View clinical trials related to Heart Failure.
Filter by:Rationale: Prolongation of the electrocardiographic PR interval (PR interval > 200ms; also known as first-degree atrioventricular block) is frequently encountered in clinical practice and is generally considered as a benign sign. However, there is increasing evidence that a prolonged PR interval results in poor hemodynamic performance with elevated left ventricular (LV) end-diastolic pressures evidenced by diastolic mitral regurgitation. Previous studies have also associated a prolonged PR interval with a substantially increased risk of future atrial fibrillation (AF) and pacemaker-implantation, and increased risk of heart failure (HF) hospitalization and death. These risks stress the importance of proper atrioventricular (AV) coupling. Shortening of the PR interval may be especially important in heart failure patients and can be obtained by atrioventricular pacing. A possible adverse effect of ventricular pacing is that it results in ventricular dyssynchrony which may lead to worsening cardiac function. This effect may be prevented by applying atrio-biventricular pacing. Data from several previous (sub)studies have suggested this. Objective: The purpose of this study is to investigate the acute hemodynamic effects of restoration of atrioventricular coupling by atrio-biventricular pacing in patients with heart failure and prolonged PR interval. Study design: This study will be a multi-center, exploratory, prospective interventional, nonrandomized acute hemodynamic study, using patients as their own controls. Study population: The study will enroll 26 patients with symptomatic heart failure, reduced left ventricular ejection fraction (LVEF) (< 35%) and prolonged PR interval (>230ms), but without seriously prolonged QRS duration (<150ms) or left bundle branch block (LBBB) QRS pattern, who are candidates for an implantable cardioverter defibrillator (ICD) device according to current guidelines. Main study parameters/endpoints: The main study parameter will be the acute hemodynamic change in left ventricular stroke work (SW) during atrioventricular optimization by atrio-biventricular pacing. Secondary parameters will be the acute hemodynamic changes in left ventricular dP/dt|max and left ventricular stroke volume (SV) by invasive measurements and in left ventricular stroke volume, diastolic mitral regurgitation and left ventricular diastolic filling time by echocardiography during atrioventricular optimization by atrio-biventricular pacing. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The patients are candidates for an ICD device in whom cardiac resynchronization therapy (CRT) can be considered according to current guidelines. Patients in the present study will receive a CRT-defibrillator (CRT-D). The risk and/or complications of the CRT-D implantation are not additional for this study. After the implantation, acute invasive hemodynamic measurements will be performed with a pressure-volume catheter, which is inserted via the femoral artery and adds approximately 30 minutes to the standard procedure. An extra radiation dose of approximately 50mGy is needed to place the pressure volume catheter in the LV cavity. Local vascular complications of femoral artery puncture like bleeding or damage to the vessel wall may occur but are rare. The non-invasive echocardiographic protocol one to two weeks after implantation will add approximately 45 minutes to the routine outpatient clinic visit. The patients do not have to visit the clinic outside the routine outpatient clinic visits before and after a CRT-D implantation. The patients will have the potential direct benefit from the procedure, by finding the patient's specific optimal (atrioventricular) settings and thereby reducing above described risks of a prolonged PR interval. In case of a worse hemodynamic performance due to the procedure, the CRT-D will be programmed to back up pacing and there is no harm for the patient outside the above subscribed extra measurements.
The OPTIMIZER Smart Post-Approval Study is a prospective, multi-center, non-randomized, single arm open label study of 620 subjects receiving an OPTIMIZER implant as standard of care. Patients to be included will have NYHA functional class III symptoms and a left ventricular ejection fraction of 25-45%
The objectives are 1. to validate quantification of 2D and 3D right ventricular strian measurements of right ventricular performance in cross comparison to cardiac MRI and to evaluate its relation to right ventricular fibrosis. 2. to evaluate their prognostic value in patients with heart failure with either depressed or preserved ejection fraction.
Cachexia is a very common condition in patients with advanced heart failure (HF) and is considered a predictor of mortality. Studies have been carried out in an attempt to discover the mechanisms that leads to cachexia in order to improve the therapies and the survival of these patients. Some of these studies give the hypothesis that the gastrointestinal tract, more precisely the intestine, can collaborate with cachexia. Some of these studies suggest that, the intestinal mucosa, due to hypoperfusion, becomes more permeable to some substances, as like endotoxins, being the lipopolysaccharide (LPS) one of them. The circulating LPS can stimulate the increase of tumor necrosis alpha (TNF-alpha) further increasing the inflammation and, consequently, contributing to the worsening of prognosis. The intestinal microbiota is also affected by hypoperfusion, contributing with increase of permeability. As known, probiotics can help to maintain or recover the microbiota and maintain a healthy intestinal barrier. In view of the importance of microbiota to inflammation in the prognosis of the patients and the performance of microbiota in maintenance of intestinal barrier, this study has as primary objective to verify the influence of supplementation of the probiotic Lactobacillus acidophilus (LA) in the lowering of serum levels of TNF-alpha in the patients with HF.
This study characterizes heart failure patients who attended the University Hospital Würzburg. The primary aim is a better understanding of the relationships and differences between the subgroups HFrEF (EF < 40%), HFmrEF (EF 40-49%), and HFpEF (EF>50%), contributing to an improved diagnosis, prognosis and therapy of patients with heart failure.
Implanting a ventricular assist device (VAD) is a promising therapy for end-stage cardiac failure. However, the implantation of these devices is associated with a high risk of severe hemorrhages and massive blood product transfusion in the first 48 hours following the implantation. The primary purpose of this study is to assess the functionality of the von Willebrand Factor (vWF) which is essential for hemostasis. The hypothesis is that the high shear stress generated by these VAD expose ADAMTS13 cleaving site on the vWF. This result in a loss of high molecular weight vWF and an acquired von Willebrand syndrome. The secondary purpose of the protocol is to assess platelet function after the implantation of VAD. Indeed, platelet function might be affected shortly after the implantation of the device.
The objectives of the Clinical Validation Through Analytical Study With Urine Samples to Compare the Effectiveness and Security of an Intelligent Device are: 1.To evaluate the performance of S-There Device in comparison to the golden standard used in the lab.
Subsequent to the loss of myocardium post-myocardial infarction (MI), the affected ventricle undergoes some dynamic structural and functional changes known as remodeling. Cardiac remodeling progresses into heart failure (HF). In this revolutionized percutaneous coronary intervention (PCI) era, the incidence of post-MI HF due to cardiac remodeling remains high. Current standard therapeutic interventions, for HF, aimed solely at correcting a low cardiac output do not necessarily impede HF progression. Recently, doxycycline was found to have an additional biological effect aside from their antimicrobial actions. From several experimental studies and clinical trials, doxycycline showed MMP inhibition activities that can prevent ventricular remodeling. This study aims to evaluate the role of doxycycline in cardiac remodeling prevention post-MI. Our hypothesis is that a better heart function will be observed in STEMI patients who receive a short period of doxycycline administration post-PCI.
Heart failure (HF) is currently considered a common pathology, with 15 million adults in Europe and 26 million worldwide. The American Heart Association (AHA) estimates that their number will increase by 25% by 2030. In France, HF affects more than one million people. Because of the repeated hospitalizations of this disease, it is considered a costly pathology and with a high mortality rate (23.000 deaths per year in France). Moreover, HF is a severe pathology that affects the quality of life of patients and their families. Treatment and medical follow-up are required. A cardiac rehabilitation program is also a primary indication according to the latest recommendations and repositories in Cardiology. Various studies show that "Interval Training" exercise program improves VO2 peak compared to a "continuous" program, which constitutes a major prognostic factor in the population of heart failure. However, it is sometimes a difficult program to offer to more deconditioned patients as it requires reaching powers around 80% - 95% of its maximum exertion capacity. So, a variant of the interval training is offered, called Progressive Interval Training (PIT), based on the same model as the conventional interval training (CIT), but with an increasing power and breathing threshold, so that the patient can adapt gradually. The hypothesis is that PIT could improve VO2 peak better than CIT in cardiac rehabilitation program. Therefore, study the benefits of PIT training to improve the conditioning and quality of life of patients with chronic heart failure will be studied.
Metabolic abnormalities (e.g., hypertension, diabetes mellitus, dyslipidemia, and obesity) and unhealthy lifestyle behaviors (e.g., smoking and drinking habits, sedentary behavior, sleep disorder and physical inactivity) and unhealthy diet (e.g., high sugar and high fat) are major risk factors for cardiovascular diseases mobility and mortality. The investigators sought to estimate the impact of metabolic abnormalities, lifestyle behavior and diet pattern on prognosis of heart failure. This study planned to consecutively enroll 1,500 participants with heart failure with reduced ejection fraction and heart failure with mid-range ejection fraction fulfilling the inclusion criteria. Each heart failure survivors will be followed up for 5 years. Information on metabolic diseases, lifestyle and diet pattern were obtained through standardized questionnaire. The major adverse cardiac events will be identified by reviewing pertinent medical records and discharge lists from the hospitals, or official death certificates collected at local death registration centers, or directly contacting participants' family. The Cox proportional hazard model will be used to assess the association between metabolic risk factors and lifestyle and diet habits and health outcomes in heart failure patients.