Hypoxic Conditioning in Heart Failure

NCT ID: NCT03537079

Last Updated: 2020-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-31

Study Completion Date

2022-05-31

Brief Summary

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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

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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

Conditions

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Heart Failure, Systolic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

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

Study Groups

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normoxia conditioning

exercise training in normoxia and rest conditioning in normoxia

Group Type PLACEBO_COMPARATOR

hypoxia air

Intervention Type OTHER

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

exercise hypoxia

exercise training in hypoxia and rest conditioning in normoxia

Group Type ACTIVE_COMPARATOR

hypoxia air

Intervention Type OTHER

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

rest hypoxia

exercise training in normoxia and rest conditioning in hypoxia

Group Type ACTIVE_COMPARATOR

hypoxia air

Intervention Type OTHER

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

Interventions

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hypoxia air

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospital

Grenoble, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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stephane doutreleau, MD, PhD

Role: CONTACT

+ 33 4 76 76 77 73

samuel verges, PhD

Role: CONTACT

+ 33 4 76 76 54 94

Facility Contacts

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stephane doutreleau, MD, PhD

Role: primary

+33 4 76 76 77 73

samuel verges, PhD

Role: backup

+ 33 4 76 76 54 94

Other Identifiers

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38RC17.347

Identifier Type: -

Identifier Source: org_study_id

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