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RecruitingNCT05989139HFvsNIVUpdated Aug 15, 2025

HF vs NIV in Acute Cardiogenic Pulmonary Edema

An interventional study of NPPV/HFNC and HFNC/NPPV in Pulmonary Edema Cardiac Cause, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-15.

Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jan 2024; still recruiting 2 years 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The study's primary aim is

  • to compare the effects of two different ventilation modalities, non-invasive positive-pressure ventilation (NPPV) and high-flow nasal cannulae (HFNC), in the acute cardiogenic pulmonary edema (ACPE) setting, in terms of echocardiographic parameters of RV systolic and RV strain.
  • to determine the differences of the two interventions on other hemodynamic parameters echocardiographically assessed.
  • to assess the differences between the two interventions on physiological parameters, i.e., mean arterial pressure (MAP), heart rate (HR), respiratory rate (RR), oxygen saturation (SpO2), and on arterial blood gases (ABG) analysis parameters (i.e. relief of dyspnea and respiratory distress, patient comfort).

Enrolled patients will receive NPPV and HFNC oxygen therapy in a randomized, cross-over fashion, for 40 minutes each (time 0, T0 and time 1, T1), followed by clinical and echocardiographic evaluation

02

Conditions studied

  • Pulmonary Edema Cardiac Cause

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03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's planned enrollment of 30 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 920 studies on the registry; 529 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age ≥ 18 y.o.;
  • Clinical diagnosis of ACPE in the setting of either AMI, acute myocarditis, acute/chronic severe mitral/aortic valve regurgitation, severe mitral/aortic stenosis, acute/chronic HF with rLVEF diagnosed according to European Society of Cardiology (ESC) guidelines [4];
  • Hypertensive crisis with systolic blood pressure >200 mmHg;
  • Other congenital or acquired structural heart disease causing post capillary pulmonary hypertension or combination of the previous.
  • Written informed consent.

Exclusion criteria

Exclusion Criteria:

  • Age \<18 y.o.;
  • Hypercapnia with respiratory acidosis (PaCO2 > 45 mmHg with pH \< 7.35);
  • History of fever in the previous 4 days;
  • White blood cell count > 12.000;
  • Increased procalcitonin serum levels;
  • Consolidative areas at chest radiograph;
  • Hypotension (systolic blood pressure \< 85 mmHg);
  • Cardiogenic shock;
  • Right ventricular (RV) dysfunction;
  • Previous cardiac surgery,
  • Glasgow Coma Scale score ≤ 8 points;
  • Impaired ability to protect the airway from aspiration;
  • Orotracheal intubation needed due to cardiopulmonary resuscitation maneuvers;
  • Respiratory arrest;
  • Severe hemodynamic instability;
  • Facial trauma, burns, recent facial surgery or facial anatomy which prevents from the application of the NPPV interface to patient's face.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    NPPV

    non-invasive positive-pressure ventilation arm

    Procedure: NPPV/HFNC

  • Experimental
    HFNC

    High-flow nasal cannulae arm

    Procedure: HFNC/NPPV

Interventions

  • ProcedureNPPV/HFNC

    Enrolled patients will receive NPPV and HFNC oxygen therapy in a randomized, cross-over fashion, for 40 minutes each. NPPV will be delivered through a full-face mask with a FiO2 starting at 100% and then titrated to achieve an SpO2 of 92-98%. Expiratory positive airway pressure (PEEP) will be firstly set to 5 cmH2O and then increased to a maximum of 15 cmH2O based on SpO2. Pressure support (PS) will be set to an initial value of 10 cmH2O and then increased if signs of respiratory distress persisted or worsened to a maximum value of 20 cmH2O. After 40 minutes, patient is shifted to HFNC ventilation support for 40 minutes. At the end of the protocol, the patient will receive the treatment that will be shown as more appropriate for the patient, according to the attending physician, who will be informed about the results of the study on the individual patient.

  • ProcedureHFNC/NPPV

    Enrolled patients will receive NPPV and HFNC oxygen therapy in a randomized, cross-over fashion, for 40 minutes each. HFNC oxygen therapy will start at a flow rate of 60 L/min and will be gradually decreased by 5 cmH2O at time if the patient experienced discomfort. FiO2 will be started at 100% and then titrated to maintain a peripheral oxygen saturation of 92%-98%. Active heating and humidification were provided using MR850, Fisher and Paykel, with a temperature chamber of 37°C. After 40 minutes, patient is shifted to NPPV ventilation support for 40 minutes At the end of the protocol, the patient will receive the treatment that will be shown as more appropriate for the patient, according to the attending physician, who will be informed about the results of the study on the individual patient.

06

What researchers measure

Primary outcomes

  1. RV systolic function: Tricuspid annular plane systolic excursion (TAPSE), mm

    Tricuspid annular plane systolic excursion (TAPSE) is a parameter of global RV function which describes apex-to-base shortening. Normal value \> 16 mm.

    Time frame: T0 (Patient's enrollment time)

  2. RV systolic function: Tricuspid annular plane systolic excursion (TAPSE), mm

    Tricuspid annular plane systolic excursion (TAPSE) is a parameter of global RV function which describes apex-to-base shortening. Normal value \> 16 mm.

    Time frame: T1 (40 minutes after the first intervention has started)

  3. RV systolic function: Tricuspid annular plane systolic excursion (TAPSE), mm

    Tricuspid annular plane systolic excursion (TAPSE) is a parameter of global RV function which describes apex-to-base shortening. Normal value \> 16 mm.

    Time frame: T2 (40 minutes after the second intervention has started)

  4. RV systolic function: RV fractional area change (RVFAC), %

    RV fractional area change (RVFAC) is a parameter of radial RV function. It is calculated, in apical four chambers view, as the difference between end-diastolic and end-systolic RV area divided by the end-diastolic area and multiplied by 100. Normal value \> 35%.

    Time frame: T0 (Patient's enrollment time)

  5. RV systolic function: RV fractional area change (RVFAC), %

    RV fractional area change (RVFAC) is a parameter of radial RV function. It is calculated, in apical four chambers view, as the difference between end-diastolic and end-systolic RV area divided by the end-diastolic area and multiplied by 100. Normal value \> 35%.

    Time frame: T1 (40 minutes after the first intervention has started)

  6. RV systolic function: RV fractional area change (RVFAC), %

    RV fractional area change (RVFAC) is a parameter of radial RV function. It is calculated, in apical four chambers view, as the difference between end-diastolic and end-systolic RV area divided by the end-diastolic area and multiplied by 100. Normal value \> 35%.

    Time frame: T2 (40 minutes after the second intervention has started)

  7. RV systolic function: RV Global Longitudinal strain (GLS), %

    RV Global Longitudinal strain (GLS) is an index of systolic performance of RV function. It evaluates the degree of myocardial deformation compared with its original length \[L0\] (%).

    Time frame: T0 (Patient's enrollment time)

  8. RV systolic function: RV Global Longitudinal strain (GLS), %

    RV Global Longitudinal strain (GLS) is an index of systolic performance of RV function. It evaluates the degree of myocardial deformation compared with its original length \[L0\] (%).

    Time frame: T1 (40 minutes after the first intervention has started)

  9. RV systolic function: RV Global Longitudinal strain (GLS), %

    RV Global Longitudinal strain (GLS) is an index of systolic performance of RV function. It evaluates the degree of myocardial deformation compared with its original length \[L0\] (%).

    Time frame: T2 (40 minutes after the second intervention has started)

Secondary outcomes

  1. LV systolic function: Left Ventricle Ejection Fraction (LV EF), %

    Parameter of LV systolic function Normal value \> 50%

    Time frame: T0 (Patient's enrollment time)

  2. LV systolic function: Left Ventricle Ejection Fraction (LV EF), %

    Parameter of LV systolic function Normal value \> 50%

    Time frame: T1 (40 minutes after the first intervention has started)

  3. LV systolic function: Left Ventricle Ejection Fraction (LV EF), %

    Parameter of LV systolic function Normal value \> 50%

    Time frame: T2 (40 minutes after the second intervention has started)

  4. LV diastolic function parameter, i.e. LV average E/E' ratio

    Parameter able to assess LV diastolic function. E/E' ratio normal value \< 12.

    Time frame: T0 (Patient's enrollment time)

  5. LV diastolic function parameter, i.e. LV average E/E' ratio

    Parameter able to assess LV diastolic function. E/E' ratio normal value \< 12.

    Time frame: T1 (40 minutes after the first intervention has started)

  6. LV diastolic function parameter, i.e. LV average E/E' ratio

    Parameter able to assess LV diastolic function. E/E' ratio normal value \< 12.

    Time frame: T2 (40 minutes after the second intervention has started)

  7. Inferior vena cava respiratory variations

    Echocardiographic parameter able to assess fluid responsiveness. Normal value \>50%.

    Time frame: T0 (Patient's enrollment time)

  8. Inferior vena cava respiratory variations

    Echocardiographic parameter able to assess fluid responsiveness. Normal value \>50%.

    Time frame: T1 (40 minutes after the first intervention has started)

  9. Inferior vena cava respiratory variations

    Echocardiographic parameter able to assess fluid responsiveness. Normal value \>50%.

    Time frame: T2 (40 minutes after the second intervention has started)

  10. Physiological parameter: mean arterial pressure (MAP), mmHg

    Normal value \>65 mmHg

    Time frame: T0 (Patient's enrollment time)

  11. Physiological parameter: mean arterial pressure (MAP), mmHg

    Normal value \>65 mmHg

    Time frame: T1 (40 minutes after the first intervention has started)

  12. Physiological parameter: mean arterial pressure (MAP), mmHg

    Normal value \>65 mmHg

    Time frame: T2 (40 minutes after the second intervention has started)

  13. Physiological parameter: oxygen saturation (SpO2), %

    Normal value \> 90%

    Time frame: T0 (Patient's enrollment time)

  14. Physiological parameter: oxygen saturation (SpO2), %

    Normal value \> 90%

    Time frame: T1 (40 minutes after the first intervention has started)

  15. Physiological parameter: oxygen saturation (SpO2), %

    Normal value \> 90%

    Time frame: T2 (40 minutes after the second intervention has started)

07

Study locations

1 of 1 sites recruiting
  • Fondazione IRCCS Policlinico Agostino Gemelli Roma
    Roma, 00168, Italy
    • Tommaso Sanna · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05989139
Lead sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Responsible party
Sanna Tommaso (Professor, Fondazione Policlinico Universitario Agostino Gemelli IRCCS) — Principal investigator
First posted
Aug 14, 2023
Start date
Jan 1, 2024
Primary completion
Jan 1, 2027 (estimated)
Completion
Apr 1, 2027 (estimated)
Last update
Aug 15, 2025

Study contacts

Tommaso Sanna
Contact
Tommaso.sanna@policlinicogemelli.it
00390630154187

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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