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Hypoxic Conditioning in Heart Failure (hypoxheart)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03537079
Recruitment Status : Recruiting
First Posted : May 25, 2018
Last Update Posted : March 25, 2020
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Heart Failure, Systolic Other: hypoxia air Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : May 2020
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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.

  4. systolic and diastolic blood pressure control in mmHg [ Time Frame: After 8 weeks of training and conditioning ]
    24 hours ambulatory blood pressure monitoring



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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03537079


Contacts
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Contact: stephane doutreleau, MD, PhD + 33 4 76 76 77 73 sdoutreleau@chu-grenoble.fr
Contact: samuel verges, PhD + 33 4 76 76 54 94 sverges@chu-grenoble.fr

Locations
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France
University Hospital Recruiting
Grenoble, France, 38000
Contact: stephane doutreleau, MD, PhD    +33 4 76 76 77 73    sdoutreleau@chu-grenoble.fr   
Contact: samuel verges, PhD    + 33 4 76 76 54 94    sverges@chu-grenoble.fr   
Sponsors and Collaborators
University Hospital, Grenoble
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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT03537079    
Other Study ID Numbers: 38RC17.347
First Posted: May 25, 2018    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Grenoble:
hypoxia
exercise training
heart failure
cardiac remodeling
Additional relevant MeSH terms:
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Heart Failure
Heart Failure, Systolic
Heart Diseases
Cardiovascular Diseases