Cardiogenic ShockNCT04478188
Pressure Volume Loop
An observational study of Cardiogenic Shock and Decompensated Heart Failure, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
The investigators are doing this study and medical record review to measure simultaneous pressure and volume of the heart called pressure volumes loops before and after ventricular assist device placement for cardiogenic shock ( a severe form of heart failure). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiogenic Shock, Decompensated Heart Failure
- What is being tested?
- Measuring Pressure Volume Loop Pre and Post Device Placement
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2020to Jul 2023
- Phase
- Observational
- 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
- Adult, Older adult
Study population: All cardiogenic shock patients requiring mechanical circulatory support devices can be enrolled in the study. The patients chart will be examined for possible exclusion by the PI or implanting surgeon who is also a co-investigator.
Who may be able to join
- All cardiogenic shock patients requiring temporary mechanical circulatory support (TMCS) (Impella, Tandem heart and ECMO). Age >=18
- -
Who cannot join
- Age <18, All patients requiring ECRP
- Patients with a Mechanical Aortic Valve
- Patients with Left Ventricular Thrombus
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Danny Ramzy, MD, 310-423-1877, Danny.Ramzy@cshs.org
Soheila Abbassi, MBA, 310-423-5086, soheila.abbassi@cshs.org
About this study
Official title: The Use of PV Loop Analysis to Optimize Cardiogenic Shock and Device Management
The investigators are doing this study and medical record review to measure simultaneous pressure and volume of the heart called pressure volumes loops before and after ventricular assist device placement for cardiogenic shock ( a severe form of heart failure). Standard of care measurements will be the sole measure of clinical determination. The investigators are measuring these PV loops to help determine which patients heart have recovered and can have the ventricular assist device removed. The investigators are also using the PV loop to indicate/correlate with certain outcomes to predict the need for LVAD patients to require additional support in the form of a right ventricular assist device. The medical record review will be performed pre-operatively, intra-operatively, and post-operatively until the day of discharge.
Read the detailed description
Cardiogenic shock (CS) represents a high risk population that is at risk for both in-hospital mortality and readmission following discharge. CS can be either left ventricular (LV) or right ventricular (RV) or of biventricular (BiV) origin. Even in patients with CS treated with an invasive approach (cardiac catheterization, angioplasty, and coronary bypass surgery), in-hospital mortality approaches 50%. Other causes of CS mainly include severe decline in underlying systolic function (from non-ischemic causes such as sepsis, stress, and progression of systolic left ventricular dysfunction among others), arrhythmias, and mechanical cardiac complications. Cardiogenic shock in the absence of acute myocardial infarction (AMI) (non-AMI CS) is excluded from most studies including randomized trials and remains largely understudied. For many years, the intra-aortic balloon pump was thought to be helpful in improving outcomes in cardiogenic shock. However, the landmark randomized, controlled IABP-SHOCK II trial, published in 2012, and concluded that the use of intra-aortic balloon counter pulsation did not significantly reduce mortality in patients with cardiogenic shock complicating acute myocardial infarction. This led investigators to search for alternate temporary mechanical circulatory support systems that might prove effective in reducing mortality in cardiogenic shock. One such system is the Impella 5.0 and Impella RP devices. The Impella 5.0 pump in a temporary continuous flow pump approved for hemodynamic support for left ventricular shock CS patient and the Impella RP for right ventricular shock. The other system is the Tandem heart pump. The investigators utilize the Impella and the tandem pump for AMI CS and non-ischemic CS. The device is implanted for bridge to recovery, bridge to transplant and as a bridge to durable device. The investigators have discovered that recovery rates following AMI shock are significantly improved with the Impellaand tandem heart pumps however; identifying which patient recovers remains a mystery. Adequate parameters do not exist.
Patients who we are unable to recover are transitioned to a durable continuous flow left ventricular assist devices (CF-LVAD) which are an effective alternative to heart transplant, but are not risk-free: among the other effects, right ventricle (RV) hemodynamics are significantly altered by the LVAD implantation. In fact, RV failure occurs in 5% of patients with implanted CF-LVADs, and leads to a 6-fold increase in the risk of death. Moreover, RV failure is a major contributing factor in prolonged hospitalizations, and is associated with a higher risk of bleeding, renal failure, and hypotension. Currently, predictors of RV failure in patients undergoing LVAD implantation are based entirely on retrospective case series, often evaluating cohorts of patients with outdated classes of pulsatile-flow LVADs.Furthermore, right ventricular failure (RVF) still results as the major cause of morbidity and mortality after LVAD implantation. Despite overall improved outcomes and lower rates of RVF with the use of the newer, LVAD over pulsatile-flow devices, and development of clinical prediction scores to facilitate preoperative identification of patients at risk for RVF after implantation remains elusive. RVF occurs in 13% to 40% of continuous-flow device. The ability to predict the development of RV failure post LVAD implantation would significantly improve outcomes as these patients would either have planned RVAD implantation or receive a total artificial heart implantation.
- Conditions
- Cardiogenic Shock, Decompensated Heart Failure
- Being tested
- Measuring Pressure Volume Loop Pre and Post Device Placement
- Medical subject headings
- Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measuring Pressure Volume Loop Pre and Post Device PlacementOther
To measure simultaneous pressure and volume of the heart (pressure volumes loops) before and after ventricular assist device placement for cardiogenic shock (a severe form of heart failure) and before and after device removal.
| Study group | Role | What they receive |
|---|---|---|
| Cardiogenic Shock Patients Needing TMCS | Heart failure patients who undergo TMCS insertion for acute decompensated heart failure and cardiogenic shock. Receives: Other: Measuring Pressure Volume Loop Pre and Post Device Placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventricular Pressure Volume Loop Analysis
Three Load independent Parameters will be measured and analyzed at three different time points. Pre, post implant and at explant
Measured: Up to 90 days
Secondary outcomes (1)
Survival and device explant rate
Measurement of the proportion of patients that were able to be weaned off the device and percent survival
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study startAug 2020 (estimated)
- Primary completionJul 2021 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Danny Ramzy, Cedars-Sinai Medical Center
- Investigators
- Danny Ramzy, MD, Principal investigator, Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04478188
- Sponsor's protocol ID
- 00000164
- Status last verified
- Jul 2020
- First submitted
- 13 Jul 2020
- Last updated
- 20 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: At this time there are no plans to share individual participant data with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of PV Loop Analysis to Optimize Cardiogenic Shock and Device Management
- ClinicalTrials.gov ID
- NCT04478188
- Acronym / sponsor ID
- 00000164
- Conditions
- Cardiogenic Shock, Decompensated Heart Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- Aug 2020 (estimated)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 20 Jul 2020 (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.
The investigators are doing this study and medical record review to measure simultaneous pressure and volume of the heart called pressure volumes loops before and after ventricular assist device placement for cardiogenic shock ( a severe form of heart failure). Standard of care measurements will be the sole measure of clinical determination. The investigators are measuring these PV loops to help determine which patients heart have recovered and can have the ventricular assist device removed. The investigators are also using the PV loop to indicate/correlate with certain outcomes to predict the need for LVAD patients to require additional support in the form of a right ventricular assist device. The medical record review will be performed pre-operatively, intra-operatively, and post-operatively until the day of discharge.
Detailed description
Cardiogenic shock (CS) represents a high risk population that is at risk for both in-hospital mortality and readmission following discharge. CS can be either left ventricular (LV) or right ventricular (RV) or of biventricular (BiV) origin. Even in patients with CS treated with an invasive approach (cardiac catheterization, angioplasty, and coronary bypass surgery), in-hospital mortality approaches 50%. Other causes of CS mainly include severe decline in underlying systolic function (from non-ischemic causes such as sepsis, stress, and progression of systolic left ventricular dysfunction among others), arrhythmias, and mechanical cardiac complications. Cardiogenic shock in the absence of acute myocardial infarction (AMI) (non-AMI CS) is excluded from most studies including randomized trials and remains largely understudied. For many years, the intra-aortic balloon pump was thought to be helpful in improving outcomes in cardiogenic shock. However, the landmark randomized, controlled IABP-SHOCK II trial, published in 2012, and concluded that the use of intra-aortic balloon counter pulsation did not significantly reduce mortality in patients with cardiogenic shock complicating acute myocardial infarction. This led investigators to search for alternate temporary mechanical circulatory support systems that might prove effective in reducing mortality in cardiogenic shock. One such system is the Impella 5.0 and Impella RP devices. The Impella 5.0 pump in a temporary continuous flow pump approved for hemodynamic support for left ventricular shock CS patient and the Impella RP for right ventricular shock. The other system is the Tandem heart pump. The investigators utilize the Impella and the tandem pump for AMI CS and non-ischemic CS. The device is implanted for bridge to recovery, bridge to transplant and as a bridge to durable device. The investigators have discovered that recovery rates following AMI shock are significantly improved with the Impellaand tandem heart pumps however; identifying which patient recovers remains a mystery. Adequate parameters do not exist.
Patients who we are unable to recover are transitioned to a durable continuous flow left ventricular assist devices (CF-LVAD) which are an effective alternative to heart transplant, but are not risk-free: among the other effects, right ventricle (RV) hemodynamics are significantly altered by the LVAD implantation. In fact, RV failure occurs in 5% of patients with implanted CF-LVADs, and leads to a 6-fold increase in the risk of death. Moreover, RV failure is a major contributing factor in prolonged hospitalizations, and is associated with a higher risk of bleeding, renal failure, and hypotension. Currently, predictors of RV failure in patients undergoing LVAD implantation are based entirely on retrospective case series, often evaluating cohorts of patients with outdated classes of pulsatile-flow LVADs.Furthermore, right ventricular failure (RVF) still results as the major cause of morbidity and mortality after LVAD implantation. Despite overall improved outcomes and lower rates of RVF with the use of the newer, LVAD over pulsatile-flow devices, and development of clinical prediction scores to facilitate preoperative identification of patients at risk for RVF after implantation remains elusive. RVF occurs in 13% to 40% of continuous-flow device. The ability to predict the development of RV failure post LVAD implantation would significantly improve outcomes as these patients would either have planned RVAD implantation or receive a total artificial heart implantation.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiogenic Shock Patients Needing TMCS | – | Other: Measuring Pressure Volume Loop Pre and Post Device PlacementHeart failure patients who undergo TMCS insertion for acute decompensated heart failure and cardiogenic shock. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All cardiogenic shock patients requiring mechanical circulatory support devices can be enrolled in the study. The patients chart will be examined for possible exclusion by the PI or implanting surgeon who is also a co-investigator.
Key inclusion criteria (2 listed)
- All cardiogenic shock patients requiring temporary mechanical circulatory support (TMCS) (Impella, Tandem heart and ECMO). Age >=18
- -
Key exclusion criteria (3 listed)
- Age <18, All patients requiring ECRP
- Patients with a Mechanical Aortic Valve
- Patients with Left Ventricular Thrombus
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 |
|---|---|---|
| Measuring Pressure Volume Loop Pre and Post Device PlacementTo measure simultaneous pressure and volume of the heart (pressure volumes loops) before and after ventricular assist device placement for cardiogenic shock (a severe form of heart failure) and before and after device removal. | Other | Cardiogenic Shock Patients Needing TMCS |
Primary outcome
Ventricular Pressure Volume Loop Analysis
Time frame: Up to 90 days
Three Load independent Parameters will be measured and analyzed at three different time points. Pre, post implant and at explant
1 secondary outcome
Survival and device explant rate
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2020.
- Individual participant dataSharing planned: Undecided. At this time there are no plans to share individual participant data with other researchers
Related trials for Cardiogenic Shock
RecruitingObservational study
Cardiogenic Shock Working Group Registry
Cardiogenic Shock
RecruitingObservational study
Assessment of Support With Impella® Best Practices in Acute Myocardial Infarction Complicated by Cardiogenic Shock
AMI Cardiogenic Shock
Recruiting
CRP Apheresis in Infarct-Related Cardiogenic Shock
Cardiogenic Shock, Acute Myocardial Infarction (AMI)
RecruitingObservational study
Changes in Skeletal Muscle Thickness in Patients With Acute Heart Failure
Heart Failure, Muscle Atrophy
Recruiting
Routine Versus Provisional Distal Perfusion Catheter Placement in Patients Undergoing Mechanical Circulatory Support
Cardiogenic Shock, Acute Myocardial Infarction of Inferior Wall
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.
Danny Ramzy, MD principal investigator
Physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiogenic Shock and Decompensated Heart Failure, run by Cedars-Sinai Medical Center 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: status not confirmed, as of the sponsor's last update on 20 Jul 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Danny Ramzy, MD (310-423-1877, danny.ramzy@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventricular Pressure Volume Loop Analysis (time frame: Up to 90 days). 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 20 Jul 2020.