- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03537079
Hypoxic Conditioning in Heart Failure (hypoxheart)
Hypoxic Conditioning Combined With Exercise Training in Heart Failure Patient: a Randomised, Controled, Single Blind Study
Study Overview
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: stephane doutreleau, MD, PhD
- Phone Number: + 33 4 76 76 77 73
- Email: sdoutreleau@chu-grenoble.fr
Study Contact Backup
- Name: samuel verges, PhD
- Phone Number: + 33 4 76 76 54 94
- Email: sverges@chu-grenoble.fr
Study Locations
-
-
-
Grenoble, France, 38000
- Recruiting
- University Hospital
-
Contact:
- samuel verges, PhD
- Phone Number: + 33 4 76 76 54 94
- Email: sverges@chu-grenoble.fr
-
Contact:
- stephane doutreleau, MD, PhD
- Phone Number: +33 4 76 76 77 73
- Email: sdoutreleau@chu-grenoble.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: normoxia conditioning
exercise training in normoxia and rest conditioning in normoxia
|
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
|
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
|
Normobaric hypoxia is generated by adding azote in normal air to decrease the oxygen availability.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
maximal oxygen uptake in ml/min/kg
Time Frame: after 8 weeks of training and conditioning
|
The maximal exercise capacity will be assessed by an incremental maximal bicycle exercise test
|
after 8 weeks of training and conditioning
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
End diastolic left ventricle diameter in mm
Time Frame: After 8 weeks of training and conditioning
|
In parasternal long axe, the end diastolic left ventricle diameter
|
After 8 weeks of training and conditioning
|
systolic left ventricle ejection fraction in %
Time Frame: 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
|
After 8 weeks of training and conditioning
|
flow mediated dilatation (FMD) in %
Time Frame: 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.
|
After 8 weeks of training and conditioning
|
systolic and diastolic blood pressure control in mmHg
Time Frame: After 8 weeks of training and conditioning
|
24 hours ambulatory blood pressure monitoring
|
After 8 weeks of training and conditioning
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 38RC17.347
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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