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

Predictive Value of Vasodilator Challenge for Right Heart Failure (RHF) After Left Ventricular Assist Device (LVAD) Implantation

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.

Study Overview

• Status: Recruiting
• Conditions: Right Heart Failure
• Intervention / Treatment: Drug: Pulmonary Vasodilators

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 Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Giulio Cacioli, MD; Phone Number: +3906 58704604; Email: giulio.cacioli@gmail.com
• Study Contact Backup: Name: Fabio Sbaraglia, MD; Phone Number: +3906 58704604; Email: fsbaraglia@gmail.com

Study Locations

• Italy
  • Roma, Italy, 00152
    • Recruiting
    • San Camillo Hospital
    • Contact: Giulio Cacioli, MD; Phone Number: +390658704604; Email: giulio.cacioli@gmail.com
    • Contact: Fabio Sbaraglia, MD; Phone Number: +390658704604; Email: fsbaraglia@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Advanced heart failure patients undergoing left ventricular assist device implantation in our centers satisfying the inclusion criteria.

All patients presenting one or more of the exclusion criteria will not be included in the study.

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Drug: 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.; Other Names: Vasodilator Challenge

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Endpoint	Early right heart failure	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Endpoint	In-hospital all-cause mortality	24 months
Secondary Endpoint	1-year all-cause mortality;	24 months
Secondary Endpoint	Late right heart failure	24 months

Collaborators and Investigators

• Sponsor: San Camillo Hospital, Rome
• Collaborators: Azienda Ospedaliero Universitaria, Santa Maria della Misericordia di Udine, Italy
• Investigators: Principal Investigator: Francesco Musumeci, MD, San Camillo Hospital

Publications and helpful links

General Publications

• Kormos RL, Antonides CFJ, Goldstein DJ, Cowger JA, Starling RC, Kirklin JK, Rame JE, Rosenthal D, Mooney ML, Caliskan K, Messe SR, Teuteberg JJ, Mohacsi P, Slaughter MS, Potapov EV, Rao V, Schima H, Stehlik J, Joseph S, Koenig SC, Pagani FD. Updated definitions of adverse events for trials and registries of mechanical circulatory support: A consensus statement of the mechanical circulatory support academic research consortium. J Heart Lung Transplant. 2020 Aug;39(8):735-750. doi: 10.1016/j.healun.2020.03.010. Epub 2020 Apr 18. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2023
• Primary Completion (Anticipated): January 1, 2025
• Study Completion (Anticipated): August 1, 2025

Study Registration Dates

• First Submitted: April 18, 2023
• First Submitted That Met QC Criteria: April 18, 2023
• First Posted (Actual): May 1, 2023

Study Record Updates

• Last Update Posted (Actual): May 1, 2023
• Last Update Submitted That Met QC Criteria: April 18, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Right Heart Failure; LVAD; Advanced Heart Failure; Right Heart Catheterization; Nitroprusside
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Vasodilator Agents
• Other Study ID Numbers: 1235/CE Lazio 1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No