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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.

Danny Ramzy, MD contact

310-423-1877

danny.ramzy@cshs.org

Soheila Abbassi, MBA contact

310-423-5086

soheila.abbassi@cshs.org

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

Other trials in United States

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.

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 groups in NCT04478188
Study groupRoleWhat they receive
Cardiogenic Shock Patients Needing TMCSHeart 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.

  1. 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)
  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.

  1. First posted20 Jul 2020
  2. Study startAug 2020 (estimated)
  3. Primary completionJul 2021 (estimated)
  4. Study completionJul 2023 (estimated)

Resources

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)
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

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.

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