Hypoxic Conditioning in Heart Failure (hypoxheart)

March 24, 2020 updated by: University Hospital, Grenoble

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

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

Study Overview

Status

Unknown

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

63

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2020

Primary Completion (Anticipated)

May 1, 2021

Study Completion (Anticipated)

May 1, 2022

Study Registration Dates

First Submitted

April 26, 2018

First Submitted That Met QC Criteria

May 14, 2018

First Posted (Actual)

May 25, 2018

Study Record Updates

Last Update Posted (Actual)

March 25, 2020

Last Update Submitted That Met QC Criteria

March 24, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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