Predictive Value of Vasodilator Challenge for Right Heart Failure After LVAD Implantation (PREVV-RHF-LVAD)

San Camillo Hospital, Rome

Status: Enrolling

Conditions: Right Heart Failure

Treatments: Drug: Pulmonary Vasodilators

Study type: Observational

Funder types: Other

Identifiers

NCT05836233

1235/CE Lazio 1

Details and patient eligibility

About

Prospective evaluation of the predictive value for post-LVAD right ventricular failure (RHF) of pulmonary vasodilator challenge, in addition to current laboratory, echocardiographic and haemodynamic parameters.

LVAD candidates satisfying the inclusion criteria will undergo vasodilator challenge with sodium nitroprusside (NTP) infusion following the study protocol.

Thereafter, we will evaluate all data in order to determine which variables significantly correlate with RHF onset after LVAD implantation.

Full description

Inclusion criteria

• Age over 18 years old.
• Diagnosis of advanced heart failure with an indication for LVAD implantation.
• Mean Arterial Pressure (MAP) > 60 mmHg; Mean Pulmonary Arterial Pressure (mPAP) > 20 mmHg; Pulmonary Artery Wedge Pressure >15 mmHg.
• Vasodilator Challenge performed through NTP infusion.

Exclusion criteria

• State of pregnancy.
• Inability to perform vasodilator challenge
• Need for extracorporeal membrane oxygenator or short-term right ventricular assist devices.
• Planned right ventricular assist device implantation in the peri-procedural setting.

Right heart catheterization (RHC) RHC will be performed under optimal medical therapy within 90 days before LVAD implantation.

Vasodilator challenge will be performed through intravenous nitroprusside administration and titration (by 5 minutes intervals) until symptoms (flushing or hypotension) onset or systolic systemic pressure drops below 85 mmHg.

Dobutamine or phosphodiesterase inhibitors infusion could be performed at clinician's discretion.

All haemodynamic measurements will be repeated after nitroprusside infusion and titration.

Right heart failure (RHF) Post-operative RHF will be evaluated according to the definition proposed by the 2020 consensus statement of the mechanical circulatory support academic research consortium (1).

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• Age over 18 years old.
• Diagnosis of advanced heart failure with an indication for LVAD implantation.
• Mean Arterial Pressure (MAP) > 60 mmHg; Mean Pulmonary Arterial Pressure (mPAP) > 20 mmHg; Pulmonary Artery Wedge Pressure >15 mmHg.
• Vasodilator Challenge performed through NTP infusion.

Exclusion criteria

• State of pregnancy.
• Inability to perform vasodilator challenge
• Need for extracorporeal membrane oxygenator or short-term right ventricular assist devices.
• Planned right ventricular assist device implantation in the peri-procedural setting.

Trial design

150 participants in 1 patient group

Enrolled patients - LVAD candidates

Description:

Inclusion criteria * Age over 18 years old. * Diagnosis of advanced heart failure with an indication for LVAD implantation. * Mean Arterial Pressure (MAP) \> 60 mmHg; Mean Pulmonary Arterial Pressure (mPAP) \> 20 mmHg; Pulmonary Artery Wedge Pressure \>15 mmHg. * Vasodilator Challenge performed through NTP infusion. Exclusion criteria * State of pregnancy. * Inability to perform vasodilator challenge * Need for extracorporeal membrane oxygenator or short-term right ventricular assist devices. * Planned right ventricular assist device implantation in the peri-procedural setting.

Treatment:

Drug: Pulmonary Vasodilators