Pulmonary Edema Cardiac CauseHFvsNIVNCT05989139
HF vs NIV in Acute Cardiogenic Pulmonary Edema
A study testing NPPV/HFNC and HFNC/NPPV in people with Pulmonary Edema Cardiac Cause, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Edema Cardiac Cause
- What is being tested?
- NPPV/HFNC and HFNC/NPPV
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2024to 1 Apr 2027
- 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
- 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.
Who cannot join
- 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;
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione IRCCS Policlinico Agostino Gemelli Roma
Roma, 00168
Tommaso Sanna
About this study
Official title: Non-Invasive Ventilation And Right Ventricle Function In Cardiogenic Pulmonary Edema: An Echocardiographic Perspective To Select The Appropriate Ventilatory Support
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
- Being tested
- NPPV/HFNC, HFNC/NPPV
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NPPV/HFNCProcedure or surgery
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.
HFNC/NPPVProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| NPPV | Experimental | non-invasive positive-pressure ventilation arm Receives: Procedure: NPPV/HFNC |
| HFNC | Experimental | High-flow nasal cannulae arm Receives: Procedure: HFNC/NPPV |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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%.
Measured: 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%.
Measured: 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%.
Measured: 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] (%).
Measured: 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] (%).
Measured: 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] (%).
Measured: T2 (40 minutes after the second intervention has started)
Secondary outcomes (15)
LV systolic function: Left Ventricle Ejection Fraction (LV EF), %
Parameter of LV systolic function Normal value > 50%
Measured: T0 (Patient's enrollment time)
LV systolic function: Left Ventricle Ejection Fraction (LV EF), %
Parameter of LV systolic function Normal value > 50%
Measured: T1 (40 minutes after the first intervention has started)
LV systolic function: Left Ventricle Ejection Fraction (LV EF), %
Parameter of LV systolic function Normal value > 50%
Measured: T2 (40 minutes after the second intervention has started)
LV diastolic function parameter, i.e. LV average E/E' ratio
Parameter able to assess LV diastolic function. E/E' ratio normal value < 12.
Measured: T0 (Patient's enrollment time)
LV diastolic function parameter, i.e. LV average E/E' ratio
Parameter able to assess LV diastolic function. E/E' ratio normal value < 12.
Measured: T1 (40 minutes after the first intervention has started)
LV diastolic function parameter, i.e. LV average E/E' ratio
Parameter able to assess LV diastolic function. E/E' ratio normal value < 12.
Measured: T2 (40 minutes after the second intervention has started)
Inferior vena cava respiratory variations
Echocardiographic parameter able to assess fluid responsiveness. Normal value >50%.
Measured: T0 (Patient's enrollment time)
Inferior vena cava respiratory variations
Echocardiographic parameter able to assess fluid responsiveness. Normal value >50%.
Measured: T1 (40 minutes after the first intervention has started)
Inferior vena cava respiratory variations
Echocardiographic parameter able to assess fluid responsiveness. Normal value >50%.
Measured: T2 (40 minutes after the second intervention has started)
Physiological parameter: mean arterial pressure (MAP), mmHg
Normal value >65 mmHg
Measured: T0 (Patient's enrollment time)
Physiological parameter: mean arterial pressure (MAP), mmHg
Normal value >65 mmHg
Measured: T1 (40 minutes after the first intervention has started)
Physiological parameter: mean arterial pressure (MAP), mmHg
Normal value >65 mmHg
Measured: T2 (40 minutes after the second intervention has started)
Physiological parameter: oxygen saturation (SpO2), %
Normal value > 90%
Measured: T0 (Patient's enrollment time)
Physiological parameter: oxygen saturation (SpO2), %
Normal value > 90%
Measured: T1 (40 minutes after the first intervention has started)
Physiological parameter: oxygen saturation (SpO2), %
Normal value > 90%
Measured: T2 (40 minutes after the second intervention has started)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start1 Jan 2024
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Edema Cardiac CauseStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sanna Tommaso, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05989139
- Sponsor's protocol ID
- 5615
- Acronym
- HFvsNIV
- Status last verified
- Aug 2025
- First submitted
- 22 Jun 2023
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Ventilation And Right Ventricle Function In Cardiogenic Pulmonary Edema: An Echocardiographic Perspective To Select The Appropriate Ventilatory Support
- ClinicalTrials.gov ID
- NCT05989139
- Acronym / sponsor ID
- HFvsNIV / 5615
- Conditions
- Pulmonary Edema Cardiac Cause
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 14 Aug 2023 (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 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NPPV | Experimental | Procedure: NPPV/HFNCnon-invasive positive-pressure ventilation arm |
| HFNC | Experimental | Procedure: HFNC/NPPVHigh-flow nasal cannulae arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (16 listed)
- 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;
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 |
|---|---|---|
| NPPV/HFNCEnrolled 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. | Procedure or surgery | NPPV |
| HFNC/NPPVEnrolled 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. | Procedure or surgery | HFNC |
Primary outcome
RV systolic function: Tricuspid annular plane systolic excursion (TAPSE), mm
Time frame: T0 (Patient's enrollment time)
Tricuspid annular plane systolic excursion (TAPSE) is a parameter of global RV function which describes apex-to-base shortening. Normal value > 16 mm.
RV systolic function: Tricuspid annular plane systolic excursion (TAPSE), mm
Time frame: T1 (40 minutes after the first intervention has started)
Tricuspid annular plane systolic excursion (TAPSE) is a parameter of global RV function which describes apex-to-base shortening. Normal value > 16 mm.
RV systolic function: Tricuspid annular plane systolic excursion (TAPSE), mm
Time frame: T2 (40 minutes after the second intervention has started)
Tricuspid annular plane systolic excursion (TAPSE) is a parameter of global RV function which describes apex-to-base shortening. Normal value > 16 mm.
RV systolic function: RV fractional area change (RVFAC), %
Time frame: T0 (Patient's enrollment time)
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%.
RV systolic function: RV fractional area change (RVFAC), %
Time frame: T1 (40 minutes after the first intervention has started)
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%.
RV systolic function: RV fractional area change (RVFAC), %
Time frame: T2 (40 minutes after the second intervention has started)
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%.
RV systolic function: RV Global Longitudinal strain (GLS), %
Time frame: T0 (Patient's enrollment time)
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] (%).
RV systolic function: RV Global Longitudinal strain (GLS), %
Time frame: T1 (40 minutes after the first intervention has started)
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] (%).
RV systolic function: RV Global Longitudinal strain (GLS), %
Time frame: T2 (40 minutes after the second intervention has started)
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] (%).
15 secondary outcomes
LV systolic function: Left Ventricle Ejection Fraction (LV EF), %
Time frame: T0 (Patient's enrollment time)
LV systolic function: Left Ventricle Ejection Fraction (LV EF), %
Time frame: T1 (40 minutes after the first intervention has started)
LV systolic function: Left Ventricle Ejection Fraction (LV EF), %
Time frame: T2 (40 minutes after the second intervention has started)
LV diastolic function parameter, i.e. LV average E/E' ratio
Time frame: T0 (Patient's enrollment time)
LV diastolic function parameter, i.e. LV average E/E' ratio
Time frame: T1 (40 minutes after the first intervention has started)
LV diastolic function parameter, i.e. LV average E/E' ratio
Time frame: T2 (40 minutes after the second intervention has started)
Inferior vena cava respiratory variations
Time frame: T0 (Patient's enrollment time)
Inferior vena cava respiratory variations
Time frame: T1 (40 minutes after the first intervention has started)
Inferior vena cava respiratory variations
Time frame: T2 (40 minutes after the second intervention has started)
Physiological parameter: mean arterial pressure (MAP), mmHg
Time frame: T0 (Patient's enrollment time)
Physiological parameter: mean arterial pressure (MAP), mmHg
Time frame: T1 (40 minutes after the first intervention has started)
Physiological parameter: mean arterial pressure (MAP), mmHg
Time frame: T2 (40 minutes after the second intervention has started)
Physiological parameter: oxygen saturation (SpO2), %
Time frame: T0 (Patient's enrollment time)
Physiological parameter: oxygen saturation (SpO2), %
Time frame: T1 (40 minutes after the first intervention has started)
Physiological parameter: oxygen saturation (SpO2), %
Time frame: T2 (40 minutes after the second intervention has started)
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 15 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Pulmonary Edema Cardiac Cause
Not yet recruitingObservational study
Hemodynamic Evaluation of Left Atrial Pressure in Relationship to Pulmonary Capillary Wedge Pressure in Cardio Thoracic Patients
Cardiogenic Shock, Pulmonary Edema Cardiac Cause
Recruiting
A Randomized Placebo-procedure Controlled Trial of the Enhancor System (PULmonary Artery Denervation) to Evaluate Safety and Efficacy in Patients With Combined Pre- and Post-capillary Pulmonary Hypertension Associated With Left Heart Disease
Pulmonary Hypertension, Heart Failure With Reduced Ejection Fraction
Active, not recruitingPhase 3
A Trial to Evaluate the Safety and Efficacy of Pulmonary Artery Denervation for the Treatment of Pulmonary Hypertension Associated With Left Heart Failure
Pulmonary Hypertension, Heart Failure With Reduced Ejection Fraction
RecruitingObservational study
AI-Enabled Direct-from-ECG Ejection Fraction (EF) Severity Assessment Using COR ECG Wearable Monitor
Ventricular Ejection Fraction, LVF
Active, not recruitingPhase 1/2
IC14 for Treatment of Acute Decompensated Heart Failure
Acute Decompensated Heart Failure
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 NPPV/HFNC and HFNC/NPPV in people with Pulmonary Edema Cardiac Cause, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 5 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 15 Aug 2025. 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 Italy. 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 Tommaso Sanna (00390630154187, Tommaso.sanna@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RV systolic function: Tricuspid annular plane systolic excursion (TAPSE), mm (time frame: T0 (Patient's enrollment time)). The study lists 9 primary outcomes in all. 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 15 Aug 2025.