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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05758194
Other study ID # IRB22-0972
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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