual)
- Primary completion
- 4 Dec 2023 (actual)
- Study completion
- 4 Dec 2023 (actual)
- First posted
- 25 May 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.
Heart failure impairs quality of life and exercise capacity, despite an optimal medical therapy. Alternative methods, like hypoxic conditioning coupled to exercise training, must be explored and describe
Detailed description
All heart failure patients will have a session of 45' of bicycle exercise training (in normoxia or hypoxia) AND a one hour rest session (in normoxia or hypoxia).
Exercise training sessions will consist in a continue bicycle exercise test at 70 to 80 % of the maximal heart rate, while breathing (single blind) normoxia or hypoxia gaz.
Rest conditioning consist in a one hour of rest, while breathing (single blind) normoxia or hypoxia gaz.
For hypoxia sessions, the oxygen saturation target will be fo 85-90 % for the 4 first weeks and 80-85 % for the last 4 weeks.
Three arms :
- exercise training in NORMOXIA and rest conditioning in NORMOXIA
- exercise training in HYPOXIA and rest conditioning in NORMOXIA
- exercise training in NORMOXIA and rest conditioning in HYPOXIA
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| normoxia conditioning | Placebo comparator | Other: hypoxia airexercise training in normoxia and rest conditioning in normoxia |
| exercise hypoxia | Active comparator | Other: hypoxia airexercise training in hypoxia and rest conditioning in normoxia |
| rest hypoxia | Active comparator | Other: hypoxia airexercise training in normoxia and rest conditioning in hypoxia |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patient available for exercise training
- stable heart failure state I-II New York Heart Association (NYHA) with altered ejection fraction (EF ≤ 40 %)
- signed informed consent
Key exclusion criteria (7 listed)
- unstable ischemic cardiopathy
- right ventricle dysfunction
- uncontrolled arrythmias
- rest elevated in pulmonary artery pressure (≥ 45 mmHg)
- migraine
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 |
|---|---|---|
| hypoxia airNormobaric hypoxia is generated by adding azote in normal air to decrease the oxygen availability. | Other | exercise hypoxia, normoxia conditioning, rest hypoxia |
Primary outcome
maximal oxygen uptake in ml/min/kg
Time frame: after 8 weeks of training and conditioning
The maximal exercise capacity will be assessed by an incremental maximal bicycle exercise test
4 secondary outcomes
End diastolic left ventricle diameter in mm
Time frame: After 8 weeks of training and conditioning
systolic left ventricle ejection fraction in %
Time frame: After 8 weeks of training and conditioning
flow mediated dilatation (FMD) in %
Time frame: After 8 weeks of training and conditioning
systolic and diastolic blood pressure control in mmHg
Time frame: After 8 weeks of training and conditioning
Results and safety
The study was stopped early (reason given: recruitment problem). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hypoxia air in people with Heart Failure, Systolic, run by University Hospital, Grenoble at 1 site in France.
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 3 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: stopped early, as of the sponsor's last update on 8 May 2026. 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 France. 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 was stopped early (reason given: recruitment problem). Results are not available in the source record.
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?
maximal oxygen uptake in ml/min/kg (time frame: after 8 weeks of training and conditioning). 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 8 May 2026.