Hypoxic Conditioning in Heart Failure

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Heart Failure, Systolic

Intervention / Treatment
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* Other: hypoxia air


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: normoxia conditioning<br>exercise training in normoxia and rest conditioning in normoxia | Other: hypoxia air<br>* Normobaric hypoxia is generated by adding azote in normal air to decrease the oxygen availability.<br>|
| Active Comparator: exercise hypoxia<br>exercise training in hypoxia and rest conditioning in normoxia | Other: hypoxia air<br>* Normobaric hypoxia is generated by adding azote in normal air to decrease the oxygen availability.<br>|
| Active Comparator: rest hypoxia<br>exercise training in normoxia and rest conditioning in hypoxia | Other: hypoxia air<br>* Normobaric hypoxia is generated by adding azote in normal air to decrease the oxygen availability.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maximal oxygen uptake in ml/min/kg | The maximal exercise capacity will be assessed by an incremental maximal bicycle exercise test | after 8 weeks of training and conditioning | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| End diastolic left ventricle diameter in mm | In parasternal long axe, the end diastolic left ventricle diameter | 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 | 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. | After 8 weeks of training and conditioning | 
| systolic and diastolic blood pressure control in mmHg | 24 hours ambulatory blood pressure monitoring | After 8 weeks of training and conditioning | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac remodeling, hypoxia, exercise training, heart failure