HF vs NIV in Acute Cardiogenic Pulmonary Edema

NCT05989139 | Recruiting

• 1 other identifier: 5615
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Pulmonary Edema Cardiac Cause

Outcome Measures

Primary Outcomes (9)

• 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.

  T0 (Patient's enrollment time)

• 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.

  T1 (40 minutes after the first intervention has started)

• 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.

  T2 (40 minutes after the second intervention has started)

• 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%.

  T0 (Patient's enrollment time)

• 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%.

  T1 (40 minutes after the first intervention has started)

• 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%.

  T2 (40 minutes after the second intervention has started)

• 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 \[L0\] (%).

  T0 (Patient's enrollment time)

• 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 \[L0\] (%).

  T1 (40 minutes after the first intervention has started)

• 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 \[L0\] (%).

  T2 (40 minutes after the second intervention has started)

Secondary Outcomes (15)

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

  T0 (Patient's enrollment time)

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

  T1 (40 minutes after the first intervention has started)

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

  T2 (40 minutes after the second intervention has started)

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

  T0 (Patient's enrollment time)

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

  T1 (40 minutes after the first intervention has started)

Study Arms (2)

NPPV

EXPERIMENTAL

non-invasive positive-pressure ventilation arm

Procedure: NPPV/HFNC

HFNC

EXPERIMENTAL

High-flow nasal cannulae arm

Procedure: HFNC/NPPV

Interventions

NPPV/HFNC PROCEDURE

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.

NPPV

HFNC/NPPV PROCEDURE

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.

HFNC

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione IRCCS Policlinico Agostino Gemelli Roma

Roma, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Tommaso Sanna

CONTACT

00390630154187; Tommaso.sanna@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: August 14, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)