Validating PROMIS Instruments in Congestive Heart Failure Patients Receiving a Heart Transplant...
Congestive Heart FailureThe Patient-Reported Outcomes Measurement Information System (PROMIS) is an NIH Roadmap initiative to develop a computerized system measuring patient-reported outcomes in respondents with a wide range of chronic diseases and demographic characteristics. In the first four years of its existence, the PROMIS network developed item banks for measuring patient-reported outcomes in the areas of pain, fatigue, emotional distress, physical function, and social functioning. During the item banking process, the PROMIS network conducted focus groups, individual cognitive interviews, and lexile (reading level) analyses to refine the meaning, clarity, and literacy demands of all items. The item banks were administered to over 20,000 respondents and calibrated using models based on item response theory (IRT). Using these IRT calibrations, computerized adaptive test (CAT) algorithms were developed and implemented. The network has designed a series of studies using clinical populations to evaluate the item attributes, examine their utility as CATs, and validate the item banks. More information on the PROMIS network can be found at www.nihpromis.org. The purpose of this research study is to learn about the experience and impact of having congestive heart failure (CHF). In particular, we hope to develop better questionnaires that can measure heart failure patients' quality-of-life.
Non-invasive Assessment of Liver Stiffness/Fibrosis by Transient Elastography (Fibroscan) in Patients...
Liver FibrosisHeart FailureThis study will involve 70 patients who attend the Alfred Hospital with acute or chronic heart failure as well as 30 age and gender matched control subjects. All participants will have their history taking and a physical examination to detect symptoms and signs of heart failure. The main objectives are for determining the benefit and usefulness of Fibroscan (Liver scan) in detecting liver stiffness (a condition caused by excess fluid build up in the liver which has a negative impact on the livers ability to function properly) in heart failure patients and for characterizing the incidence and severity of liver stiffness in this group of patients. After informed consent, a blood sample will be taken from all patients to assess their full blood examination, glucose, lipid profiles, renal function and so on. Then 24-48 hours after enrollment, the liver doctors will do the liver scan (Fibroscan) by transient elastography. All the data are recorded and further analysis will be assessed. In a small group of acute patients the blood tests and liver scan will be repeated just prior to their discharge. Optional Sub-study: For participants who consent to the optional sub-study another 20 ml of blood for serum liver fibrotic markers will be collected.
Echocardiography and Peak Endocardial Acceleration (PEA) Measurements in Cardiac Resynchronization...
Congestive Heart FailureThis study used an external endocardial acceleration sensor (sonR sensor), placed on the patient's chest, to time the closure of aortic and mitral valves, and compared its performance with echocardiography.
Evaluation of Multisensor Data in Heart Failure Patients With Implanted Devices
Heart FailureThe goal of the MultiSENSE study is to collect chronic information from multiple sensors in an implanted device for evaluation in heart failure patients.
Outpatient Lung Impedance-Guided Preventive Therapy in Patients With Chronic Heart Failure (CHF)...
Chronic Congestive Heart FailurePatients suffering from Chronic Heart Failure (CHF) are hospitalized for acute heart failure (AHF) several times a year. Currently, we have no method for prediction of future developments of AHF. In our center we have investigated the monitoring of lung impedence as a predictor for future deterioration. It was found that a decrease in lung impedence of more than 15% from normal value predicts AHF development with sensitivity of 98%. In this study we try to prove the hypothesis that preventive treatment according to lung impedence value may prevent future hospitalizations for AHF and improve clinical outcome. Patients recruited by year: 2011 - 50; 2012 - 25; 2013 - 35; 2014 - 30; 2015 - 50; 2016 - 5
Study of Left Ventricular Dyssynchrony in Heart Failure Patients
Heart FailureHeart failure has become one of the major epidemics of the modern era. Despite optimal standard drug therapy, the prognosis of patients with heart failure remains poor. Patient with Heart Failure are prone to have "dyssynchrony" which means that there are electrical disturbances that cause the heart to pump blood in an inefficient way. Ventricular dyssynchrony has been associated with increased mortality in patients with heart failure. Based on these observations, techniques have been developed to correct dyssynchrony. The investigators propose to investigate the change of dyssynchrony in relation to intravascular volume status and exercise in heart failure patients. The investigators also propose to examine dyssynchrony in the setting of acutely decompensated heart failure. The change in dyssynchrony will be followed to examine if it translates into clinical significance.
SJ4 Post Approval Study in Implantable Cardioverter-Defibrillator and Cardiac Resynchronization...
TachyarrhythmiasSudden Cardiac Death1 moreThe purpose of this study is to characterize the chronic performance of the St. Jude Medical SJ4 connector and RV high voltage SJ4 leads.
EnSite Real-Time Cardiac Performance Measurements (RT CPM) Study
Heart FailureThe EnSite Real-Time Cardiac Performance Measurements Study (EnSite RT CPM) is a multicenter, international, acute, non-significant risk study, designed to enroll a maximum of 40 patient. The goal of the study is to collect 3-D systolic/diastolic data with the EnSite NavX Mapping system during a CRT implant. Patients enrolled in this study will undergo NavX CPM recording of the heart using the EnSite NavX Mapping system during the implantation of a cardiac resynchronization therapy device.
Use of Defibrillator Information in the Emergency Department
Congestive Heart FailureMedical DeviceThis is a study to determine the feasibility of obtaining information stored in existing Medtronic internal defibrillators in patients who present to the Emergency Department(ED) for any reason. In addition, the study will determine if this information is useful to the ED physician in managing the patient's care, specifically as it relates to heart failure.
Observational Usage and Efficacy Study of Candesartan in Heart Failure Treatment in France
Heart FailureCohort StudyThe purpose of this study is to describe the way candesartan is used in heart failure treatment in France (treatment initiation and monitoring), treatment stops occurrence and reasons for and patients clinical evolution