Mitigating Post-Op RV Dysfunction After LVAD Implantation

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05758194
• Other study ID #: IRB22-0972
• Status: Recruiting
• Phase: N/A
• Start date: March 22, 2023
• Est. completion date: April 2024

Study information

• Verified date: December 2023
• Source: University of Chicago
• Contact: Anthony J Kanelidis, MD
• Phone: (773) 702-9396
• Email: Anthony.Kanelidis[@]uchicagomedicine.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Right Ventricular Dysfunction
• Right Ventricular Failure
• Ventricular Dysfunction
• Ventricular Dysfunction, Right

Intervention

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)
• 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)

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in right atrial pressure (RAP) pre-LVAD implantation to post-operative day 3	RAP measured by pulmonary artery catheter	Baseline, Day 3
Primary	Change in right atrial pressure (RAP) pre-LVAD implantation to post-operative day 7	RAP measured by pulmonary artery catheter	Baseline, Day 7
Primary	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)
Primary	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
Primary	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
Primary	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)
Primary	Change in pulmonary artery pulsatility index (PAPI) pre-LVAD implantation to post-operative day 3	PAPI measured by pulmonary artery catheter	Baseline, Day 3
Primary	Change in pulmonary artery pulsatility index (PAPI) pre-LVAD implantation to post-operative day 7	PAPI measured by pulmonary artery catheter	Baseline, Day 7
Primary	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)
Primary	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
Primary	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
Primary	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)
Primary	Change in cardiac power output (CPO) pre-LVAD implantation to post-operative day 3	CPO measured by pulmonary artery catheter	Baseline, Day 3
Primary	Change in cardiac power output (CPO) pre-LVAD implantation to post-operative day 7	CPO measured by pulmonary artery catheter	Baseline, Day 7
Primary	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	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
Secondary	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
Secondary	Inotropic therapy	Total number of inotropes used	Through duration of hospitalization, up to 30 days following LVAD implantation
Secondary	Vasopressor therapy	Total number of vasopressors used	Through duration of hospitalization, up to 30 days following LVAD implantation
Secondary	Total time on inhaled nitric oxide	Measured in days	Through duration of hospitalization, up to 30 days following LVAD implantation
Secondary	Number of individuals who experience all-cause mortality	All-cause mortality	Through duration of hospitalization, up to 30 days following LVAD implantation
Secondary	ICU length of stay	Measured in days	Through duration of hospitalization, up to 30 days following LVAD implantation
Secondary	Hospital length of stay	Measured in days	Through duration of hospitalization, up to 30 days following LVAD implantation
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of individuals who need tracheostomy	Need for tracheostomy	Through duration of hospitalization, up to 30 days following LVAD implantation
Secondary	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