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

Recruiting

• Conditions: Right Heart Failure
• Interventions: Drug: Pulmonary Vasodilators

• Registration Number: NCT05836233
• Lead Sponsor: San Camillo Hospital, Rome

Brief Summary

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.

Detailed 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).

Study Timeline

• Study Start: 2023-02-15
• Status Verified: 2023-04
• Study First Submitted: 2023-04-18
• Study First Submitted QC: 2023-04-18
• Last Update Submitted: 2023-04-18
• Study First Posted: 2023-05-01
• Last Update Posted: 2023-05-01
• Primary Completion: 2025-01-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Enrolled patients - LVAD candidates	Pulmonary Vasodilators	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.

Primary Outcome Measures

Name	Time	Method
Primary Endpoint	18 months	Early right heart failure

Secondary Outcome Measures

Name	Time	Method
Secondary Endpoint	24 months	Late right heart failure

Trial Locations

Locations (1)

San Camillo Hospital; 🇮🇹 Roma, Italy