Hypoxic Conditioning in Heart Failure (hypoxheart)
Primary Purpose
Heart Failure, Systolic
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
hypoxia air
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure, Systolic focused on measuring hypoxia, exercise training, heart failure, cardiac remodeling
Eligibility Criteria
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
Sites / Locations
- University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
normoxia conditioning
exercise hypoxia
rest hypoxia
Arm Description
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
Outcomes
Primary Outcome Measures
maximal oxygen uptake in ml/min/kg
The maximal exercise capacity will be assessed by an incremental maximal bicycle exercise test
Secondary Outcome Measures
End diastolic left ventricle diameter in mm
In parasternal long axe, the end diastolic left ventricle diameter
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
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.
systolic and diastolic blood pressure control in mmHg
24 hours ambulatory blood pressure monitoring
Full Information
NCT ID
NCT03537079
First Posted
April 26, 2018
Last Updated
March 24, 2020
Sponsor
University Hospital, Grenoble
1. Study Identification
Unique Protocol Identification Number
NCT03537079
Brief Title
Hypoxic Conditioning in Heart Failure
Acronym
hypoxheart
Official Title
Hypoxic Conditioning Combined With Exercise Training in Heart Failure Patient: a Randomised, Controled, Single Blind Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 2020 (Anticipated)
Primary Completion Date
May 2021 (Anticipated)
Study Completion Date
May 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Systolic
Keywords
hypoxia, exercise training, heart failure, cardiac remodeling
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
this is a single blind study patients don't know if they are breathing normal air (normoxia) or hypoxic air (hypoxia).
Allocation
Randomized
Enrollment
63 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
normoxia conditioning
Arm Type
Placebo Comparator
Arm Description
exercise training in normoxia and rest conditioning in normoxia
Arm Title
exercise hypoxia
Arm Type
Active Comparator
Arm Description
exercise training in hypoxia and rest conditioning in normoxia
Arm Title
rest hypoxia
Arm Type
Active Comparator
Arm Description
exercise training in normoxia and rest conditioning in hypoxia
Intervention Type
Other
Intervention Name(s)
hypoxia air
Intervention Description
Normobaric hypoxia is generated by adding azote in normal air to decrease the oxygen availability.
Primary Outcome Measure Information:
Title
maximal oxygen uptake in ml/min/kg
Description
The maximal exercise capacity will be assessed by an incremental maximal bicycle exercise test
Time Frame
after 8 weeks of training and conditioning
Secondary Outcome Measure Information:
Title
End diastolic left ventricle diameter in mm
Description
In parasternal long axe, the end diastolic left ventricle diameter
Time Frame
After 8 weeks of training and conditioning
Title
systolic left ventricle ejection fraction in %
Description
the systolic left ventricle ejection fraction will be assessed by Simpson's method in 4 and 2 cavity views
Time Frame
After 8 weeks of training and conditioning
Title
flow mediated dilatation (FMD) in %
Description
The rest FMD will be assessed by echocardiography by using the % of variation of the brachial artery diameter 10 minutes after occlusion.
Time Frame
After 8 weeks of training and conditioning
Title
systolic and diastolic blood pressure control in mmHg
Description
24 hours ambulatory blood pressure monitoring
Time Frame
After 8 weeks of training and conditioning
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
stephane doutreleau, MD, PhD
Phone
+ 33 4 76 76 77 73
Email
sdoutreleau@chu-grenoble.fr
First Name & Middle Initial & Last Name or Official Title & Degree
samuel verges, PhD
Phone
+ 33 4 76 76 54 94
Email
sverges@chu-grenoble.fr
Facility Information:
Facility Name
University Hospital
City
Grenoble
ZIP/Postal Code
38000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
stephane doutreleau, MD, PhD
Phone
+33 4 76 76 77 73
Email
sdoutreleau@chu-grenoble.fr
First Name & Middle Initial & Last Name & Degree
samuel verges, PhD
Phone
+ 33 4 76 76 54 94
Email
sverges@chu-grenoble.fr
12. IPD Sharing Statement
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Hypoxic Conditioning in Heart Failure
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