Clinical trial NCT05758194: Mitigating Post-Op RV Dysfunction After LVAD Implantation
Official title: Protective Strategies to Mitigate Post-Operative Right Ventricular (PV) Dysfunction After Centrifugal Flow Durable Left Ventricular Assist Device (LVAD) Implantation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Heart Failure
Right Ventricular Dysfunction
Right Ventricular Failure
Keywords: LVAD
LVAD-related complications
right ventricular dysfunction
hemocompatibility-related adverse events
hemodynamic-related events
post-operative right ventricular management
right ventricular failure
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2023-03-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in right atrial pressure (RAP) pre-LVAD implantation to post-operative day 3
timeFrame: Baseline, Day 3
measure: Change in right atrial pressure (RAP) pre-LVAD implantation to post-operative day 7
timeFrame: Baseline, Day 7
measure: Change in right atrial pressure (RAP) pre-LVAD implantation to end of hemodynamic monitoring post-LVAD implantation
timeFrame: Baseline, end of hemodynamic monitoring (about Day 10)
measure: Change in right atrial pressure/pulmonary capillary wedge pressure (RAP/PCWP) pre-LVAD implantation to post-operative day 3
timeFrame: Baseline, Day 3
measure: Change in right atrial pressure/pulmonary capillary wedge pressure (RAP/PCWP) pre-LVAD implantation to post-operative day 7
timeFrame: Baseline, Day 7
measure: Change in right atrial pressure/pulmonary capillary wedge pressure (RAP/PCWP) pre-LVAD implantation to end of hemodynamic monitoring post-LVAD implantation
timeFrame: Baseline, end of hemodynamic monitoring (about Day 10)
measure: Change in pulmonary artery pulsatility index (PAPI) pre-LVAD implantation to post-operative day 3
timeFrame: Baseline, Day 3
measure: Change in pulmonary artery pulsatility index (PAPI) pre-LVAD implantation to post-operative day 7
timeFrame: Baseline, Day 7
measure: Change in pulmonary artery pulsatility index (PAPI) pre-LVAD implantation to end of hemodynamic monitoring post-LVAD implantation
timeFrame: Baseline, end of hemodynamic monitoring (about Day 10)
measure: Change in right ventricle stroke work index (RVSWI) pre-LVAD implantation to post-operative day 3
timeFrame: Baseline, Day 3
measure: Change in right ventricle stroke work index (RVSWI) pre-LVAD implantation to post-operative day 7
timeFrame: Baseline, Day 7
measure: Change in right ventricle stroke work index (RVSWI) pre-LVAD implantation to end of hemodynamic monitoring post-LVAD implantation
timeFrame: Baseline, end of hemodynamic monitoring (about Day 10)
measure: Change in cardiac power output (CPO) pre-LVAD implantation to post-operative day 3
timeFrame: Baseline, Day 3
measure: Change in cardiac power output (CPO) pre-LVAD implantation to post-operative day 7
timeFrame: Baseline, Day 7
measure: Change in cardiac power output (CPO) pre-LVAD implantation to end of hemodynamic monitoring post-LVAD implantation
timeFrame: Baseline, end of hemodynamic monitoring (about Day 10)
Secondary outcomes:
measure: RV failure defined by the 2014 Interagency Registry for Mechanical Circulatory Support (INTERMACS)
timeFrame: Through duration of hospitalization, up to 30 days following LVAD implantation
measure: RV failure defined by the 2020 Academic Research Consortium (ARC)
timeFrame: Through duration of hospitalization, up to 30 days following LVAD implantation
measure: Inotropic therapy
timeFrame: Through duration of hospitalization, up to 30 days following LVAD implantation
measure: Vasopressor therapy
timeFrame: Through duration of hospitalization, up to 30 days following LVAD implantation
measure: Total time on inhaled nitric oxide
timeFrame: Through duration of hospitalization, up to 30 days following LVAD implantation
measure: Number of individuals who experience all-cause mortality
timeFrame: Through duration of hospitalization, up to 30 days following LVAD implantation
measure: ICU length of stay
timeFrame: Through duration of hospitalization, up to 30 days following LVAD implantation
measure: Hospital length of stay
timeFrame: Through duration of hospitalization, up to 30 days following LVAD implantation
measure: Number of individuals with acute kidney injuries requiring renal replacement therapy
timeFrame: Through duration of hospitalization, up to 30 days following LVAD implantation
measure: Number of individuals with transient ischemic attacks [TIA] or cerebrovascular accidents [CVA]
timeFrame: Through duration of hospitalization, up to 30 days following LVAD implantation
measure: Number of individuals with an arrhythmia requiring medical team intervention
timeFrame: Through duration of hospitalization, up to 30 days following LVAD implantation
measure: Number of individuals who need tracheostomy
timeFrame: Through duration of hospitalization, up to 30 days following LVAD implantation
measure: Number of individuals needing percutaneous endoscopic gastrostomy tube
timeFrame: Through duration of hospitalization, up to 30 days following LVAD implantation
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Jonathan Grinstein, MD
role: PRINCIPAL_INVESTIGATOR
References: