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RATIONALE: Cardiac resynchronization therapy (CRT) is known to improve cardiac performance and to reduce morbidity and mortality in reduced-ejection fraction heart failure (HFrEF) despite optimal medical therapy (OMT). Several studies have shown that patients with with left bundle branch block (LBBB) respond favourably to CRT, whereas there is less certainty about non-LBBB morphology. Specifically, whether patients with right bundle branch block (RBBB) and HFrEF benefit from CRT is unclear. Some studies suggest lack of favourable outcomes. It follows from this that VVI implantable defibrillator are implanted in most RBBB patients.On the other hand right ventricular bifocal stimulation could be useful as an alternative approach in patient with RBBB. It consists of two endocardial leads implanted in right ventricle. The first lead is implanted in His bundle area, and the second lead is in the right ventricle apex. In this way bifocal pacing could decrease the inter- and intraventricular delays, thus improving left ventricular hemodynamics. However no specifically randomized studies are designed to date. PURPOSE: To demonstrate the superiority of right ventricular bifocal stimulation over placebo (VVI implantable defibrillator) in RBBB and HFrEF despite OMT. DESIGN Multicenter prospective randomized, double blind cross-over study. MASKING Investigator responsible for device programming is masked from having knowledge about clinical, functional, and echocardiographic data. On the other hand echocardiographist is masked from having knowledge about stimulation mode. Patients are masked from having knowledge about their clinical, functional, and device data. POPULATION At least fifty patients would be enrolled. The enrollment period should be one year. Study overall duration should be two years. ELIGIBILITY CRITERIA RBBB and HFrEF (left ventricular ejection fraction ≤35%) in sinus rhythm, in NYHA class II-III or ambulatory IV despite OMT. EXCLUSION CRITERIA -Refusal or withdrawal of informed consent.Renal failure (glomerular filtration rate ≤ 60 ml/min).Life expectancy < 12 months.Active neoplasm.Permanent atrial fibrillation.40 days following acute coronary syndrome.Atrio-ventricular block (from second degree AV block).Valvular heart disease with surgery indications. PROTOCOL Each patient undergoes baseline assessment. Pharmacological therapy, hospitalization,NYHA functional class, QRS complex informations, type of heart disease and comorbidities are collected. Quality of life (QOL) is defined by Minnesota Living with Heart Failure questionnaire. Functional capacity is assessed by 6MWT (optionally by cardiopulmonary exercise test). Trans-thoracic echocardiogram is performed, analyzing: left-ventricle diameters and volumes, left-ventricle ejection fraction (LVEF), left atrial diameter and area, TAPSE,valvulopathy,systolic pulmonary artery pressure. All patients undergo bifocal right ventricular resynchronization therapy: right atrial lead is implanted, whereas the first ventricular lead is placed in His bundle area, and the second ventricular lead in the right ventricle apex. Then the leads are connected to the respective channels of a CRT-D generator.After the implant, all devices are programmed in VVI mode. After the first 40±10 days (first f-up) patients are 1:1 randomized to VVI mode 40 beats/minute (placebo arm) or bifocal DDD-mode 60 beats/minute (with VV delay 0 msec and optimal AV delay). After six months (second f-up) a clinical and instrumental assessment equal to baseline is performed, as well as devices electrical parameters control. Then arms cross-over is performed (from VVI-mode to bifocal DDD-mode and vice versa). At 12 months (end of follow-up) an evaluation equal to that performed at 6 months is assessed. Echocardiographic data are unravelled to the investigator responsible for device programming. In this way the stimulation mode able to determine the best clinical improved (VVI or bifocal DDD mode) is programmed and the study closes. PRIMARY ENDPOINT The main assumption is that bifocal stimulation can increase of at least 20% the distance walked during 6MWT in respect of baseline and VVI-mode.The primary endpoint is the distance walked (expressed by meters) during 6MWT, as assessed at baseline, 6-months follow-up and 12 months follow up. Specifically changes in 6MWT observed during bifocal DDD-mode compared to baseline and to VVI mode would be significative if there is an increase of at least 20%. SECONDARY ENDPOINT Secondary endpoint is bifocal stimulation therapy response, defined by at least one of the following criteria, evaluated at baseline, 6-months follow-up and 12 months-follow-up in comparison to baseline and VVI mode: NYHA functional class improvement; changes in 6MWT, defined by an increase in distance walked major or equal to 30%; LVEF improvement major or equal to 25%;Left ventricular telesystolic volume reduction major or equal to 15%
Primary Objective: - To demonstrate that sotagliflozin reduces cardiovascular (CV) mortality and morbidity (composite of CV death or hospitalization for heart failure [HHF]) compared to placebo in hemodynamically stable patients with type 2 diabetes (T2D) and heart failure (HF) with left ventricular ejection fraction (LVEF) <50%, after admission for worsening heart failure (WHF). - To demonstrate that sotagliflozin reduces cardiovascular (CV) mortality and morbidity (composite of CV death or hospitalization for heart failure [HHF]) compared to placebo in hemodynamically stable patients with T2D and HF irrespective of LVEF after admission for WHF. Secondary Objectives: - To demonstrate that, when compared to placebo in the toal patient population, sotagliflozin reduces the total number (i.e., including recurrent events) of the following clinical events: - Cardiovascular death, HHF or urgent HF visit. - To demonstrate that, when compared to placebo, sotagliflozin reduces: - The composite of positively adjudicated sustained ≥50% decrease in eGFR, chronic dialysis, renal transplant or positively adjudicated sustained eGFR <15 mL/min/1.73 m2 in the total patient population. - Cardiovascular death in patients with LVEF < 50%. - Cardiovascular death in the total patient population. - All-cause mortality in patients with LVEF < 50%. - All cause mortality in the total patient population. - To demonstrate the safety and tolerability of sotagliflozin in the total population in this study.
The purpose of this study is to evaluate the clinical utility of comprehensive medication monitoring using the Patient Medication Profile to improve heart failure patient medication therapy and associated outcomes relative to usual care in a hospital setting.
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?
This study compares the effectiveness of two different approaches to advance care planning among older African Americans and older Whites living in the community. The two approaches are a structured approach with an advance care planning conversation led by a trained person using Respecting Choices (First Steps) and a patient-driven approach which includes a Five Wishes advance care planning form written in plain language. The study will determine which approach is more effective at increasing advance care planning within each racial group and reducing differences between the two groups in advance care planning.
This is an investigational study of experimental Medication BMS-986231 given to participants with weakened or damaged liver function.
A study of participants hospitalized with acute heart failure with reduced ejection fraction
The present study is testing in a combined design to types of drugs in patients with chronic heart failure: 1) Hydralazine in combination with isosorbide dinitrate (BiDil) and 2) Metformin hydrochloride. The study is double blind, placebo controlled. 1. The first hypothesis is that hydralazine in combination with isosorbide dinitrate can reduce mortality and hospitalization with worsening heart failure. 2. The second hypothesis is that treatment of underlying insulin resistance/ type 2 diabetes with metformin in heart failure patients with moderately to severely reduced LVEF can reduce mortality and cardiovascular hospitalizations. Among secondary endpoints are reduction in new-onset diabetes in heart failure patients with insulin resistance and diabetes risk profile and patient safety.
STRATS-AHF (STrain for Risk Assessment and Therapeutic Strategies in patients with Acute Heart Failure) registry enrolled 4,312 patients hospitalized for acute HF from 3 tertiary university hospitals (Seoul National University Bundang Hospital, Seoul National University Hospital, and Chungnam National University Hospital) from January 2009 through December 2016.
What is proposed in this project is to develop and evaluate the effectiveness of an online remote monitoring system that is easily accessible to patients so that professionals with experience in monitoring patients with heart failure (HF) can monitor signs and symptoms of decompensation of the disease, as well as self-care actions. A randomized, blind trial for outcome evaluation was designed that will include patients hospitalized for acute HF at a referral institution in cardiology in southern Brazil. Patients in the intervention group will be followed up with a remote monitoring system, accessible by device (computer, tablet and cell phone) connected to the internet, by checking for signs, symptoms and self-care actions in three moments during 30 days after hospital discharge. Patients in the control group will follow up according to the routine of the hospital or physician assistant. The primary endpoint for assessing the efficacy of the system will be hospital readmission within 30 days (follow-up period). The information regarding the signs, symptoms and self-care of the patients will be monitored by the research team through an access schedule. The sample calculation points to the need to include a total of 142 patients (71 in each group). The data will be analyzed through descriptive and analytical statistics. It is hoped that the development of a remote monitoring system could be characterized as a strategy for the early detection of signs and symptoms of acute decompensation in HF patients, impacting on hospital readmission rates within 30 days after discharge. In addition, remote monitoring of signs and symptoms may promote improved adherence and self-care of patients. The scientific contribution will occur to the extent to which there is innovation in patient follow-up and feedback obtained from the patient's interaction with the system.