
A Method Validation Study for Evaluation of Novel Treatments Limiting Pulmonary Oedema in Cardiac...
Heart FailureCongestiveTransient receptor potential vanilloid 4 (TRPV4) channel blockade may be promising in the treatment of pulmonary oedema and dyspnoea in heart failure (HF) and acute decompensated heart failure (ADHF) patients by re-establishing the alveolar septal barrier. Dynamic contrast enhanced (DCE) Magnetic Resonance Imaging (MRI) is an established technique for assessing changes in vascular permeability and interstitial water volume. The aim of this study is to establish the potential utility of DCE-MRI as a novel endpoint for dose ranging and proof of mechanism studies of TRPV4 blockers. The DCE-MRI markers of vascular permeability and pulmonary oedema will be measured in subjects with HF (group 2) and healthy volunteers (HV) (group 1) at rest to determine if there is a difference between the two populations. Apart from this, exercise induced changes relative to rest in interstitial volume and exchange rate will be evaluated in both HV and subjects with HF. Additionally, the capability of DCE-MRI to detect changes in interstitial lung fluid in patients with acute decompensated heart failure (ADHF) (group 3) will be investigated. DCE-MRI markers of pulmonary oedema will be assessed when patients are initially hospitalized with ADHF and subsequently after receiving standard of care treatment to determine whether differences can be detected by this methodology.This study will enrol a sufficient number of subjects to have at least 24 subjects in Group 1 and 2 (group 1:12 HV and group 2: 12 subjects with HF) and atleast 5 subjects in Group 3. For each subject, the MRI data must be of sufficient quality to enable DCE-MRI modelling from 2 Sessions. For group 1 and 2, the subjects will have screening visit and 3 MRI sessions. For the first scanning session, subjects will undergo the baseline procedure. The second imaging session will occur approximately one week later to measure within subject variability. A third imaging session (which will be conducted in 2 visits) will incorporate a bicycle exercise challenge prior to the MRI scan, and this third scan will be performed approximately one to three days after the second imaging session. For group 3: Screening will occur during hospitalization for eligibility. Session 1of MRI will be conducted while the subject is still hospitalized. Session 2 will be conducted within 4 weeks of the first scan, when the signs of pulmonary oedema are considered to be resolved. If a subject's pulmonary oedema has not resolved at Session 2, then the subject will be not be scanned by MRI at Session 2 and will be brought back for Session 3 up to 4 weeks after Session 2 for their second MRI.

Levosimendan Administration and Outcome in Cardiac Surgery
Treatment of Left Heart Insufficiency in an Operative Setting of Cardiac SurgeryTo assess the effects on outcome of levosimendan with respect to timing of its administration on the postoperative course of high-risk cardiac surgery patients in a retrospective observational study.

How the Elderly Live With Pain in Heart Failure
Heart FailureThe How the Elderly Live with Pain in Heart Failure (HELP-HF) study provides the opportunity to assess the complaints of pain in a cohort of HF patient admitted to Thomas Jefferson University Hospital (TJUH). Additional information on their existing co-morbid conditions, an inventory of their prescribed medications, and details regarding the type of treatment interventions (over the counter analgesia and other comfort practices) they report using will be collected.

Cardiac Resynchronization Therapy Modular Registry
Heart FailureThe purpose of the study is to collect some parameters (clinical, electrical, radiographic, echocardiographic and ECG) able to predict response to cardiac resynchronization therapy.

Selected Site Pacing to Avoid Phrenic Nerve Stimulation in Cardiac Resynchronization Patients With...
Heart FailureCardiac resynchronization (CRT) therapy is well established for treatment of patients with severe heartfailure, reduced left ventricular (LV) function and ventricular dyssynchrony. Roughly 1/3 of CRT patients do not improve after CRT implant. One possible reason is interruption of biventricular pacing. This might be caused by several conditions, including elevated left ventricular (LV) pacing thresholds or presence of phrenic nerve stimulation (PNS). CRT devices with quadripolar LV leads offer 10 LV pacing vectors to choose from. It's the aim of this prospective observational study to investigate efficacy and reliability of cardiac resynchronization therapy (CRT) with quadripolar left ventricular leads. Hypothesis: In more than 90% of patients, who received a CRT system with quadripolar LV lead, at least one acceptable LV lead vector is available.

CARE-HF Long Term Follow-up
Heart FailureThe CARE-HF long-term follow-up trial evaluates the effects of cardiac resynchronization (CR) therapy on the mortality of patients from the CARE-HF program for an additional 4 year follow-up. Investigators are free to choose whatever available treatment they believe is in the patient's best interest.

Home Monitoring in Cardiac Resynchronisation Therapy
Heart FailureCongestiveIn spite of success in the management of heart failure, repetitive rehospitalisation and high mortality rate remain a serious problem. Recent studies, especially the COMPANION trial, have demonstrated that cardiac resynchronisation therapy (CRT) reduces mortality and rehospitalisation in heart failure patients. There is also evidence that telemonitoring of heart failure patients potentially reduces both mortality and morbidity. Recently, a Home Monitoring (HM) function has been integrated into BIOTRONIK CRT-defibrillators and CRT-pacemakers with a view of harnessing the powerful combination of CRT with close remote monitoring of heart failure patients. It is possible now to transmit predefined parameters on a daily basis from the implanted devices to a web-based platform accessible by patients' physicians. Our study evaluates clinical usefulness of Biotronik HM function in CRT-defibrillators and CRT-pacemakers.

Anticipatory & Preventive Team Care (APTCare): At Risk Patients of Family Health Networks
DiabetesChronic Obstructive Pulmonary Disease2 moreThe University of Ottawa and Élisabeth Bruyère Research Institute are conducting a study of preventive care for frail patients at risk of functional decline. At risk patients are assigned by chance to continue receiving their standard care from their family physician or receive additional care from a nurse practitioners and a pharmacist. In collaboration with the family physician, they develop an individualized care plan, a treatment and management road plan, for each patient, which they implement over the study period of one approximately year. The objective of the study is to compare the effectiveness of the model of care that includes the nurse practitioners and pharmacist against standard care in preventing functional decline, to determine the acceptability of this model of care to patients, their caregivers and the medical team, and to evaluate the cost implication of the program.

A Culturally Sensitive Values-Guided Aid for End of Life Decision-Making
Congestive Heart FailureChronic Obstructive Pulmonary Disease4 moreThe goal of this research agenda is to improve the quality of end-of-life care by explicitly identifying values that will guide the decision-making process, with a particular emphasis on the role of ethnic, racial and cultural factors.

Sleep Apnea, Arrhythmias and Cardiac Reverse Remodeling in Heart Failure Patients
Sleep Breathing Disorders in the Responders to Cardiac Resynchronisation Therapy (CRT)Prospective, international, non-randomized, multicentre, clinical investigation (phase IV). The aim of the study is to investigate the correlation between HF, severe SBD, and AF in CRT-P patients at 6 months.