Hypoxic Conditioning in Heart Failure

Not Applicable

• Conditions: Heart Failure, Systolic
• Interventions: Other: hypoxia air

• Registration Number: NCT03537079
• Lead Sponsor: University Hospital, Grenoble

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

Study Timeline

• Study First Submitted: 2018-04-26
• Study First Submitted QC: 2018-05-14
• Study First Posted: 2018-05-25
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-24
• Last Update Posted: 2020-03-25
• Study Start: 2020-05
• Primary Completion: 2021-05
• Study Completion: 2022-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 63

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
normoxia conditioning	hypoxia air	exercise training in normoxia and rest conditioning in normoxia
rest hypoxia	hypoxia air	exercise training in normoxia and rest conditioning in hypoxia
exercise hypoxia	hypoxia air	exercise training in hypoxia and rest conditioning in normoxia

Primary Outcome Measures

Name	Time	Method
maximal oxygen uptake in ml/min/kg	after 8 weeks of training and conditioning	The maximal exercise capacity will be assessed by an incremental maximal bicycle exercise test

Secondary Outcome Measures

Name	Time	Method
End diastolic left ventricle diameter in mm	After 8 weeks of training and conditioning	In parasternal long axe, the end diastolic left ventricle diameter
systolic left ventricle ejection fraction in %	After 8 weeks of training and conditioning	the 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 conditioning	The 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 mmHg	After 8 weeks of training and conditioning	24 hours ambulatory blood pressure monitoring

Trial Locations

Locations (1)

University Hospital; 🇫🇷 Grenoble, France