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Hypoxic Conditioning in Heart Failure

Hypoxic Conditioning Combined With Exercise Training in Heart Failure Patient: a Randomised, Controled, Single Blind Study

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03537079
Acronym
hypoxheart
Enrollment
14
Registered
2018-05-25
Start date
2021-02-05
Completion date
2023-12-04
Last updated
2026-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Systolic

Keywords

hypoxia, exercise training, heart failure, cardiac remodeling

Brief 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

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

Interventions

OTHERhypoxia air

Normobaric hypoxia is generated by adding azote in normal air to decrease the oxygen availability.

Sponsors

University Hospital, Grenoble
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

this is a single blind study patients don't know if they are breathing normal air (normoxia) or hypoxic air (hypoxia).

Eligibility

Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
maximal oxygen uptake in ml/min/kgafter 8 weeks of training and conditioningThe maximal exercise capacity will be assessed by an incremental maximal bicycle exercise test

Secondary

MeasureTime frameDescription
End diastolic left ventricle diameter in mmAfter 8 weeks of training and conditioningIn parasternal long axe, the end diastolic left ventricle diameter
systolic left ventricle ejection fraction in %After 8 weeks of training and conditioningthe systolic left ventricle ejection fraction will be assessed by Simpson's method in 4 and 2 cavity views
flow mediated dilatation (FMD) in %After 8 weeks of training and conditioningThe rest FMD will be assessed by echocardiography by using the % of variation of the brachial artery diameter 10 minutes after occlusion.
systolic and diastolic blood pressure control in mmHgAfter 8 weeks of training and conditioning24 hours ambulatory blood pressure monitoring

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 9, 2026