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A prospective, multi-national, open-label clinical study which is conducted to asses the safety, feasibility and performance of the TRVD™ System in hospital-admitted patients with Acute Decompensated Heart Failure (ADHF) and evidence of reduced left ventricular ejection fraction. The study will include patients who present with significant venous congestion, as evidenced by clinical, laboratory and imaging signs of fluid retention. Study participation, for each enrolled subject, will last approximately 3 months post index procedure. Patients will be evaluated from enrollment until hospital discharge, then at 30, 60, and 90 days post procedure.
In this study the investigators are aiming to treat patients with acute heart failure with or without diabetes with Empagliflozin or placebo. Given the beneficial effects of Empagliflozin on heart failure hospitalization in the EMPA-REG OUTCOME trial, the investigators do expect a similar beneficial effect to be present in patients with acute heart failure. Acute heart failure is a state of hydropic decompensation resulting in dyspnea and congestions, caused by different etiologies of cardiac disease. Recompensation is reached by application of diuretic drugs and fluid restriction.
This is a dissertation study which is divided into three different studies in order to answer the main research question (Study 3). The primary aim of this research (dissertation) is to investigate all-cause 30-day hospital readmission using functional mobility (5mWT, 30STS, 6MWT, TUG), psychosocial attributes (KCCQ-12, HADS, ESSI), adherence to home exercise program, participation in a supervised exercise program, and number of follow up checkups with physicians or advanced health providers of patients with Acute Decompensated Heart Failure (ADHF) diagnosis who were discharged from a tertiary teaching hospital. Study 1: What is the effect of acute physical therapy on functional ability in individuals admitted with ADHF? Study 2: What is the effect of acute physical therapy on psychosocial attributes in individuals admitted with ADHF? Study 3: Which factors such as functional mobility (5mWT, 30STS, 6MWT, TUG), psychosocial attributes (KCCQ-12, HADS, ESSI), adherence to home exercise program, participation in a supervised exercise program, and number of follow up checkups with physicians or advanced health providers predict all-cause 30-day hospital readmission in patients discharged from a tertiary, teaching hospital with ADHF diagnosis?
Cardiac surgery can be not infrequently complicated by cardiac low-output syndrome due to critical preoperative conditions such as cardiogenic shock, poor left ventricular function and severe myocardial ischemia. Suboptimal myocardial protection, technical errors at graft anastomoses or of prosthesis implantation, and hibernating myocardium may further contribute to cardiac low-output syndrome occurring immediately or shortly after cardiac surgery. In this setting, veno-arterial extracorporeal oxygenation (VA-ECMO) is the only means to provide cardiopulmonary support to recovery or as bridge to transplantation. Data on the real benefit of VA-ECMO after cardiac surgery is limited and often derived from heterogeneous patient populations, which prevent conclusive results on the benefits of VA-ECMO in this setting. This issue will be investigated in the present retrospective European multicenter study. In this setting, veno-arterial extracorporeal oxygenation (VA-ECMO) is the only means to provide cardiopulmonary support to recovery or as bridge to transplantation. Data on the real benefit of VA-ECMO after cardiac surgery is limited and often derived from heterogeneous populations of patients who underwent different cardiac procedures. Patients with cardiac low-output after surgery for aortic dissection or valve surgery are expected to have different baseline characteristics (such as age and comorbidities) and underlying cardiac disease than patients undergoing isolated coronary surgery. Furthermore, available studies included patients operated two decades ago and this does not provide an exact measure of the benefits of this treatment strategy. The possible benefits of using VA-ECMO after adult cardiac surgery will be investigated in this retrospective European multicenter study.
Vitamin K antagonists (VKAs) are used to reduce the risk of stroke (cerebral vascular dysfunction) in AF patients. However, VKAs interact with drugs/food and the drug level is influenced by worsening of renal function, liver congestion or hemodynamic alterations in acute decompensated heart failure (ADHF). New oral anticoagulants (rivaroxaban, apixaban, dabigatran) are alternatives to VKA, such as warfarin. In post hoc analysis of ROCKET AF trial, 63.7% patients had HF and treatment-related outcomes were similar in patients with and without HF (Circulation HF. 2013; 6:740-7). So rivaroxaban 20 mg daily (or 15 mg daily in patients with creatinine clearance 30-49 mL/min) was safe in nonvalvular AF patients with HF. However, the clinical effect and safety of rivaroxaban were largely unknown in acute decompensated heart failure (ADHF) patients with atrial fibrillation (AF). ROAD HF-AF is the exploratory study to assess the change of surrogate markers (hsTn, d-dimer) when treated with rivaroxaban vs. warfarin and to strengthen the basis for future biomarker-based therapy in ADHF patients
The AHF-CORE study is a prospective, non-randomized, multicenter regional study. The main objective of the AHF-CORE study is to identify congestion markers (clinical, biological and ultrasound) at the beginning and at the end of hospitalization for acute heart failure that are more strongly associated with the risk of all cause death or rehospitalization for acute heart failure within 3 months of hospital discharge. Secondary objectives are: - Quantify the variations in congestion markers between the beginning and end of hospitalization for acute heart failure. - Assess the correlation between changes in congestion markers between the beginning and end of hospitalization. - Identify the congestion markers at the beginning of hospitalization that are most strongly associated with residual congestion at the end of hospitalization. - Identify the added value of ultrasound and biological markers of congestion in addition to clinical variables for the prediction of all-cause death or hospitalization for acute heart failure at 3 months after hospital discharge.
The majority of the over one million annual AHF hospitalizations originate from the emergency department. Admitting and re-admitting lower risk AHF patients who don't need prolonged hospitalization may increase their risk for poor outcomes and decrease their quality of life: Safe alternatives to hospitalization from the ED are needed. We propose a strategy-of-care, short stay unit management of AHF (i.e. less than 24 hours), will lead to improved outcomes for lower risk AHF patients.
Acute heart failure is a life threatening condition requiring rapid diagnosis and treatment. However, the differentiation between heart failure and other conditions presenting with acute dyspnea is notoriously difficult in the emergency room. Point-of-care lung ultrasound is a simple, rapid and noninvasive technique directly visualizing fluid content in the lung as evidence for acute heart failure. A number of publications showed the diagnostic utility of lung ultrasound in the diagnosis of heart failure, but many open questions remain. The goal of this study is to evaluate the diagnostic accuracy of lung ultrasound to predict a cardiac origin of dyspnea in unselected patients in the emergency room as compared to standard evaluation. Further goals are to evaluate if lung ultrasound provides additional diagnostic information as compared to clinical examination, NT-proBNP and chest X-ray, to compare the diagnostic accuracy of lung ultrasound in different patient subgroups (heart failure with preserved vs reduced ejection fraction, de novo vs decompensated chronic heart failure, age ≥75 vs <75 years, women vs men and presence vs absence of concomitant pulmonary disease) and to compare demographics and clinical characteristics in different patient populations. 300 patients, aged ≥18 years presenting to the emergency room (ER) with acute dyspnoe as principal complaint will undergo initial clinical assessment of the likely etiology of dyspnea by the ER physician in charge. The second assessment by the same physician will include results of NT-proBNP according to predefined cutoffs. Final diagnosis ("Gold Standard") will be done by two experienced investigators after patient discharge taking into account the complete medical record except the results of lung ultrasound. Assessment of chest X-ray and lung ultrasound by investigators will be preforemd blinded regarding all other results.
Dynamic variations of bio-impedance measured cardiac output using pharmacologic (inhaled nitrate) and non pharmacologic intervention (sitting position, passive leg rising and valsalva maneuver) could be used to detect acute heart failure in patients admitted to the ED for dyspnea.
Safety and performance evaluation of the Doraya catheter in patients admitted with AHF.