View clinical trials related to Heart Failure.
Filter by:The purpose of the study is to determine the relationship between non-invasive measurement of left ventricular diastolic pressure (LVDP) using the Vivio System, compared with invasively measured LVDP via direct measurement during left heart catheterization.
This study evaluated changes in healthcare resource utilization (HCRU) and costs of care within 12 months following initiation of sacubitril/valsartan (sac/val) in commercially insured and Medicare Advantage (MA) lives in the U.S among adult patients with heart failure with reduced ejection fraction (HFrEF) (cohort 1) and adult patients with chronic heart failure (CHF) (cohort 2).
Researchers are looking for a better way to treat people with heart failure. Heart failure is a condition which occurs when the heart does not pump blood as well as it should leading to shortness of breath, tiredness, and ankle swelling. The study treatment BAY1753011 is under development to treat heart failure. It is thought to reduce the action of a hormone called vasopressin that is naturally produced in the body. People with heart failure often have elevated levels of vasopressin. This is known to result in worsening of the heart failure condition. People with heart failure often also have reduced kidney functions. As kidneys play a role in removal of drugs from the body, reduced kidney function may result in higher blood levels of BAY1753011. The main purpose of this study was to learn how BAY1753011 moved into, through and out of the body in participants with different degrees of reduced kidney function compared to matched participants (age, gender, and weight) with normal kidney function. To answer this, the researchers compared: - the (average) total level of BAY1753011 in the blood (also called AUC) - the (average) highest level of BAY1753011 in the blood (also called Cmax) between the different groups with reduced kidney function (mild/moderate/severe) and the control group (normal kidney function). In addition, the researchers wanted to know how safe BAY1753011 was and the degree to which overt medical problems caused by it could be tolerated (also called tolerability) by the different groups of participants. These medical problems are also known as "adverse events". Doctors keep track of all medical problems that happen in studies, even if they do not think they might be related to the study treatments. All participants took a single dose of BAY1753011 in tablet form by mouth. Each participant was in the study for approximately 3 to 4 weeks, including an in-house phase of 5 days and 4 nights with one treatment day. During the study, the doctors and their study team: - did physical examinations - checked vital signs such as blood pressure, heart rate, body temperature and number of breaths within a minute (respiratory rate) - examined heart health using electrocardiogram (ECG) - took blood and urine samples - counted the number of toilet visits during the night
Introduction: Heart failure (HF) is characterized by an increasing prevalence and burden, representing a public health problem and a major cause of morbidity and mortality. Self-care is a cornerstone approach for optimizing therapy for patients with HF; patients play a key role in the management of their condition, given that several negative health outcomes might be avoided with effective self-care. Motivational interviewing (MI) has been described by the literature as highly favorable for treating chronic diseases, with promising results supporting its efficacy in enhancing self-care. Moreover, caregivers' availability constitutes a fundamental supporting factor among the strategies to improve self-care behaviors in people with HF. Methods and analysis: This study protocol designed a prospective, parallel-arm, open-label, three-arm, controlled trial for purposing the aims to test the efficacy of a structured program including scheduled MI interventions in improving self-care behaviors among patients with HF at 3, 6, 9, and 12 months from the enrolment. Secondary aims comprehend the corroboration of the superiority of caregivers' participation to the structured program including scheduled MI interventions over the program administrated only to individual patients in enhancing self-care behaviors and other outcomes. Analyses will be performed within the framework of intention-to-treat (ITT). Comparisons between groups will be based on an alpha = 5% and two-tailed null hypotheses. In the case of missingness, analyzing the extent of the missingness and identifying underlying mechanisms and patterns will guide imputation methods. Ethics and dissemination: The study protocol and template consent forms have been reviewed and approved by the Ethical Committee of San Raffaele Hospital (approval #74/INT). Also, the study protocol has been registered at ClinicalTrials.gov (Identifier: …….). Patients and caregivers will have to sign the informed consent forms before the randomisation. Patients and caregivers may leave the study at any time. The withdrawal from the study will not imply any prejudice, as fully documented and explained in the informed consent. Considering the open-access publication, the full protocol will be available freely.
SUMMARY Rationale Patients with heart failure may suffer from a poor quality of life (QoL) due to frequent hospital admittance, medication intake, and symptoms as a result of progression of their disease. The general salt intake in the Dutch population is too high, leading indirectly to hypertension resulting in worsening of cardiovascular disease such as heart failure. Patients with heart failure are highly salt sensitive. A quarter of the daily salt intake originates from bread. Salt restriction is difficult to maintain. The aim of this study is to lower the daily salt intake by providing a palatable low salt bread to patients with heart failure. This may lead to a stable disease and therefore an improvement in quality of life. Objective The aim of this study is to investigate whether substitution of normal bread by a new palatable form of low salt bread is effective in reducing salt intake in patients with chronic heart failure. The investigators will evaluate the effectiveness, the compliance and the outcome of the presumed salt reduction. Study design This is a single center, randomized, double blinded, cross-over trial with a follow-up period of twelve weeks performed in VieCuri, Medical Centre in Venlo. Study population In this study, 20 patients visiting the outpatient clinic with heart failure NYHA class 3-4 will be included. All patients are 18 years or older. Intervention Given the study design all 20 patients receive a low salt bread (0.05 gram sodium per slice) for one period and received bread with a normal amount of sodium (0.35 gram sodium per slice) in the other period. After six weeks follow up, the groups change the intervention. Main study parameters/endpoints The investigators expect a reduction of daily salt intake of 1.5 gram sodium by an average of 5 slices bread a day. Nature and extent of the burden and risks associated with participation, benefit and group relatedness Patients should visit the hospital three times. Prior the hospital visit they have to collect 24- hour urine. During all visits blood samples will be taken and a physical exam is performed. Also blood pressure will be measured. Most of these parameters are also collected for clinical purposes. Patients should at the same time report their daily intake in a personal food diary and fill in questionnaires about their opinion of the bread and quality of life.
The study includes two parts: Part 1: - 100 examinations of patient referred for echo evaluation, containing clips that were acquired from the 4CH apical view were collected retrospectively. Each study includes 10 clips that represent typical user scanning errors - Offline evaluation of the system (by batch processing) shall be performed by comparing the system output to preliminary quality tagging by experienced sonographers Part 2: - Live scans of apical 4CH clips of patients with indication for POCUS examination will be performed by POC physicians - LVivo IQS shall be used (on Lumify) during the scan for patients that meet inclusion criteria until 50 exams will be collected. 3 sec of each scan shall be saved, and Image quality score (IQS) shall be documented - Saved scans shall be reviewed by an expert physician to determine whether they are clinically interpretable
Chronic heart failure (CHF) is a global pandemic which affects around 26 million people worldwide and develops in 10% of people over 70 years . According to the results of the EPOCHA-CHF study, CHF is detected in 7-10% of cases in the Russian Federation . Atrial fibrillation (AF) is the most common arrhythmia in patients with both preserved (HFpEF) and reduced ejection fraction (HFrEF) heart failure. The prognostic impact of AF on CHF is negative, including the significant increase in mortality and hospitalization. One of the common causes of decompensation of CHF is AF. The debut of AF in CHF is one of the markers of disease progression. Rapid development in interventional cardiology due to the invention of cardiac catheter technologies during the last decades provided a new option for non-pharmacological treatment of CHF. Nowadays the use of electrophysiological methods of treatment can significantly improve the prognosis of CHF. Pacemakers, cardiac resynchronization devices, and cardioverter defibrillators are the most commonly implanted devices in patients with CHF. In 2014, the European Society of Cardiology presented a report of the European Heart Rhythm Association on the use of new devices for CHF, including the Optimizer device for delivery of cardiac contractility modulation therapy (CCM) . It is worth noting that CCM is a new step in the CHF treatment. This device is of proven benefit to patients with symptomatic heart failure on optimal medical therapy who do not qualify for cardiac resynchronization therapy. Multiple studies of CCM show clinical improvement with this therapy, including metrics such as peak VO2, 6MW, and NYHA functional class. However, the vast majority of patients enrolled in these studies were patients in sinus rhythm. As the technology progressed and the need for the trial sensing led wanted, further experiences incorporated patients with AF. A new generation of devices (Optimizer Smart®), which does not require the implantation of an atrial electrode made it possible to implant CCM in patients with AF. The present trial demonstrates the results of a pilot study conducted in National Medical Research Center of Cardiology Ministry of Health of the Russian Federation which compares the efficacy of CCM in patients with AF and ischemic and non-ischemic CHF compared to patients who received only optimal drug therapy CHF
Patients with heart failure (HF) have poor prognosis with high mortality and readmission rates. Diuretic therapy is the usual way of managing congestion, but sometimes is difficult to determine when we have reached euvolemia. Even in overweight and obese patients in which physical examination and usual diagnostic techniques have strong limitations. The aim of this study is to investigate the usefulness of bioelectrical impedance analysis (BIA) in management and treatment of HF in overweight and obese patients. The study included overweight and obese patients who were admitted with acute decompensated HF. The study population was randomized into two arms: BIA-guided therapy or standard care. Serum electrolytes, kidney functions and natriuretic peptides were followed up during their hospital stay and at 90 days after discharge. The primary endpoint was development of acute kidney injury (AKI) stage III (AKIN-III) during hospitalization and the main secondary endpoint was the reduction of NT-proBNP (N-terminal pro-B-type natriuretic peptide) levels during hospitalization and within 90 days after discharge.
Thirty years ago, Dzau and Braunwald introduced the concept of a continuum of cardiovascular diseases and defined them as a series of events caused by numerous related and unrelated risk factors, thus developing to end-stage heart disease through many pathophysiological pathways and processes. Owing to treatment concept changes and the urgency of investigating T2D combined with CHF, SUs are being re-evaluated, of which glimepiride is undoubtedly the most promising.
Malnutrition is common in patients with heart failure (HF) and is associated with a worse prognosis. However, there is little information on the impact of nutritional intervention in malnourished patients with heart failure. Therefore, the aim of our study is to evaluate whether a specific nutritional intervention has an impact on mortality and hospitalizations, quality of life, nutritional status, and functional capacity in patient with heart failure and malnutrition.