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
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
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.
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:
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
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.
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.
- admission to H-22 with Acute Decompensated Heart Failure
- clinical indication for PAC placement
- pericardial constriction or tamponage on echo or by other imaging modality
- status post cardiac transplantation
- inability to provide informed consent or unable or unwilling to follow protocol