Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 10:03 PM
Study NCT ID:
NCT00589758
Status:
COMPLETED
Last Update Posted:
2017-02-01
First Post:
2007-12-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Tissue Doppler Assessment of Right Ventricular Performance in Acute Heeart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004452', 'term': 'Echocardiography'}], 'ancestors': [{'id': 'D057791', 'term': 'Cardiac Imaging Techniques'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood and Urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-31', 'studyFirstSubmitDate': '2007-12-27', 'studyFirstSubmitQcDate': '2007-12-27', 'lastUpdatePostDateStruct': {'date': '2017-02-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surrogate marker of hemodynamic responses to therapy.', 'timeFrame': 'Admission to ICU - 2 weeks post discharge', 'description': 'Correlation of peak systolic right ventricular strain with PCWP'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Right Ventricle', 'Echocardiogram', 'Evaluation of Heart Failure'], 'conditions': ['Cardiovascular Diseases']}, 'descriptionModule': {'briefSummary': '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.\n\nAll 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.\n\nAll 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.\n\nAdditionally, 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.\n\nWe 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.\n\nAt 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.\n\nThe research information that we collect on you will not be placed in your medical record. The data is for research purposes only.', 'detailedDescription': '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.\n\nTherapy 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.\n\nThe schedule will be as follows:\n\n1. 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.\n2. The second echo will be performed 24-72 hours after baseline echo in the Heart Failure Intensive Care unit.\n3. 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.\n\nTimeline for individual patients:\n\nData Extraction\n\nInvasive Hemodynamics:\n\nAll 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.\n\nEchocardiographic studies:\n\nAll 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.\n\nEach 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.\n\nPatients 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.\n\nCardiac Biomarkers:\n\nA 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.\n\nSix minute hall walk Standard Six minute hall walk will be performed to assess functional capacity only at the GCRC follow-up visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients admitted to H22 ICU', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* admission to H-22 with Acute Decompensated Heart Failure\n* clinical indication for PAC placement\n\nExclusion Criteria:\n\n* pericardial constriction or tamponage on echo or by other imaging modality\n* status post cardiac transplantation\n* inability to provide informed consent or unable or unwilling to follow protocol'}, 'identificationModule': {'nctId': 'NCT00589758', 'acronym': 'TARVA', 'briefTitle': 'Tissue Doppler Assessment of Right Ventricular Performance in Acute Heeart Failure', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': 'Tissue Doppler Assessment of Right Ventricular Performance in Acute Heeart Failure', 'orgStudyIdInfo': {'id': '06-467'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Acute Decompensated Heart Failure', 'description': '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.\n\nBlood and urine will be collected for biomarker evaluation at each timepoint', 'interventionNames': ['Diagnostic Test: Echocardiography', 'Other: Biomarker evaluation']}], 'interventions': [{'name': 'Echocardiography', 'type': 'DIAGNOSTIC_TEST', 'description': '2D and 3D echocardiography', 'armGroupLabels': ['Acute Decompensated Heart Failure']}, {'name': 'Biomarker evaluation', 'type': 'OTHER', 'description': 'Blood and urine collected', 'armGroupLabels': ['Acute Decompensated Heart Failure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'James Thomas, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}