Chronic Heart FailureHiFlow-HeartNCT04471129
Non-invasive Ventilation and High-speed Oxygen Therapy Effects on Heart Function - HiFlow-Heart Study
A study testing HFO/O2C/NIV and NIV/O2C/HFO in people with Chronic Heart Failure, run by University Hospital, Rouen at 1 site in France.
Trial summary
The investigators hypothesize that the airway pressures generated by High Flow Oxygen Therapy could have a beneficial impact in patients with heart failure, particularly by lowering capillary pulmonary arterial pressures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- HFO/O2C/NIV and NIV/O2C/HFO
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 16 Sep 2020to 16 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major patient
- Patient who has undergone cardiac surgery with extracorporeal circulation for more than 24 hours and has been extubated for at least 6 hours.
- Pre-operative heart failure with left ventricular ejection fraction < 40%.
- Invasive monitoring by pulmonary arterial catheter (Swan-Ganz) with transpulmonary thermodilution and by radial arterial catheter intended for use in the intra- and post-operative monitoring of the patient.
- Treatment with conventional oxygen therapy (O2C) without an increase in O2 flow for more than 30 minuts, without signs of hypoxemia (SpO292%)
- Stable hemodynamic parameters: no changes in hemodynamic parameters (arterial pressures and pulmonary and cardiac index) by more than 10% over the 30 minutes prior to inclusion and no increase in cardiotropic medication for at least 30 minutes.
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- Patient with an oxygenation rate ≤ 6L
- For women of child-bearing age: negative pregnancy test at inclusion
- Person who has read and understood the information letter and signed the consent form
- Affiliation to a social security scheme
Who cannot join
- Contraindication to the use of NIV or HFO
- Patient with orotracheal intubation or tracheotomy
- Renal failure with hemodialysis or hemofiltration
- Uncontrolled state of shock (PAS<90 mmHg and/or cardiac index<1.8 L/min/m² and/or norepinephrine>0.2 μg/kg/min and/or dobutamine>10 μg/kg/min)
- Acute respiratory failure as defined by :
- clinical signs: respiratory rate >35/min, signs of struggle, SpO2<92% on O2C
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- indication for treatment with NIV or HFO at the discretion of the clinician
- oxygen dependency requiring O2C>6L/min O2C flow at the oxygen mask
- Chronic advanced respiratory disease
- Chronic treatment with NIV or CPAP at home
- Non-operated aortic or mitral insufficiency ≥ II/IV
- Administration of loop diuretics within 3 hours prior to inclusion for intravenous forms and within 6 hours for oral forms.
- Presence of altered consciousness defined by a Glasgow score < 15/15 or cognitive dysfunction defined by a CAM-ICU score > 0/4
- Pregnant or parturient or nursing woman or proven lack of effective contraception
- Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection / subtutorship or guardianship
- Person participating in another trial / having participated in another trial that may interfere with the procedures that are the subject of the research within a 4-week time frame
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Chu Rouen
Rouen, 76031
Emmanuel Besnier, Dr, 02 32 88 17 05, Emmanuel.Besnier@chu-rouen.fr
Emmanuel Besnier, Dr
About this study
The investigators hypothesize that the airway pressures generated by High Flow Oxygen Therapy could have a beneficial impact in patients with heart failure, particularly by lowering capillary pulmonary arterial pressures. However, results compared to Non-Invasive Ventilation are difficult to predict due to the lack of data in the literature.
Read the detailed description
The investigators propose to carry out a prospective randomized cross-over prospective physiological study comparing, Non-Invasive Ventilation and High Flow Oxygen Therapy in patients with chronic uncompensated heart failure. This stable population would make it possible to easily study variations in a physiological parameter without any added risk for the patient, but with all the pathophysiological parameters transposable to the situation of decompensated heart failure.
Indeed, it is accepted that the existence of heart failure with decreased left ventricular ejection fraction (LVEF) (< 40%) exposes patients to a high risk of congestive cardiac decompensation due to the associated presence of diastolic dysfunction1.
The study will be conducted using an alternating design, where a patient receives the two treatments one after the other ("cross-over"), because the alternating design, compared to the two parallel arm design, reduces the number of patients needed to show a given difference between High Flow Oxygen Therapy and Non-Invasive Ventilation at equal power, if there is neither an order-of-prescription effect ("period") nor a residual effect of the first treatment on the second treatment ("carry-over"). In order to avoid a residual effect on changes in pressure or oxygenation, a wash-out period on conventional oxygen therapy (O2C) should be set between the two treatments (High Flow Oxygen Therapy and Non-Invasive Ventilation) administered to the same patient.
- Conditions
- Chronic Heart Failure
- Being tested
- HFO/O2C/NIV, NIV/O2C/HFO
- Keywords
- chronic heart failure, heart surgery, invasive mechanical ventilation, high flow oxygen therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HFO/O2C/NIVOther
High-flow oxygen therapy + O2C + Non invasive ventilation
NIV/O2C/HFOOther
Non invasive ventilation + O2C + High-flow oxygen therapy
| Study group | Role | What they receive |
|---|---|---|
| High-Flow Oxygen Therapy, followed by Non-Invasive Ventilation | Other | oxygenation first by High-Flow Oxygen Therapy, then by O2C, then by Non-Invasive Ventilation Receives: Other: HFO/O2C/NIV |
| Non-Invasive Ventilation, followed by High-Flow Oxygen Therapy | Other | oxygenation first by Non-Invasive Ventilation, then by O2C, then by High-Flow Oxygen Therapy Receives: Other: NIV/O2C/HFO |
What is being measured
The primary outcome is the main question the study is designed to answer.
High-Flow Oxygen Therapy and Non Invasive Ventilation on left ventricular filling pressures
Difference between High-Flow Oxygen Therapy and Non Invasive Ventilation on left ventricular filling pressures as assessed by the occluded pulmonary artery occlusion pressure (in mmHg) measured by Swan-Ganz pulmonary artery catheterization
Measured: Day 1
Secondary outcomes (4)
Comparison between High-Flow Oxygen Therapy and Non-Invasive ventilation w.r.t. ventricular function
Arterial pressure [mmHg] measured by Swan-Ganz catheter
Measured: Day 1
Comparison between High-Flow Oxygen Therapy and Non-Invasive ventilation w.r.t. arterial oxygenation
Arterial oxygen saturation, SaO2 [%], measured by Swan-Ganz catheter
Measured: Day 1
Comparison between High-Flow Oxygen Therapy and Non-Invasive ventilation w.r.t. change in pulmonary volume
End-expiratory lung impedance (mean of 3 measures), measured by PulmoVista (Draeger, Germany)
Measured: Day 1
Patient comfort
Patient's evaluation of comfort on Visual Analog Scale (10 points)
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start16 Sep 2020
- Primary completion16 Sep 2026 (estimated)
- Study completion16 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- sequential assignment
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04471129
- Sponsor's protocol ID
- 2019/0400/HP
- Acronym
- HiFlow-Heart
- Status last verified
- Mar 2026
- First submitted
- 25 Jun 2020
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Ventilation and High-speed Oxygen Therapy Effects on Heart Function - HiFlow-Heart Study
- ClinicalTrials.gov ID
- NCT04471129
- Acronym / sponsor ID
- HiFlow-Heart / 2019/0400/HP
- Conditions
- Chronic Heart Failure
- Keywords
- chronic heart failure, heart surgery, invasive mechanical ventilation, high flow oxygen therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 16 Sep 2020 (actual)
- Primary completion
- 16 Sep 2026 (estimated)
- Study completion
- 16 Sep 2026 (estimated)
- First posted
- 15 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators hypothesize that the airway pressures generated by High Flow Oxygen Therapy could have a beneficial impact in patients with heart failure, particularly by lowering capillary pulmonary arterial pressures. However, results compared to Non-Invasive Ventilation are difficult to predict due to the lack of data in the literature.
Detailed description
The investigators propose to carry out a prospective randomized cross-over prospective physiological study comparing, Non-Invasive Ventilation and High Flow Oxygen Therapy in patients with chronic uncompensated heart failure. This stable population would make it possible to easily study variations in a physiological parameter without any added risk for the patient, but with all the pathophysiological parameters transposable to the situation of decompensated heart failure.
Indeed, it is accepted that the existence of heart failure with decreased left ventricular ejection fraction (LVEF) (< 40%) exposes patients to a high risk of congestive cardiac decompensation due to the associated presence of diastolic dysfunction1.
The study will be conducted using an alternating design, where a patient receives the two treatments one after the other ("cross-over"), because the alternating design, compared to the two parallel arm design, reduces the number of patients needed to show a given difference between High Flow Oxygen Therapy and Non-Invasive Ventilation at equal power, if there is neither an order-of-prescription effect ("period") nor a residual effect of the first treatment on the second treatment ("carry-over"). In order to avoid a residual effect on changes in pressure or oxygenation, a wash-out period on conventional oxygen therapy (O2C) should be set between the two treatments (High Flow Oxygen Therapy and Non-Invasive Ventilation) administered to the same patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- sequential assignment
| Arm | Type | Receives |
|---|---|---|
| High-Flow Oxygen Therapy, followed by Non-Invasive Ventilation | Other | Other: HFO/O2C/NIVoxygenation first by High-Flow Oxygen Therapy, then by O2C, then by Non-Invasive Ventilation |
| Non-Invasive Ventilation, followed by High-Flow Oxygen Therapy | Other | Other: NIV/O2C/HFOoxygenation first by Non-Invasive Ventilation, then by O2C, then by High-Flow Oxygen Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Major patient
- Patient who has undergone cardiac surgery with extracorporeal circulation for more than 24 hours and has been extubated for at least 6 hours.
- Pre-operative heart failure with left ventricular ejection fraction < 40%.
- Invasive monitoring by pulmonary arterial catheter (Swan-Ganz) with transpulmonary thermodilution and by radial arterial catheter intended for use in the intra- and post-operative monitoring of the patient.
- Treatment with conventional oxygen therapy (O2C) without an increase in O2 flow for more than 30 minuts, without signs of hypoxemia (SpO292%)
Key exclusion criteria (16 listed)
- Contraindication to the use of NIV or HFO
- Patient with orotracheal intubation or tracheotomy
- Renal failure with hemodialysis or hemofiltration
- Uncontrolled state of shock (PAS<90 mmHg and/or cardiac index<1.8 L/min/m² and/or norepinephrine>0.2 μg/kg/min and/or dobutamine>10 μg/kg/min)
- Acute respiratory failure as defined by :
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HFO/O2C/NIVHigh-flow oxygen therapy + O2C + Non invasive ventilation | Other | High-Flow Oxygen Therapy, followed by Non-Invasive Ventilation |
| NIV/O2C/HFONon invasive ventilation + O2C + High-flow oxygen therapy | Other | Non-Invasive Ventilation, followed by High-Flow Oxygen Therapy |
Primary outcome
High-Flow Oxygen Therapy and Non Invasive Ventilation on left ventricular filling pressures
Time frame: Day 1
Difference between High-Flow Oxygen Therapy and Non Invasive Ventilation on left ventricular filling pressures as assessed by the occluded pulmonary artery occlusion pressure (in mmHg) measured by Swan-Ganz pulmonary artery catheterization
4 secondary outcomes
Comparison between High-Flow Oxygen Therapy and Non-Invasive ventilation w.r.t. ventricular function
Time frame: Day 1
Comparison between High-Flow Oxygen Therapy and Non-Invasive ventilation w.r.t. arterial oxygenation
Time frame: Day 1
Comparison between High-Flow Oxygen Therapy and Non-Invasive ventilation w.r.t. change in pulmonary volume
Time frame: Day 1
Patient comfort
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HFO/O2C/NIV and NIV/O2C/HFO in people with Chronic Heart Failure, run by University Hospital, Rouen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elisabeth Surlemont, Dr (+33232881705, Elisabeth.Surlemont@chu-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
High-Flow Oxygen Therapy and Non Invasive Ventilation on left ventricular filling pressures (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.