Hypoxic Conditioning in Heart Failure

NCT03537079 | Terminated DMC

• 1 other identifier: 38RC17.347
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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

Conditions

Heart Failure, Systolic

Keywords

hypoxia; exercise training; heart failure; cardiac remodeling

Outcome Measures

Primary Outcomes (1)

• maximal oxygen uptake in ml/min/kg

  The maximal exercise capacity will be assessed by an incremental maximal bicycle exercise test

  after 8 weeks of training and conditioning

Secondary Outcomes (4)

• End diastolic left ventricle diameter in mm

  After 8 weeks of training and conditioning

• systolic left ventricle ejection fraction in %

  After 8 weeks of training and conditioning

• flow mediated dilatation (FMD) in %

  After 8 weeks of training and conditioning

• systolic and diastolic blood pressure control in mmHg

  After 8 weeks of training and conditioning

Study Arms (3)

normoxia conditioning

PLACEBO COMPARATOR

exercise training in normoxia and rest conditioning in normoxia

Other: hypoxia air

exercise hypoxia

ACTIVE COMPARATOR

exercise training in hypoxia and rest conditioning in normoxia

Other: hypoxia air

rest hypoxia

ACTIVE COMPARATOR

exercise training in normoxia and rest conditioning in hypoxia

Other: hypoxia air

Interventions

hypoxia air OTHER

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

exercise hypoxia; normoxia conditioning; rest hypoxia

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

University Hospital

Grenoble, 38000, France

Location

MeSH Terms

Conditions

Heart Failure, Systolic; Hypoxia; Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: this is a single blind study patients don't know if they are breathing normal air (normoxia) or hypoxic air (hypoxia).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2018
• First Posted: May 25, 2018
• Study Start: February 5, 2021
• Primary Completion: December 4, 2023
• Study Completion: December 4, 2023
• Last Updated: May 8, 2026

Record last verified: 2026-05

Locations

FR (1)