Predictive Value of Vasodilator Challenge for Right Heart Failure After LVAD Implantation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-15

Study Completion Date

2025-08-01

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Right Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Enrolled patients - LVAD candidates

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.

Pulmonary Vasodilators

Intervention Type DRUG

Right heart catheterization via Swan Ganz catether will be performed under optimal medical therapy within 90 days before LVAD implantation. We will record the timing between RHC and 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 drop below 85 mmHg (target dose).

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

All haemodynamic measurements will be repeated after nitroprusside infusion and titration until the target dose.

Interventions

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Pulmonary Vasodilators

Right heart catheterization via Swan Ganz catether will be performed under optimal medical therapy within 90 days before LVAD implantation. We will record the timing between RHC and 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 drop below 85 mmHg (target dose).

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

All haemodynamic measurements will be repeated after nitroprusside infusion and titration until the target dose.

Intervention Type DRUG

Other Intervention Names

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Vasodilator Challenge

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No