Mitigating Post-Op RV Dysfunction After LVAD Implantation

Protective Strategies to Mitigate Post-Operative Right Ventricular (PV) Dysfunction After Centrifugal Flow Durable Left Ventricular Assist Device (LVAD) Implantation

This project evaluates right ventricle (RV) protective strategies after left ventricular assist device (LVAD) implantation.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Right Ventricular Dysfunction; Right Ventricular Failure
• Intervention / Treatment: Other: Standardized RV Management; Other: Usual Care RV Management

Detailed Description

The main purpose of this study is to learn more about protecting against RV dysfunction and RV failure (RVF) in patients receiving LVAD implantations.

This is a prospective, randomized controlled study that will include 20 patients with heart failure undergoing LVAD implantation. Patients will receive their LVAD implantation as part of routine care. Patients will be randomized 1:1 to one of two arms, 1) standardized RV management arm, and 2) usual care RV management arm, which are both consistent with standard of care (SOC).

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anthony J Kanelidis, MD; Phone Number: (773) 702-9396; Email: Anthony.Kanelidis@uchicagomedicine.org

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Recruiting
      • University of Chicago
      • Contact: Anthony J Kanelidis, MD; Phone Number: 773-702-9396; Email: Anthony.Kanelidis@uchicagomedicine.org
      • Principal Investigator: Jonathan Grinstein, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 18 years
• Undergoing durable LVAD implantation without plan for perioperative right ventricular mechanical circulatory support

Exclusion Criteria:

• Patients with pre-operative right ventricular mechanical circulatory support or having high likelihood of requiring right ventricular mechanical circulatory support.
• Patients with RV implantable cardiac device (ICD)/pacemaker lead who are pacemaker-dependent
• Pregnant patients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standardized RV Management; Physicians will follow prespecified parameters for RV management (consistent with SOC)	Other: Standardized RV Management; Standardized parameters for post-operative management (i.e., Rhythm Management, Ventilation Management, RV Ischemia Management, RV Preload, RV Afterload, RV Contractility, and RV Geometry)
Active Comparator: Usual Care RV Management; Physicians will use their own clinical judgement with no prespecified goals for RV management parameters (consistent with SOC)	Other: Usual Care RV Management; No standardized parameters for post-operative management (i.e., Rhythm Management, Ventilation Management, RV Ischemia Management, RV Preload, RV Afterload, RV Contractility, and RV Geometry)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in right atrial pressure (RAP) pre-LVAD implantation to post-operative day 3	RAP measured by pulmonary artery catheter	Baseline, Day 3
Change in right atrial pressure (RAP) pre-LVAD implantation to post-operative day 7	RAP measured by pulmonary artery catheter	Baseline, Day 7
Change in right atrial pressure (RAP) pre-LVAD implantation to end of hemodynamic monitoring post-LVAD implantation	RAP measured by pulmonary artery catheter	Baseline, end of hemodynamic monitoring (about Day 10)
Change in right atrial pressure/pulmonary capillary wedge pressure (RAP/PCWP) pre-LVAD implantation to post-operative day 3	RAP/PCWP measured by pulmonary artery catheter	Baseline, Day 3
Change in right atrial pressure/pulmonary capillary wedge pressure (RAP/PCWP) pre-LVAD implantation to post-operative day 7	RAP/PCWP measured by pulmonary artery catheter	Baseline, Day 7
Change in right atrial pressure/pulmonary capillary wedge pressure (RAP/PCWP) pre-LVAD implantation to end of hemodynamic monitoring post-LVAD implantation	RAP/PCWP measured by pulmonary artery catheter	Baseline, end of hemodynamic monitoring (about Day 10)
Change in pulmonary artery pulsatility index (PAPI) pre-LVAD implantation to post-operative day 3	PAPI measured by pulmonary artery catheter	Baseline, Day 3
Change in pulmonary artery pulsatility index (PAPI) pre-LVAD implantation to post-operative day 7	PAPI measured by pulmonary artery catheter	Baseline, Day 7
Change in pulmonary artery pulsatility index (PAPI) pre-LVAD implantation to end of hemodynamic monitoring post-LVAD implantation	PAPI measured by pulmonary artery catheter	Baseline, end of hemodynamic monitoring (about Day 10)
Change in right ventricle stroke work index (RVSWI) pre-LVAD implantation to post-operative day 3	RVSWI measured by pulmonary artery catheter	Baseline, Day 3
Change in right ventricle stroke work index (RVSWI) pre-LVAD implantation to post-operative day 7	RVSWI measured by pulmonary artery catheter	Baseline, Day 7
Change in right ventricle stroke work index (RVSWI) pre-LVAD implantation to end of hemodynamic monitoring post-LVAD implantation	RVSWI measured by pulmonary artery catheter	Baseline, end of hemodynamic monitoring (about Day 10)
Change in cardiac power output (CPO) pre-LVAD implantation to post-operative day 3	CPO measured by pulmonary artery catheter	Baseline, Day 3
Change in cardiac power output (CPO) pre-LVAD implantation to post-operative day 7	CPO measured by pulmonary artery catheter	Baseline, Day 7
Change in cardiac power output (CPO) pre-LVAD implantation to end of hemodynamic monitoring post-LVAD implantation	CPO measured by pulmonary artery catheter	Baseline, end of hemodynamic monitoring (about Day 10)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RV failure defined by the 2014 Interagency Registry for Mechanical Circulatory Support (INTERMACS)	The INTERMACS definition of RVF stratifies patients based on duration of inotropic therapy, inhaled nitric oxide therapy, vasodilator therapy or RVAD implantation. RVF is described as mild, moderate, severe, or severe acute based on ≤7, 8-14, >14 days of the above therapies or RVAD implantation, respectively	Through duration of hospitalization, up to 30 days following LVAD implantation
RV failure defined by the 2020 Academic Research Consortium (ARC)	The ARC definition of RVF stratifies patients based on the onset of RVF (e.g. early acute right heart failure, early post-implant right heart failure, or late right heart failure) requiring inotropic therapy or RVAD implantation during LVAD implantation, <30 days post-operatively, or >30 days post-operatively, respectively	Through duration of hospitalization, up to 30 days following LVAD implantation
Inotropic therapy	Total number of inotropes used	Through duration of hospitalization, up to 30 days following LVAD implantation
Vasopressor therapy	Total number of vasopressors used	Through duration of hospitalization, up to 30 days following LVAD implantation
Total time on inhaled nitric oxide	Measured in days	Through duration of hospitalization, up to 30 days following LVAD implantation
Number of individuals who experience all-cause mortality	All-cause mortality	Through duration of hospitalization, up to 30 days following LVAD implantation
ICU length of stay	Measured in days	Through duration of hospitalization, up to 30 days following LVAD implantation
Hospital length of stay	Measured in days	Through duration of hospitalization, up to 30 days following LVAD implantation
Number of individuals with acute kidney injuries requiring renal replacement therapy	Acute kidney injury requiring renal replacement therapy (intermittent hemodialysis or continuous renal replacement therapy)	Through duration of hospitalization, up to 30 days following LVAD implantation
Number of individuals with transient ischemic attacks [TIA] or cerebrovascular accidents [CVA]	Transient ischemic attack or cerebrovascular accident as diagnosed by a Neurologist either clinically and/or radiographically	Through duration of hospitalization, up to 30 days following LVAD implantation
Number of individuals with an arrhythmia requiring medical team intervention	Arrhythmia requiring medical team intervention, either through electrical or chemical cardioversion or any intravenous anti-arrhythmia medication administration	Through duration of hospitalization, up to 30 days following LVAD implantation
Number of individuals who need tracheostomy	Need for tracheostomy	Through duration of hospitalization, up to 30 days following LVAD implantation
Number of individuals needing percutaneous endoscopic gastrostomy tube	Need for percutaneous endoscopic gastrostomy tube	Through duration of hospitalization, up to 30 days following LVAD implantation

Collaborators and Investigators

• Sponsor: University of Chicago
• Investigators: Principal Investigator: Jonathan Grinstein, MD, University of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2023
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: February 24, 2023
• First Submitted That Met QC Criteria: February 24, 2023
• First Posted (Actual): March 7, 2023

Study Record Updates

• Last Update Posted (Estimated): December 19, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: LVAD; right ventricular dysfunction; right ventricular failure; LVAD-related complications; hemocompatibility-related adverse events; hemodynamic-related events; post-operative right ventricular management
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Ventricular Dysfunction; Ventricular Dysfunction, Right
• Other Study ID Numbers: IRB22-0972

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