Comparing two breathing support treatments in people with chronic heart failure

Trial details

Who runs it

University Hospital, Rouen

Trial code

NCT04471129

Record updated

16 March 2026

Original description

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 full original descriptionShow less

Non-invasive Ventilation and High-speed Oxygen Therapy Effects on Heart Function - HiFlow-Heart 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.

Inclusion: 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; 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.

Exclusion: Acute respiratory failure as defined by :; clinical signs: respiratory rate >35/min, signs of struggle, SpO2<92% on O2C; 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 treatment with NIV or CPAP at home; Administration of loop diuretics within 3 hours prior to inclusion for intravenous forms and within 6 hours for oral forms; 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); Chronic advanced respiratory disease; Non-operated aortic or mitral insufficiency ≥ II/IV; Contraindication to the use of NIV or HFO; Patient with orotracheal intubation or tracheotomy; 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.

ClinicalTrials.gov NCT04471129