Hypoxic Conditioning in Heart Failure

Heart Failure, Systolic Clinical Trial

— hypoxheart  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03537079
• Other study ID #: 38RC17.347
• Status: Recruiting
• Phase: N/A
• Start date: May 2020
• Est. completion date: May 2022

Study information

• Verified date: March 2020
• Source: University Hospital, Grenoble
• Contact: stephane doutreleau, MD, PhD
• Phone: + 33 4 76 76 77 73
• Email: sdoutreleau[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 63
• Est. completion date: May 2022
• Est. primary completion date: May 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Systolic

Intervention

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

Locations

Country	Name	City	State
France	University Hospital	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	End diastolic left ventricle diameter in mm	In parasternal long axe, the end diastolic left ventricle diameter	After 8 weeks of training and conditioning
Secondary	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
Secondary	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
Secondary	systolic and diastolic blood pressure control in mmHg	24 hours ambulatory blood pressure monitoring	After 8 weeks of training and conditioning