Tissue Doppler Assessment of Right Ventricular Performance in Acute Heeart Failure
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Observational

Summary: 
      The primary purpose of this study is to learn if taking pictures of your heart using two
      dimensional and three dimensional echocardiography in the heart failure intensive care unit
      can be helpful to understanding how the heart is working.

      All research subjects will be adults admitted to the heart failure ICU with acute
      decompensated heart failure and requiring monitoring of their heart function using a catheter
      that is placed in the pulmonary artery which is a blood vessel. In this situation, use of the
      pulmonary artery catheter,or PAC, is considered standard clinical care. It is not a research
      procedure. The PAC would be used even if you were not participating in this research project.

      All research subjects will be evaluated at the time they are admitted to the ICU, 24 to 48
      hours after admission to the ICU, and 7 days after leaving the ICU. At all three time points,
      we will be taking pictures of the heart using the two dimensional and three dimensional
      echocardiogram.

      Additionally, at each time-point, we will collect a blood sample of approximately two and a
      half tablespoons each time, and a urine sample. We will be testing the sample for biomarkers
      of heart failure which are proteins and enzymes specifically related to heart function. We
      will not be conducting any genetic research on the sample. Any extra blood from these
      research tests will not be saved for future research.

      We will also be looking at the data that is collected by the pulmonary artery catheter. The
      catheter has a sensor on it that measures things like blood flow and pressure in the heart.

      At the Day 7 post discharge visit there will be a six minute hall walk so that we can access
      the distance that you can walk. We will access any symptoms that you may experience. A nurse
      or physician will monitor the six minute hall walk.

      The research information that we collect on you will not be placed in your medical record.
      The data is for research purposes only.
    

Detailed description: 
      Study Design This is a single-center, prospective cohort study. The project will be carried
      out at the Main Campus of the Cleveland Clinic Foundation. Comprehensive transthoracic
      echocardiography will be performed in the Heart Failure Intensive Care Unit at the Cleveland
      Clinic Foundation. This is an eight bed intensive care unit dedicated to treating patients
      with acute clinical issues related to heart failure and is staffed by heart failure
      specialists, medical officers and nurses specializing in heart failure management.

      Therapy will be individualized per patient and will be entirely at the discretion of the
      patients' cardiologist under the standard of care. Nevertheless, the Heart Failure Intensive
      Care Unit has standard drug protocols for intravenous vasodilators such as nitroglycerin and
      sodium nitroprusside, as well as inotropic therapy such as dobutamine and or milrinone, and
      pressors such as norepinephrine and or vasopressin. Based on the hemodynamic assessment using
      PAC, diuretics and vasodilators will be the first-line agents, followed by inotropic agents.
      Oral vasodilators will be instituted following a standard protocol. All medications and their
      doses will be noted at the time of each echocardiographic evaluation.

      The schedule will be as follows:

        1. The first echo will be performed within 24 hours of PAC insertion. Preferably at the
           time of or prior to commencing treatment in the Heart Failure Intensive Care unit.

        2. The second echo will be performed 24-72 hours after baseline echo in the Heart Failure
           Intensive Care unit.

        3. The third echo will be performed at the time of the scheduled outpatient visit after
           hospital discharge. The tests will be performed in the General Clinical Research Center
           which is an outpatient visit located on the fifth floor of the M building or at
           Cardiology Desk F-17.

      Timeline for individual patients:

      Data Extraction

      Invasive Hemodynamics:

      All patients will have a PAC inserted, usually via right jugular venous approach, for a
      clinical indication prior to recruitment This is required for inclusion into the study. Data
      collected at baseline and at the time of second echo will include systolic and diastolic
      blood pressures, heart rate and rhythm, central venous pressure, systolic and mean pulmonary
      artery pressures, pulmonary capillary wedge pressure, cardiac output and index by Fick
      equation, calculated cardiac power, systemic and pulmonary vascular resistance, and
      transpulmonary gradient. Thermodilution derived RV ejection fraction can also be performed. A
      dedicated hemodynamic database capturing all the above mentioned variables has already been
      designed and implemented for routine clinical use in the Heart Failure Intensive Care Unit.
      Since this is an observational study, it can be performed in concurrent with other clinical
      trials.

      Echocardiographic studies:

      All echocardiograms will be performed on an ultrasound machine capable of two dimensional
      echocardiograms with strain imaging using the GE Vivid 7 machine and three dimensional
      echocardiograms using the GE Vivid 7 machine or Phillips ultrasound machine.

      Each patient will undergo echocardiographic assessment with a standard ultrasound machine
      equipped with a 3.5 MHz transducer and capable of digital image storage. All echocardiograms
      will be performed on an ultrasound machine at the bedside, capable of two dimensional
      echocardiography with strain imaging using GE Vivid 7machine, and three dimensional
      echocardiography using the GE Vivid 7 machine or Phillips ultrasound machine. The reason for
      the broad range of study periods is to allow flexibility of performing echocardiography to
      fit into the patients' treatment plan in the Heart Failure Intensive Care Unit. Our
      experience in conducting this kind of study in the Heart Failure Intensive Care Unit has led
      us to believe that having a range of times is often helpful. Patients admitted overnight or
      in the weekends, without compromising the objectives of the study. Since the objective of the
      study is to determine the role of serial echocardiographic parameters with or without
      hemodynamic data in predicting the need for more invasive interventions or correlating with
      treatment responses to infusions, this design is close to "real-world" logistics and will
      unlikely affect study results.

      Patients will be placed in the left lateral decubitus position. When this is not possible
      such as when a patient is on a ventilator, modified views will be obtained. Standard
      parasternal long and short axis as well as standard apical four, three and two chamber views
      will be obtained. Subcostal images will be acquired when possible. The echocardiogram will
      include assessment of left and right ventricular systolic and diastolic function and valvular
      function. Assessment of systolic function will include: left ventricular end-systolic and
      end-diastolic diameters, left ventricular outflow tract diameter, left ventricular volumes,
      pulsed Doppler of Left ventricular outflow tract. Biplane left ventricular ejection fraction,
      stroke volume, cardiac output and index will then be calculated. Right-sided measurements
      will include, right ventricular end diastolic and systolic areas, pulse wave Doppler of the
      tricuspid valve. Strain will be acquired in all views along with pulse wave tissue Doppler of
      left and right ventricular annuli.

      Cardiac Biomarkers:

      A total of 40cc blood sample collection in plasma (20cc) and serum (20cc) will be collected
      at each echo study, and will be processed and aliquotted within 2 hours at the GCRC core lab.
      Biomarkers of interest include: (1) plasma B-type natriuretic peptide at every visit, (2)
      cardiac troponin T at baseline, (3) high-sensitive C-reactive protein (hsCRP) at baseline,
      will be sent to the clinical laboratory for analysis. Extra blood will be collected at every
      visit and stored in -80F freezer for other research-based novel biomarkers, all subject to
      availability of supplementary external research funding.

      Six minute hall walk Standard Six minute hall walk will be performed to assess functional
      capacity only at the GCRC follow-up visit.
    

Intervention name(s): Echocardiography; Biomarker evaluation
Intervention type(s): Diagnostic Test; Other
Intervention description(s): 2D and 3D echocardiography; Blood and urine collected
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients admitted to H22 ICU
      
Biospecimen description: 
      Blood and Urine
    
Keywords: Right Ventricle; Echocardiogram; Evaluation of Heart Failure