Heart FailureNCT05758194
Mitigating Post-Op RV Dysfunction After LVAD Implantation
A study testing Standardized RV Management in people with Heart Failure and Right Ventricular Dysfunction, run by University of Chicago at 1 site in United States.
Trial summary
This project evaluates right ventricle (RV) protective strategies after left ventricular assist device (LVAD) implantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Right Ventricular Dysfunction, Right Ventricular Failure
- What is being tested?
- Standardized RV Management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2023to 28 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Undergoing durable LVAD implantation without plan for perioperative right ventricular mechanical circulatory support
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Being tested
- Standardized RV Management, Usual Care RV Management
- Keywords
- LVAD, LVAD-related complications, right ventricular dysfunction, hemocompatibility-related adverse events, hemodynamic-related events, post-operative right ventricular management, right ventricular failure
- Medical subject headings
- Heart Failure, Ventricular Dysfunction, Right
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized RV ManagementOther
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 ManagementOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Standardized RV Management | Active comparator | Physicians will follow prespecified parameters for RV management (consistent with SOC) Receives: Other: Standardized RV Management |
| Usual Care RV Management | Active comparator | Physicians will use their own clinical judgement with no prespecified goals for RV management parameters (consistent with SOC) Receives: Other: Usual Care RV Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in right atrial pressure (RAP) pre-LVAD implantation to post-operative day 3
RAP measured by pulmonary artery catheter
Measured: Baseline, Day 3
Change in right atrial pressure (RAP) pre-LVAD implantation to post-operative day 7
RAP measured by pulmonary artery catheter
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline, Day 3
Change in pulmonary artery pulsatility index (PAPI) pre-LVAD implantation to post-operative day 7
PAPI measured by pulmonary artery catheter
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline, Day 3
Change in cardiac power output (CPO) pre-LVAD implantation to post-operative day 7
CPO measured by pulmonary artery catheter
Measured: 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
Measured: Baseline, end of hemodynamic monitoring (about Day 10)
Secondary outcomes (13)
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
Measured: 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
Measured: Through duration of hospitalization, up to 30 days following LVAD implantation
Inotropic therapy
Total number of inotropes used
Measured: Through duration of hospitalization, up to 30 days following LVAD implantation
Vasopressor therapy
Total number of vasopressors used
Measured: Through duration of hospitalization, up to 30 days following LVAD implantation
Total time on inhaled nitric oxide
Measured in days
Measured: Through duration of hospitalization, up to 30 days following LVAD implantation
Number of individuals who experience all-cause mortality
All-cause mortality
Measured: Through duration of hospitalization, up to 30 days following LVAD implantation
ICU length of stay
Measured in days
Measured: Through duration of hospitalization, up to 30 days following LVAD implantation
Hospital length of stay
Measured in days
Measured: 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)
Measured: 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
Measured: 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
Measured: Through duration of hospitalization, up to 30 days following LVAD implantation
Number of individuals who need tracheostomy
Need for tracheostomy
Measured: 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
Measured: Through duration of hospitalization, up to 30 days following LVAD implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2023
- Study start22 Mar 2023
- Primary completion31 Dec 2024
- Study completion28 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan Grinstein, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05758194
- Sponsor's protocol ID
- IRB22-0972
- Status last verified
- Oct 2025
- First submitted
- 24 Feb 2023
- Last updated
- 16 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protective Strategies to Mitigate Post-Operative Right Ventricular (PV) Dysfunction After Centrifugal Flow Durable Left Ventricular Assist Device (LVAD) Implantation
- ClinicalTrials.gov ID
- NCT05758194
- Acronym / sponsor ID
- IRB22-0972
- Keywords
- LVAD, LVAD-related complications, right ventricular dysfunction, hemocompatibility-related adverse events, hemodynamic-related events, post-operative right ventricular management, right ventricular failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 22 Mar 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 28 Mar 2025 (actual)
- First posted
- 7 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standardized RV Management | Active comparator | Other: Standardized RV ManagementPhysicians will follow prespecified parameters for RV management (consistent with SOC) |
| Usual Care RV Management | Active comparator | Other: Usual Care RV ManagementPhysicians will use their own clinical judgement with no prespecified goals for RV management parameters (consistent with SOC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Undergoing durable LVAD implantation without plan for perioperative right ventricular mechanical circulatory support
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized RV ManagementStandardized parameters for post-operative management (i.e., Rhythm Management, Ventilation Management, RV Ischemia Management, RV Preload, RV Afterload, RV Contractility, and RV Geometry) | Other | Standardized RV Management |
| Usual Care RV ManagementNo standardized parameters for post-operative management (i.e., Rhythm Management, Ventilation Management, RV Ischemia Management, RV Preload, RV Afterload, RV Contractility, and RV Geometry) | Other | Usual Care RV Management |
Primary outcome
Change in right atrial pressure (RAP) pre-LVAD implantation to post-operative day 3
Time frame: Baseline, Day 3
RAP measured by pulmonary artery catheter
Change in right atrial pressure (RAP) pre-LVAD implantation to post-operative day 7
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline, Day 3
PAPI measured by pulmonary artery catheter
Change in pulmonary artery pulsatility index (PAPI) pre-LVAD implantation to post-operative day 7
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline, Day 3
CPO measured by pulmonary artery catheter
Change in cardiac power output (CPO) pre-LVAD implantation to post-operative day 7
Time frame: 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
Time frame: Baseline, end of hemodynamic monitoring (about Day 10)
CPO measured by pulmonary artery catheter
13 secondary outcomes
RV failure defined by the 2014 Interagency Registry for Mechanical Circulatory Support (INTERMACS)
Time frame: Through duration of hospitalization, up to 30 days following LVAD implantation
RV failure defined by the 2020 Academic Research Consortium (ARC)
Time frame: Through duration of hospitalization, up to 30 days following LVAD implantation
Inotropic therapy
Time frame: Through duration of hospitalization, up to 30 days following LVAD implantation
Vasopressor therapy
Time frame: Through duration of hospitalization, up to 30 days following LVAD implantation
Total time on inhaled nitric oxide
Time frame: Through duration of hospitalization, up to 30 days following LVAD implantation
Number of individuals who experience all-cause mortality
Time frame: Through duration of hospitalization, up to 30 days following LVAD implantation
ICU length of stay
Time frame: Through duration of hospitalization, up to 30 days following LVAD implantation
Hospital length of stay
Time frame: Through duration of hospitalization, up to 30 days following LVAD implantation
Number of individuals with acute kidney injuries requiring renal replacement therapy
Time frame: Through duration of hospitalization, up to 30 days following LVAD implantation
Number of individuals with transient ischemic attacks [TIA] or cerebrovascular accidents [CVA]
Time frame: Through duration of hospitalization, up to 30 days following LVAD implantation
Number of individuals with an arrhythmia requiring medical team intervention
Time frame: Through duration of hospitalization, up to 30 days following LVAD implantation
Number of individuals who need tracheostomy
Time frame: Through duration of hospitalization, up to 30 days following LVAD implantation
Number of individuals needing percutaneous endoscopic gastrostomy tube
Time frame: Through duration of hospitalization, up to 30 days following LVAD implantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Grinstein, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized RV Management in people with Heart Failure and Right Ventricular Dysfunction, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in right atrial pressure (RAP) pre-LVAD implantation to post-operative day 3 (time frame: Baseline, Day 3). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2025.