Tissue Doppler Assessment of Right Ventricular Performance in Acute Heeart Failure (TARVA)
|First Received Date ICMJE||December 27, 2007|
|Last Updated Date||January 31, 2017|
|Actual Start Date ICMJE||July 2006|
|Primary Completion Date||December 2013 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
||Surrogate marker of hemodynamic responses to therapy. [ Time Frame: Admission to ICU - 2 weeks post discharge ]
Correlation of peak systolic right ventricular strain with PCWP
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00589758 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Tissue Doppler Assessment of Right Ventricular Performance in Acute Heeart Failure|
|Official Title ICMJE||Tissue Doppler Assessment of Right Ventricular Performance in Acute Heeart Failure|
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.
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:
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 clinical trials.
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.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Biospecimen||Retention: Samples Without DNA
Blood and Urine
|Sampling Method||Probability Sample|
|Study Population||patients admitted to H22 ICU|
|Condition ICMJE||Cardiovascular Diseases|
|Study Groups/Cohorts||Acute Decompensated Heart Failure
Admitted to Heart Failure ICU for acute decompensated heart failure. 2D and 3D echocardiography will be obtained at baseline, 24 -48 hours and 1-2 weeks post discharge.
Blood and urine will be collected for biomarker evaluation at each timepoint
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||June 2014|
|Primary Completion Date||December 2013 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
|Ages||18 Years to 80 Years (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00589758|
|Other Study ID Numbers ICMJE||06-467|
|Has Data Monitoring Committee||No|
|U.S. FDA-regulated Product||
|Plan to Share Data||No|
|IPD Description||Not Provided|
|Responsible Party||The Cleveland Clinic|
|Study Sponsor ICMJE||The Cleveland Clinic|
|Collaborators ICMJE||Not Provided|
|PRS Account||The Cleveland Clinic|
|Verification Date||January 2017|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP