hypoxheart: Hypoxic Conditioning in Heart Failure

Sponsor

University Hospital, Grenoble (Other)

Overall Status

Unknown status

CT.gov ID

NCT03537079

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Heart Failure, Systolic	Other: hypoxia air	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

63 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Masking Description:

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

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

May 1, 2020

Anticipated Primary Completion Date :

May 1, 2021

Anticipated Study Completion Date :

May 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: normoxia conditioning exercise training in normoxia and rest conditioning in normoxia	Other: hypoxia air Normobaric hypoxia is generated by adding azote in normal air to decrease the oxygen availability.
Active Comparator: exercise hypoxia exercise training in hypoxia and rest conditioning in normoxia	Other: hypoxia air Normobaric hypoxia is generated by adding azote in normal air to decrease the oxygen availability.
Active Comparator: rest hypoxia exercise training in normoxia and rest conditioning in hypoxia	Other: hypoxia air Normobaric hypoxia is generated by adding azote in normal air to decrease the oxygen availability.

Arm

Intervention/Treatment

Placebo Comparator: normoxia conditioning

exercise training in normoxia and rest conditioning in normoxia

Other: hypoxia air

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

Active Comparator: exercise hypoxia

exercise training in hypoxia and rest conditioning in normoxia

Other: hypoxia air

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

Active Comparator: rest hypoxia

exercise training in normoxia and rest conditioning in hypoxia

Other: hypoxia air

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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