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recruitment problem
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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
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 :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| normoxia conditioning | Placebo Comparator | exercise training in normoxia and rest conditioning in normoxia |
|
| exercise hypoxia | Active Comparator | exercise training in hypoxia and rest conditioning in normoxia |
|
| rest hypoxia | Active Comparator | exercise training in normoxia and rest conditioning in hypoxia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hypoxia air | Other | Normobaric hypoxia is generated by adding azote in normal air to decrease the oxygen availability. |
|
| 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 |
| 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 % |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Grenoble | 38000 | France |
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| ID | Term |
|---|---|
| D054143 | Heart Failure, Systolic |
| D000860 | Hypoxia |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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this is a single blind study patients don't know if they are breathing normal air (normoxia) or hypoxic air (hypoxia).
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 |
| D013568 | Pathological Conditions, Signs and Symptoms |