Tissue Doppler Assessment of Right Ventricular Performance in Acute Heeart Failure (TARVA)

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.