Active clinical trials for "Heart Failure"

Introduction: Heart Failure (HF) generates multiple hospital admissions and mortality, which are reduced with the administration of Beta-Blocker (BB), Angiotensin Converting Enzyme Inhibitor (ACEI), Angiotensin II Receptor Blocker (ARB) and Mineralocorticoid Receptor Antagonist (MRA) drugs (Level of Evidence A). The effect is dose-dependent. Nevertheless, dosages are suboptimal. European Guidelines 2012 recommend close monitoring and up-titration of drugs by HF nurses. Trials are needed to evaluate their effectiveness and safety. Objective: To compare doses achieved by patients of BB, ACEI, ARB II and MRA in 4 months ( % relative to target doses) in the intervention group (HF nurse) and in the control group ( cardiologist), adverse events, Left Ventricular Ejection Fraction (LVEF), New York Heart Association (NYHA), 6 min. walking test, quality of life, Nt-proBNP, readmissions and mortality. Hypothesis: Non-inferiority. Design: Multicenter randomized controlled trial. New ("de novo") HF patients with LVEF ≤ 40%, NYHA II-III, without contraindications to BB of 17 Spanish hospitals will be included. Intervention: The cardiologist prescribes drugs and, driven by protocol, the HF nurse implements the up-titration. In the control group doses are decided by the cardiologist clinical support and education being provided by nurses. Variables: age, sex, education, psycho-social level, Cardio Vascular Risk Factors (CVRF), NYHA, LVEF, ischemic cardiopathy., N-terminal pro B-type natriuretic peptide (Nt-proBNP), 6min. walking test, Creatinine/Glomerular Filtration Rate (GFR), Potassium (K), haemoglobin, Blood Pressure (BP), Heart Rate (HR), mg./drug, European Heart Failure Self-Care Behaviour Scale (EHFScBS), Minnesota Living with Heart Failure questionnaire (MLHFQ), European Quality of life Scale (EQ-5D). Expected Results: If our hypothesis were confirmed, evidence would be provided on the effectiveness of this healthcare management, that could be economically evaluated in future studies. A qualitative study also will be undertaken to explore barriers and facilitators to implementation

Despite the development of significant pharmaceutical treatments, morbidity and mortality of chronic heart failure (CHF) patients remain high, patients� quality of life is poor, and their health care utilization is heavy. It is therefore important to find a cost effective non-pharmaceutical treatment to help CHF patients manage the disease. The relaxation response has been found to be effective in managing CHF-related conditions. With its favorable physiological changes, the relaxation response is likely to benefit CHF patients.

Patients with heart failure are limited in their exercise capacity due to skeletal muscle alteration and an impairment of peripheral perfusion. Regular physical exercise training has been shown to partially correct these peripheral maladaptations in patients with stable heart failure, which was associated with an improvement in exercise capacity. However, it is unknown so far, whether regular physical activity also exerts beneficial effects in patients with severe chronic heart failure. Aim of the trial is therefore to assess the effects of aerobic exercise training on exercise capacity, muscle maladaptations and peripheral perfusion in patients with severe chronic heart failure according to NYHA class III b.

The goal of this study is to determine the effect of a functional circuit training program as compared to standard cardiac rehabilitation or control exercise in improving physical function and activity.

Growing recognition of the importance of co-morbidities in Heart Failure with Preserved Ejection Fraction (HFPEF) has led to the realization that rather than being a distinct disease entity, HFPEF may represent a spectrum of co-morbidities in elderly breathless patients. Accordingly, progress in managing HFPEF in the elderly requires improved understanding of HFPEF pathogenesis with a focus on the impact of co-morbidities. However, the available evidence is insufficient to determine the true prevalence and severity of co-morbidities as well as their impact on both diagnosis and treatment in HFPEF. Therefore there are widespread diagnostic uncertainty without proven therapy! The purpose of this project is twofold: The investigators will study how to improve diagnostic accuracy for HFPEF in elderly patients, despite frequent comorbidities and higher age? How useful is it to add exercise testing and contrast echocardiography as well as biomarker as additional diagnostic tools in elderly HFPEF patients? The investigators will test the hypothesis that HFPEF in the elderly is dominated by multiple co-morbidities that are a major part of the syndrome itself that contribute to the development of HFPEF. This hypothesis implies that the treatment of co-morbidities will improve prognosis. The investigators' overall goal is to bring about a paradigm shift in managing elderly patients with HFPEF by not only improving diagnosis but also effectively treating co-morbidities that are currently considered predisposing factors to HFPEF. This contrasts with trials during last two decades that only target the heart. The investigators will pursue the following specific aims: Validate the diagnostic criteria for HFPEF proposed by European Society of Cardiology 2012, and determine the added diagnostic values of exercise testing and contrast echocardiography as well as biomarker for HFPEF in a multi-center study. Determine if systematic screening and optimal management of co-morbidities associated with HFPEF improves the outcomes of patients with HFPEF in a randomized study.

The objective of ESCAPE-SCD Study is assessment of the effect of sleep apnea on sudden cardiac death risk and cardiovascular outcomes in patients with ischemic cardiomyopathy. The ESCAPE - SCD Study will address following specific study questions: Is obstructive sleep apnea (OSA) and/or central sleep apnea (CSA) an independent risk factor of sudden cardiac death (SCD) in patients with ischemic cardiomyopathy (ICM) indicated for ICD/CRT-D implant based on current European Society of Cardiology (ESC) Guidelines for primary prevention of sudden cardiac death? Can treatment of predominant (>50%) obstructive sleep apnea by appropriate Positive Airway Pressure (PAP) therapy decrease risk of sudden cardiac arrhythmic death in ICM patients? Can treatment of predominant (>50%) obstructive sleep apnea by appropriate PAP therapy improve cardiovascular outcomes in ICM patients indicated for ICD/CRT-D implant? Does obstructive sleep apnea represent a novel factor that may improve risk stratification of sudden cardiac death and advance identification of those patients that will benefit from ICD/CRT-D therapy?

Management of chronic heart failure (CHF) is a major public health problem. It is associated with high mortality, frequent hospitalization and represents a large cost to the health care system. Both pharmacological and non-pharmacological intervention haven't shown to be effective in reducing morbidity and mortality of these patients when able to modulate the activity of neuro-hormonal systems among them the sympathetic nervous system. Recent data have emphasized the potential role of sympathetic renal denervation in patient with hypertension. CHF per se but even more CHF associated with comorbity lead to significant increase level of sympathetic tone. This is largely induced by autonomic dysfunction such as chemo or baroflex abnormalities. These patients usually suffer from conditions which do not allow upgrading and adapting drugs to their sympathetic condition. Hence CHF patient with chronic kidney disease, anemia or both have markedly high sympathetic activity and cannot be exposed to higher level of RAS Blockers or beta blocker due to their renal dysfunction, they thus remain with an elevated sympathetic activity worsening symptoms and prognosis. Chronic heart failure affects around 100 million people worldwild imposing a significant burden on health care system throughout the world. Even though symptoms are improved by heart failure therapy, they remain significantly disabling for many patients. Chronic over activation of the sympathetic nervous system is a major component of heart failure and involves efferent and afferent pathways between brain and many organs. A new therapy directly targeting nerve traffic-renal artery denervation- has been shown to be effective in drug resistant hypertension, with an average drop in blood pressure of 33/12 mm hg. The cardiologists team of the private hospital Arnault Tzanck is willing therefore to conduct a study in 12 patients with chronic systolic heart failure undergoing bilateral renal denervation with an intensive protocol of observation and assessment compring a 3 day hospital stay post procedure 3 and 6 months of regular outpatient follow-up.

Atrial fibrillation (AF) and congestive heart failure (CHF) are two epidemics that share several physiopathological links. CHF patients present a significantly increased risk of developing AF and the related detrimental hemodynamic effects are even more relevant than in patients without CHF. Within CHF patients rate control is the most widely used strategy to manage AF, having proved non-inferior to rhythm control strategies. However, by this strategy, the hemodynamic effects of AF persist, not contrasting the natural evolution towards progressive left ventricular (LV) function, cardiac output , and symptoms worsening. Rhythm control strategy, instead, has shown, in the general population, advantages over rate control concerning survival, quality of life and thromboembolic events. The main limitation is that antiarrhythmic therapy used to achieve this goal has several side effects, and that transcatheter AF ablation has been assessed only in modest sample size studies. Available literature focusing on a direct comparison between two specific management strategies in patients with CHF and AF is limited to a small randomized study comparing pulmonary veins isolation to AV node ablation and biventricular PM implantation (PABA-CHF study). Additional indirect evidences may derive from meta-analyses of observational studies. The investigators therefore designed this multicenter, randomized controlled trial aiming to assess if, in recently diagnosed (less than 6 months) and optimally treated CHF patients with impaired LV function, AF catheter ablation is effective in improving LV function and clinical functional class, potentially driving to a reduction of device implantations (ICD/CRTs).

The prevalence of heart failure is estimated to 2.3 percent of the adult population and strongly increases with age, according to french disability-health surveys. In France, more than 32,000 annual deaths are attributable to heart failure and the five-year survival rate is similar to those found in many cancers. A better therapeutic management (angiotensin converting enzyme inhibitor and beta-blockers) helped reduce mortality after an episode of heart failure requiring hospitalization, but, nevertheless it remains high. The severity of cardiogenic pulmonary edema depends on several factors such as etiology, hemodynamic status, effect on hematosis, and fatigue. It is important to note that cardiogenic pulmonary edema initial management is decisive. In addition, early and adapted management of cardiogenic pulmonary edema is associated with a shorter hospital stay and reduced hospital mortality. The Coronary Emergency Network (RESURCOR) within the Northern French Alps Emergency Network (RENAU) is an emergency care system structured in the departments of Isère, Savoie and Haute Savoie. Its main goal is to help improve emergency management by using regional good practice guidelines (www.renau.org). In this context, projects aiming to evaluate professional practices are developed regularly. Since emergency management of cardiogenic pulmonary edema has not been evaluated, the Northern French Alps Emergency Network offers an approach to improve professional practices by defining and disseminating guidelines on cardiogenic pulmonary edema management which will then be assessed.

The aim of the study is to evaluate the impact of cryoablation of atrial fibrillation in patients with severe chronic heart failure (CHF) on long term outcome of CHF and efficacy (endurance) of the procedure itself. The study hypothesis is that cryoablation in eligible patients with CHF and ICD/CRT (implantable cardioverter defibrillator / cardiac resynchronization therapy) implants reduce the number of recurrent CHF hospitalizations, mortality, need for mechanical support of LV (left ventricle) and heart transplant (primary endpoint) at 1 year observation in comparison to traditional (pharmacological) treatment..