Mitigating Post-Op RV Dysfunction After LVAD Implantation

Sponsor

University of Chicago (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05758194

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Heart Failure Right Ventricular Dysfunction Right Ventricular Failure	Other: Standardized RV Management Other: Usual Care RV Management	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

Apr 1, 2024

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

RV failure defined by the 2014 Interagency Registry for Mechanical Circulatory Support (INTERMACS) [Through duration of hospitalization, up to 30 days following LVAD implantation]
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
RV failure defined by the 2020 Academic Research Consortium (ARC) [Through duration of hospitalization, up to 30 days following LVAD implantation]
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
Inotropic therapy [Through duration of hospitalization, up to 30 days following LVAD implantation]
Total number of inotropes used
Vasopressor therapy [Through duration of hospitalization, up to 30 days following LVAD implantation]
Total number of vasopressors used
Total time on inhaled nitric oxide [Through duration of hospitalization, up to 30 days following LVAD implantation]
Measured in days
Number of individuals who experience all-cause mortality [Through duration of hospitalization, up to 30 days following LVAD implantation]
All-cause mortality
ICU length of stay [Through duration of hospitalization, up to 30 days following LVAD implantation]
Measured in days
Hospital length of stay [Through duration of hospitalization, up to 30 days following LVAD implantation]
Measured in days
Number of individuals with acute kidney injuries requiring renal replacement therapy [Through duration of hospitalization, up to 30 days following LVAD implantation]
Acute kidney injury requiring renal replacement therapy (intermittent hemodialysis or continuous renal replacement therapy)
Number of individuals with transient ischemic attacks [TIA] or cerebrovascular accidents [CVA] [Through duration of hospitalization, up to 30 days following LVAD implantation]
Transient ischemic attack or cerebrovascular accident as diagnosed by a Neurologist either clinically and/or radiographically
Number of individuals with an arrhythmia requiring medical team intervention [Through duration of hospitalization, up to 30 days following LVAD implantation]
Arrhythmia requiring medical team intervention, either through electrical or chemical cardioversion or any intravenous anti-arrhythmia medication administration
Number of individuals who need tracheostomy [Through duration of hospitalization, up to 30 days following LVAD implantation]
Need for tracheostomy
Number of individuals needing percutaneous endoscopic gastrostomy tube [Through duration of hospitalization, up to 30 days following LVAD implantation]
Need for percutaneous endoscopic gastrostomy tube

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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