mteb/BIRCO-ClinicalTrial-Test huggingface dataset:
The Gulf Heart Association (GHA) sponsored Gulf acute heart failure registry (Gulf CARE)is a multinational , multicentre, prospective, observational, hospital-based registry of patients with acute heart failure(AHF) with 3 month and one year follow-up. Study Hypothesis: Due to variations in age at presentation, risk factors for heart failure particularly high prevalence of rheumatic heart disease in certain Gulf countries, variable medical practices and heart failure management setup in the Gulf region, AHF patients in the Gulf states are expected to have different presentation and receive different management than patients in European countries resulting in different outcome. It is also hypothesized that there is considerable gap between heart failure management guidelines and clinical practices in the Gulf region. The Gulf Heart Association (GHA) initiated Gulf acute heart failure registry (Gulf CARE)is designed to assess epidemiology, clinical data, management and outcomes of AHF in six Gulf countries and whether published, professional guidelines on the diagnosis and treatment of heart failure are being applied appropriately in patients with heart failure. The registry will also provide a quantitative estimate as well as qualitative description of the hospital disease activity related to heart failure. The information gathered will identify management gaps in diagnosis and care of AHF patients that may be addressed by more effective implementation of current guidelines or development of AHF guidelines which may be appropriate to this region.
This project seeks to collect data on healthcare utilization and expenditure rates in Juvenile Idiopathic Arthritis (JIA) patients from across the US, correlate these costs with disease activity and outcome measures and determine methods by which to reduce the economic impact while improving outcomes. SPECIFIC AIMS AND OBJECTIVES The specific aims of this registry protocol are: - To create and maintain a secure online database of patients with JIA - To collect data elements related to cost of care in patients with JIA - Compare standard outcome and disease activity measures to health care expenditures in JIA - To determine methods by which to reduce costs while improving outcomes and quality of care The study plans to enroll 300 or more subjects from 3 medical centers in the US over a 24 month period. Subjects in the study are patients with Juvenile Idiopathic Arthritis. Enrollment into the protocol will include key demographic and clinical data including, medication exposures, disease severity, and function including disease-specific data elements; and estimates of health care service utilization and health care expenditures. Data will be collected once per subject within the context of a standard of care visit.
The purpose of this study is to evaluate the safety and plasma concentration change of YM150 after repeated administration to healthy elderly male and female subjects.
Background: Early physical therapy (PT) intervention with emphasis on spinal stabilization has been shown to benefit individuals undergoing lumbar spinal surgery. Further, training cervical spine stabilizers (deep cervical flexors and cervical multifidus) has been shown to be effective in reducing neck pain, restoring cervical spinal function and mobility in many types of cervical spine dysfunction. However, the training of stabilizers has not been studied in individuals undergoing cervical spinal surgery, even though these individuals often have problems with residual pain and weakness after the surgery. Purpose: The purpose of this study is to compare the effectiveness of clinical outcomes between an early PT intervention and usual care in patients who have undergone anterior cervical spine fusion (ACF) surgery. A study hypothesis is that outcomes will be improved with early PT intervention. Methods: This study is a double-blinded randomized clinical trial with a two-factor (2x3) research design. The patients following ACF surgery will be randomly assigned in one of the two treatment groups: usual care and early intervention. Three outcome measures will be collected pre-operative for baseline, and then at 6-week and 12-week post-operative follow-up visits, including: (1) deep cervical flexor (DCF) strength as determined by the cranio-cervical flexion (CCF) performance test, (2) patient's perceived disability associated neck pain as determined by the Neck Disability Index (NDI) questionnaire, and (3) neck pain level using the numeric pain rating scale (NPRS).
The purpose of this study is to test the hypothesis that a comprehensive post-discharge disease management system is more effective in reducing the readmission rate for heart failure patients compared to standard care. Heart failure, a disease that affects a large proportion of the aging population, continues to be associated with poor outcomes especially in patients who require hospitalization. Each year, nearly 1 million Americans are newly diagnosed with congestive heart failure and currently, there are at least 5 million Americans living with this chronic disease. The number of patients with heart failure is expected to reach 10 million by the year 2037.This population consumes a large proportion of health care resources with the main cost being hospitalization. The heart failure 30-day readmission rates hover around 25% nationally, with an approximate cost of $7,000 per hospitalization. In an effort to improve care and reduce costs, heart failure disease management programs are becoming more prevalent. Recent data suggests that multi-disciplinary disease management programs may reduce mortality and hospitalizations as well as improve costs, patients' ability to self-care, and quality of life. It provides a means to increase the use of evidence-based therapies, improve patient education, and decrease resource usage. Heart failure management programs involve early assessment, optimized treatment, easy access to care, and education and psychosocial support. Patients hospitalized for decompensated congestive heart failure are among the highest risk group for morbidity and mortality among people with chronic heart failure and a large proportion of this risk occurs early after discharge.
Sickle cell disease (SCD) is an inherited blood disorder that causes the red blood cells to change their shape from a round shape to a half-moon/crescent or sickled shape. Sickle-shaped cells can cause problems by getting stuck in blood vessels, blocking blood flow, and can cause inflammation and injury to important body parts. There are no specific treatments that improve this condition and promote blood flow hindered by sickle cell blockages. Another big challenge in managing sickle cell disease is that there are no good measures to determine changes and improvements in blood flow. Contrast-enhanced ultrasound is a technique currently used to detect blood flow in the heart, muscles, and other organs. It is extremely sensitive and can detect blood flow in the smallest of blood vessels. It would be very useful in helping healthcare providers know whether treatment strategies are improving blood flow during sickle cell blockages. The hypothesis is that contrast-enhanced ultrasound will be a feasible tool for determining changes in blood flow of subjects with sickle cell disease. Sickle cell disease is an inherited blood disorder that affects one of every 400 African-Americans newborns in the United States. Sickle cell disease causes the red blood cells to change their shape from a round shape to a half-moon sickle shape. Individuals who have sickle cell disease have a different type of protein that carries oxygen in the blood (hemoglobin) than individuals without sickle cell disease.
The purpose of this study is to determine whether a combined diuretic therapy (loop diuretics with thiazide-type diuretics) is more effective (in terms of improving fluid overload symptoms) among patients with decompensated heart failure in comparison with loop diuretic alone. Volume overload is an important clinical target in heart failure management, typically addressed using loop diuretics. An important and challenging subset of heart failure patients exhibit fluid overload despite significant doses of loop diuretics. One approach to overcome loop diuretic resistance is the addition of a thiazide-type diuretic to produce diuretic synergy via "sequential nephron blockade," first described more than 40 years ago. Although potentially able to induce diuresis in patients otherwise resistant to high doses of loop diuretics, this strategy has not been subjected to large-scale clinical trials to establish safety and clinical efficacy. Combination diuretic therapy using any of several thiazide-type diuretics can more than double daily urine sodium excretion to induce weight loss and edema resolution. To our knowledge there are no clinical trials designed to prove the efficacy and safety of combined diuretic therapy (a commonly used therapy) among patients with decompensated heart failure.
The aim of this randomized, double-blinded, sham-controlled cross-over trial is to demonstrate the effectiveness of continuous transcutaneous electrical stimulation of the pharyngeal dilator muscles to reduce sleep-disordered breathing. Obstructive sleep apnoea is the most common problem of sleep-disordered breathing. It affects at least four percent of the male and two percent of the female adult population. It is associated with excessive daytime sleepiness, causing significant disturbance of daytime routines affecting work, social life and memory; untreated, it also causes a significant cardiovascular and metabolic risk. The best available treatment for obstructive sleep apnoea is continuous positive airway pressure (CPAP). However, not everyone eligible tolerates this treatment because it requires them to sleep with a nasal or full-face mask that is connected by a tube to a machine. Although CPAP is recommended by the National Institute for Health and Clinical Excellence (NICE) for moderate-severe sleep apnoea, approximately one third of sleep apnoea patients who should be on CPAP stop therapy within five years. Mild sleep apnoea is currently treated with mandibular advancement splints and generic sleep hygiene advice. Continuous transcutaneous electrical stimulation (CTES) of the submental region activates the muscles that dilate the upper airway. This is where airway obstruction occurs in sleep apnoea. It has been shown that CTES at night for short periods (10minutes) effectively stimulates the genioglossus muscle, the strongest pharyngeal dilator and reduces upper airway obstruction, work of breathing and neural respiratory drive in patients with sleep apnoea.
This study examines whether a nurse monitored management program at the hospital heart failure outpatient clinic can improve quality of life in elderly patients with chronic heart failure, as compared to standard treatment in primary healthcare. Patients 60 years of age or more hospitalized with heart failure according to New York Heart Association (NYHA) class II-IV and systolic dysfunction (left ventricular ejection fraction less than 0.45) are investigated before discharge and than randomized to the nurse monitored management program or to standard care. Examinations are performed at 0, 6, 12, and 18 months, and include clinical signs and symptoms, quality of life, biochemical assessment, echocardiography and drugs used. The study will be completed when all patients have passed the 18 month follow up examination. Quality of life is assessed by the Nottingham health profile.
Approximately half of hypertensive patients have diastolic dysfunction and diastolic dysfunction is associated with development of congestive heart failure and increased mortality. Although diastolic heart failure associated with hypertension is a clinically significant problem, few clinical trials have been conducted and there is no proven pharmacological therapy to improve outcomes. To the best of the investigators knowledge, there has been no randomized trial to demonstrate that an antihypertensive drug improves diastolic function in hypertensive patients with diastolic dysfunction. The investigators hypothesize that fimasartan added to standard therapy will be superior to placebo in improving diastolic dysfunction in mildly symptomatic patients with hypertension and diastolic dysfunction, and try to examine this hypothesis in a double-blind, randomized comparison study using echocardiography. Approximately half of hypertensive patients have diastolic dysfunction and diastolic dysfunction is associated with development of congestive heart failure and increased mortality. The Framingham study reported that 51% of patients with HF have a preserved left ventricular (LV) ejection fraction and hypertension is the strongest risk factor for HF with preserved ejection fraction, also termed diastolic heart failure. The rates of death and morbidity in these patients are as high as in patients with HF and a low LV ejection fraction. Hypertensive patients are at increased risk of developing LV hypertrophy and myocardial fibrosis, which cause relaxation abnormality and decreased compliance of LV with a rise in the LV diastolic pressure. Although HF associated with hypertension is a clinically significant problem, few clinical trials have been conducted and there is no proven pharmacological therapy to improve outcomes.
The purpose of this study is to test whether a culturally sensitive self-management (SM) intervention, compared to an education only control, will reduce all-cause hospital days in patients with mild to moderate heart failure and household income less than $30,000 per year. The purpose of the CHART research study is to assess the value of a novel multi-level intervention for low-income patients recently hospitalized with heart failure relative to providing education alone (both strategies are described in detail in the Intervention section below). The investigators refer to their novel intervention strategy as 'Enhanced Training' and their education-only strategy the investigators refer to as 'Enhanced Education'. These two strategies of participant follow-up will be assessed and compared by analyzing patient's all-cause hospital days over a 2.5-year follow-up period (the investigators note that, for patients with heart failure, the average number of such all-cause hospital days over a 2.5-year period has tripled over the past 25 years). The Enhanced Training strategy aims to improve patient receipt of evidence-based therapy by: 1) activating patients using a culturally sensitive approach that might better resonate with the investigators predominantly urban, African-American and Hispanic, target population; 2) providing timely and useful information to the primary care provider; and 3) promoting effective communication between patients and their primary care provider. The Enhanced Education strategy is less intrusive and aims to provide patients and primary care providers with appropriate educational materials via mail.
This trial is a randomized study of the MitraClip device in heart failure patients with clinically significant functional mitral regurgitation. A hierarchical composite of all-cause mortality and recurrent heart failure hospitalizations is hypothesized to occur at a lower rate with the use of the MitraClip device in addition to optimal standard medical therapy compared to optimal standard of care therapy alone. This study is a clinical evaluation of the safety and effectiveness of the MitraClip System in the treatment of clinically significant functional mitral regurgitation in patients with chronic heart failure. The objective is to further study the safety and effectiveness of the MitraClip System for the treatment of clinically significant functional mitral regurgitation in New York Heart Association Functional Class III or IV chronic heart failure patients.
The purpose of this study is to evaluate the effects of Functional Magnetic stimulation (FMS) on gastrointestinal motility in patients suffering from chronic constipation due to non-neurological issues. The goal of this pilot study is to evaluate the usefulness of FMS as a noninvasive method to stimulate the GI motility in individuals with non-neurological constipation by adopting a 5-week conditioning protocol performed in a hospital outpatient setting. FMS has demonstrated the ability to generate significant rectal pressure and enhance GI transit in normal and spinal cord injury subjects. With proper abdominal muscle conditioning, FMS may improve colonic motility partly due to improved abdominal muscle tone.
The How the Elderly Live with Pain in Heart Failure (HELP-HF) study provides the opportunity to assess the complaints of pain in a cohort of HF patient admitted to Thomas Jefferson University Hospital (TJUH). Additional information on their existing co-morbid conditions, an inventory of their prescribed medications, and details regarding the type of treatment interventions (over the counter analgesia and other comfort practices) they report using will be collected. Study Events Patients admitted to TJUH with a HF diagnosis will be identified by intensive clinical research coordinator screening methods. The potential subjects will be approached in the acute care area for interview and consent to participate. At that visit, the variables of interest will be collected and the questionnaires completed. Following discharge, the subjects will be re-interviewed at follow-up clinic visits or by telephone, depending on whether the visit is to a Jefferson University Physician provider or to an outside provider or as circumstances allow. Subjects will sign an informed consent to participate in HELP-HF. A selection of assessment questionnaires (listed below) and performance measures will be completed during the index hospitalization and at a subsequent follow up clinic visits or by telephone call. Some of these assessments involve data collection from standard of care encounters or tests and will be abstracted from the medical record. The Kansas City Cardiomyopathy Questionnaire (KCCQ) The KCCQ is a valid, reliable and responsive health status measure for HF patients and serves as a clinically meaningful outcome assessment tool that is widely used in cardiovascular research, patient management, and quality of life self-assessment.12 The Brief Pain Inventory (BPI) The BPI is one of the most widely used measurement tools for assessing clinical pain.
To investigate the effect of hydralazine isosorbide dinitrate on clinical outcomes, symptoms, cardiac parameters and functional status of African patients hospitalized with AHF and left ventricular dysfunction during 24 weeks of therapy. Administration of hydralazine/nitrates will be superior to placebo administration in reducing HF readmission or death, improving dyspnoea, reducing blood pressure and brain natriuretic peptide (BNP) in African patients admitted with AHF and left ventricular dysfunction. Heart failure (HF) is a pathophysiologic condition and is a final common pathway of most forms of cardiovascular disease. Patients with HF experience poor quality of life, recurrent emergency hospitalizations and premature mortality. Recent publications highlight the multiple challenges of dealing with an increasing burden of heart disease within an urban African community. The predominance of women and novel underlying causes contrast with the demographic of HF in high income countries. More than 50% of 5328 de novo cases of heart disease captured at a tertiary clinic in Soweto presented with some form of heart failure, mainly due to poorly treated hypertension, idiopathic dilated cardiomyopathy, peripartum cardiomyopathy and HIV-related cardiomyopathy. The most prevalent form of heart disease was hypertensive heart failure (> 1100 cases). Programs have been developed in high income countries that cost-effectively prevent progressive cardiac dysfunction in high risk individuals and apply evidence-based treatments to optimize the overall management of HF. There is, however, a paucity of data describing the etiology and underlying cardiac structure and function, as well as contemporary management of HF in low to middle income countries.
The purpose of this study is to assess the efficacy and user preference of the Newport AutoSet for Her in female obstructive sleep apnea (OSA) patients. Efficacy will be evaluated by comparing the apnea and hypopnea index (AHI) and oxygen desaturation index (ODI) of the Newport AutoSet for Her algorithm to a standard algorithm. User preference will be evaluated by subjective feedback relating to comfort, ease of falling asleep, sleep disturbance and feeling of being refreshed.
The aim of this prospective, randomized and controlled trial is to evaluate the use of the ivabradine in combination to a low-dose of beta-blocker (bisoprolol) versus up-titration of beta-blocker (bisoprolol) to obtain heart rate (HR) control with reduction in RV pacing in single-chamber or dual chambers ICD recipients HF patients with moderate to severe left ventricular dysfunction (FE ≤ 40%) and an heart rate ≥ 70 bpm in sinus rhythm over a 12-months follow up. Besides the investigators want to assess if the combination of ivabradine to a low-dose of beta-blocker (bisoprolol) versus up-titration of beta-blocker (bisoprolol) may determine a lower degree of left ventricular dysfunction progression, the reduction of ventricular arrhythmias burden and ICD appropriate therapy occurrence and the improvement of quality of life in ICD heart failure patients. Background High heart rate (HR) represent per se a risk factor for cardiovascular mortality and heart failure (HF) progression, despite optimal HF therapy. Beta-blockers remain the therapy of choice in all patients with systolic HF, but they may worsen atrioventricular (AV) conduction and increase right ventricular (RV) pacing percentage. Several studies have demonstrated detrimental effects of RV pacing on cardiac function. Percent RV pacing > 40-50% is an independent predictor of death and hospitalization for HF in implantable cardioverter-defibrillator(ICD) patients, particularly in those with preexistent left ventricular dysfunction.1,2 Cumulative RV pacing > 2% and ejection fraction (EF) < 40% are independent predictors for Ventricular Tachycardia(VT)/Ventricular Fibrillation (VF) occurrence in ICD patients.3 Therefore reduction of cumulative RV pacing as far as possible should be achieved in ICD patients.
The aim of study is to investigate the impact of two different training modalities (high intensity interval training (HIIT) versus moderate intensity continuous exercise training (MICET) on cognitive performance, cerebral oxygenation, cardiac output and physical fitness in older healthy adults, patients with metabolic syndrome, coronary heart disease and heart failure. The investigators hypothesized that HIIT modality will lead to a larger improvement in physical fitness (i.e. VO2peak), cardiovascular parameters (cardiac output and stroke volume) and cognitive performance at rest and during submaximal exercise. The primary endpoint will be the improvement in cognitive performance.
The RED-HART is a randomized double-blinded placebo-controlled study of Anakinra (IL-1 blocker) in patients with recently decompensated heart failure to determine the safety and efficacy in terms of aerobic exercise capacity and ventilatory efficiency measured with a cardiopulmonary exercise test.
Purpose: To compare the hemodynamic effects of dobutamine and milrinone in hospitalized patients who are receiving Beta Blocker Participants: Patients who are admitted to the General Cardiology and Heart Failure Services at the University of North Carolina Hospitals with acute decompensated heart failure, who have maintained steady state concentrations of beta blocker therapy (carvedilol or metoprolol), and who are deemed by the health care team to require pulmonary artery catheter placement and inotropic therapy with dobutamine or milrinone by continuous infusion. Patients that are not currently receiving beta blocker therapy will be enrolled for comparative purposes; however, any patient not at steady state (on or off beta blocker therapy) will not be enrolled. Procedures: After obtaining informed consent, patients will be assigned to the appropriate sub-study group based on beta blocker use (Study A: patients on stable doses of metoprolol and Study B: patients on stable doses of carvedilol). All patients should receive dobutamine followed by milrinone as outlined in the dosing algorithm (see inotrope dosing algorithm attached, as part of the usual standard of practice). Baseline pulmonary artery catheter hemodynamic parameters will be collected prior to administration of inotrope trial of dobutamine followed by milrinone. Hemodynamic parameters will be recorded per the dosing algorithm following initiation and dose titration. Dose titration will be determined by the health care team based upon patient response or lack thereof and tolerability.
Dose escalation study of self-complementary (sc) AAVrh74.tMCK.hSGCA delivered to single leg (low dose n=2) and bilaterally (n=6) via a major lower limb artery to the whole lower limb of limb girdle muscular dystrophy type 2D (LGMD2D; alpha-sarcoglycan deficient) patients. The proposed clinical trial is a dose escalation study of self-complementary scAAVrh74.tMCK.hSGCA to LGMD2D (alpha-sarcoglycan deficient) subjects delivered via a major lower limb artery of each leg sequentially by isolated limb perfusion (ILP). Three cohorts (Cohorts 1A, 1B, and 2) will undergo gene transfer in a dose escalation scheme to establish maximum tolerated dose (MTD) using toxicity. Two (n=2) adult wheelchair-dependent patients will be enrolled in Cohort 1A and three (n =3) ambulatory subjects will be enrolled in Cohort 1B. Three (n =3) ambulatory subjects will be enrolled in Cohort 2. The first cohort (1A) will receive a dose of 1E12 vg/kg in a single limb with delivery to the whole limb. This same dose will be delivered to both limbs in Cohort 1B. Cohort 2 will receive a total dose escalation of 3E12vg/kg per limb delivered to both extremities. The vector will be infused into an indwelling catheter in the femoral artery. This will be a one-time vector infusion to an isolated limb with a 10-minute dwell time. The total vector genome dose for each subject will be adjusted by rounding down to the closest 10 kg.
This study objective is to assess the nutritional status of Patients With Congestive Heart Failure.
Clinical trial in patients with obstructive sleep apnoea that are randomised to either continue or withdraw continuous positive airway pressure therapy to identify a disease-specific exhaled breath pattern by mass spectrometry. Randomised placebo-controlled trial (therapeutic vs. subtherapeutic continuous positive airway pressure [CPAP]) including 30 OSA patients to define the effects of CPAP withdrawal (subtherapeutic CPAP) on the composition of exhaled breath analysed by mass spectrometry for identification of OSA specific markers.
To establish the performance characteristics of the Samsung LABGEO IVD-A20 CHF Test in intended use settings, by comparing test results of the A20 CHF Test with results obtained from an FDA-cleared comparator assay.
Heart failure therapies (e.g. beta blockers) have been successful in decreasing mortality rates, as well as diminishing hospitalizations. Also, pharmacist collaboration has been shown to have a beneficial impact on heart failure related outcomes. Regardless, a high residual event rate is to be noted. In our pilot study, we wished to document whether a clinical pharmacist could still play a role in the heart failure management of an elderly inpatient heart failure population.
Patients will be treated according to the clinical practice of the participating centers and to the international guidelines for the treatment of heart failure.The present analysis provides a collection of data about the changes to drug therapy after the "Cardiac Resynchronization Therapy" (CRT) procedure , and any signs and symptoms of intolerance to prescribed medications. The treatment of chronic heart failure is currently based on the use of ACE (Angiotensin Converting Enzyme) inhibitors and beta-blockers. Although this therapy is universally accepted up to 10-20% of patients may be intolerant. Moreover, the majority of patients are not treated with the doses that have been shown to be effective in controlled clinical trials. Although it is possible that even low doses of neurohumoral inhibitors are still effective than placebo, a greater benefit can be obtained at maximum doses. Therefore, it is generally recommended that these agents are used at recommended doses found to be effective in controlled studies. There are many reasons for the lack of prescription neurohumoral inhibitors and their use in non-optimal doses. These include both an inadequate clinical management, and low tolerance to drugs. As far as beta-blockers, their poor tolerability has at least two main causes: 1) the effects not related to heart failure (eg, bradycardia, AtrioVentricular (AV) block, bronchial asthma), 2) the acute negative inotropic effects, which can cause a further deterioration of hemodynamic parameters.
The purpose of this study is to evaluate the efficacy and safety of CHF 5259 (glycopyrrolate bromide) for the treatment of COPD patients. A Multinational, Multicentre, Randomised, Double Blind, Placebo-Controlled, 2-way Crossover Study to Evaluate the Efficacy and Safety of Glycopyrrolate Bromide Administered Via pMDI (CHF 5259), for the Treatment of Patients With Chronic Obstructive Pulmonary Disease
Central Sleep Apnoea (CSA) affects up to half of patients with severe heart failure and is associated with a poor prognosis. CSA is manifest as episodes of deep breathing interspersed with very shallow or absent breathing and is largely due to an exaggerated response to rising carbon dioxide in the blood, which normally drives how hard we breathe. Cardiac Resynchronization therapy (CRT), in which a pacemaker is implanted to improve co-ordinated contraction of the heart, has been shown to reduce the severity of CSA in some patient groups. We aim to determine whether this improvement is due to normalization of the body's response to carbon dioxide in the blood. Our hypothesis is that CRT improves CSA by normalizing the brain's response to carbon dioxide. Sleep disordered Breathing is common in heart failure, affecting around half of patients. This may be Obstructive Sleep Apnoea due to loss of pharyngeal muscle tone (OSA, associated with obesity and snoring and predisposing to hypertension, heart attack and stroke) or Central Sleep Apnoea (CSA). CSA is particularly prevalent in severe heart failure and associated with an adverse prognosis. The mechanism involves reflex hyperventilation due to pulmonary oedema, exaggerated chemosensor response to hypercapnoea associated with increased sympathetic nervous system activation and a prolonged circulation time. It is known that CRT improved CSA in 'responders' but the mechanism is unknown.
Domperidone is a drug that may be of benefit to individuals with gastroesophageal reflux disease (GERD), with upper GI symptoms, gastroparesis, and chronic constipation. This is a long-term treatment program for prescription of this drug to all patients who, in the investigators' judgement, could benefit from its use. The Treatment Use of Domperidone program is also available at the Cleveland Clinic Florida/Weston Gastroenterology Department. This is not a "traditional" research study, but an expanded use protocol for patients who may benefit from the drug. As such, all expenses associated with the drug, initiation and follow up of treatment are the responsiblity of the patient or the patient's third party payor.
Objective: The Ultrasonic Cardiac Output Monitor (USCOM) is a non-invasive, quantitative method for measuring and monitoring cardiovascular haemodynamic parameters in patients. The aims of this study are: 1. To investigate whether USCOM-derived haemodynamic parameters such as Cardiac output (CO), inotropy and oxygen delivery (DO2) have a role in the diagnosis of patients with a compensated heart failure syndrome (cHFS) or acute decompensated heart failure syndrome (adHFS) 2. To investigate whether USCOM-derived haemodynamic parameters such as CO, inotropy and DO2 correlate with heart failure staging, especially New York Heart Association (NYHA) class and American Heart Association (AHA) stage. 3. To investigate whether USCOM-derived haemodynamic parameters such as velocity time interval (vti), stroke volume (SV), CO, SV index (SVI), CO index (CI), inotropy and DO2 correlate with ejection fraction. 4. To investigate whether USCOM-derived haemodynamic variables may be used as prognostic indicators of 30-day, 6-month and 1-year Major Adverse Cardiac Events (MACE). 5. To evaluate the agreement between hemodynamic measurements obtained using the Ultrasonic Cardiac Output Monitor (USCOM®; USCOM Ltd., Sydney, Australia), and reference standards as determined by 2 Dimensional echocardiography (2D-echo) measurements in groups of haemodynamically stable and unstable adult patients. Design: This prospective observational cohort study will be conducted in the Prince of Wales Hospital in Hong Kong.
The response to therapy with a fixed dose combination of isosorbide dinitrate and hydralazine (FDC I/H) is enhanced in African Americans with heart failure and reduced ejection fraction (HFrEF) when compared to similar white cohorts. This study will seek to confirm the previous genetic sub-study from AHeFT which suggested a functional polymorphism of guanine nucleotide binding protein beta polypeptide 3 subunit (GNB3), C825T in exon 10, influences the therapeutic efficacy of FDC I/H. This study will initiate treatment with FDC I/H in 500 self designated African American subjects with systolic heart failure. They will be followed for up to two years on therapy. Clinical outcomes (survival, heart failure hospitalizations, and change in quality of life) on FDC I/H will be compared by GNB3 genotype subset. The hypothesis to be confirmed is that subjects homozygous for the T allele (those with the GNB3 TT genotype which is present in approximately 50% of black subjects) demonstrate enhanced therapeutic benefit from FDC I/H. The response to therapy with a fixed dose combination of isosorbide dinitrate and hydralazine (FDC I/H) is enhanced in African Americans with heart failure and reduced ejection fraction (HFrEF) when compared to similar white cohorts. Despite the clear survival benefits of treatment with FDC I/H in the African American Heart Failure Trial (AHeFT), the drug is prescribed in only 25% of black subjects who would potentially benefit.
The purpose of this study is to investigate the patient characteristics, selection of treatment, and factors associated with clinical outcomes in Japanese patients with acutely decompensated congestive heart failure. Congestive heart failure (CHF) has been markedly increasing in Japan due to the rapid aging of the society and the Westernization of lifestyle that facilitates the development of coronary artery disease. The prognosis of patients with CHF still remains poor, despite the recent advances in medical and surgical treatment. Elderly heart failure patients with preserved ejection and multiple comorbidity may account for significant portion among CHF patients in the real world clinical practice, however; most of previous prospective cohort studies excluded these patients. The KCHF registry, an all-comer, prospective, multicenter registry, was designed to investigate all patients who admitted to the hospital due to acutly decompensated CHF. The aim of this study was to clarify the patients characteristics , selection of treatment, and prognosis of patients with acutly decompensated CHF in the real-world clinical practice in Japan.
The proposed project is a 2x2 factorial designed study aimed at assessing the impact of 1) a home tele-monitoring system and 2) a flexible diuretic regimen among high risk heart failure patients in the University of Michigan Health System (UMHS). The proposed project is a 2x2 factorial designed study aimed at assessing the impact of 1) a home tele-monitoring system and 2) a flexible diuretic regimen among high risk heart failure patients in the University of Michigan Health System (UMHS). The first intervention consists of the use of a home monitoring tool utilizing a tablet interface. The device facilitates collection of heart failure patient self-care information, including weight, blood pressure, heart rate and heart failure symptoms. This information is collected and stored on a secured server provided by the vendor, and can be viewed by the physician and nursing team. The second intervention is a flexible diuretic regimen strategy. This intervention will be applied in an independent randomized fashion. The flexible regimen will be prescribed by the patient's physician. The two interventions will be applied to heart failure patients treated at the University of Michigan. A total of 400 patients will be enrolled into the study.
The purpose of this study is to evaluate existing biomarkers and see if they can be used to accurately diagnose the etiology of heart failure. This is a cohort study consisting of 2 patient cohorts. The first cohort will be studied retrospectively, using existing blood samples from different biobanks. Biomarkers will be measured and matched with the etiology of previously diagnosed heart failure by a biomarker panel of heart failure experts. This cohort consists of 100 patients each with (1) ischemic cardiomyopathy, (2) dilated cardiomyopathy and (3) diastolic heart failure. Blood samples will be analyzed for novel biomarkers. Investigators will be seeking biomarker candidate(s) alone or in combination which can predict each category of heart failure etiology with over 85% accuracy and the lowest levels of reclassification. A panel of heart failure experts will be assembled, and the appropriate cut-off values determined. Once this goal has been achieved, the prospective study will go ahead. In the second cohort, biomarkers will be measured and used to diagnose the etiology of heart failure for each subject. This diagnosis will then be compared to the diagnosis from results of the usual diagnostic tests. Investigators will recruit 450 patients admitted to hospital or outpatient clinics with recently diagnosed heart failure (<2 years) and test for different biomarkers. Using the biomarker values, investigators will predict their heart failure etiology in an objective manner.
This study will evaluate the differences in cardiovascular parameters between women with severe preterm preeclampsia and those without preeclampsia using echocardiography and maternal blood. The investigators will also look at associations of abnormal cardiovascular findings and immediate complications among a high risk cohort of pregnant African American women. This will be a prospective cohort study. Exposed cases will be admitted to the inpatient obstetrical unit (labor & delivery or antepartum unit) at the Hospital of the University of Pennsylvania with concern for severe preterm preeclampsia. Unexposed controls will be matched by gestational age and other clinical factors and will be obtained from the outpatient setting (Helen O Dickens clinic or Penn ObGyn Associates at 3701 Market Street). The investigators will compare cardiovascular risk factors between these two groups.
The overall purpose of this project is to determine the feasibility of conducting a large scale randomized clinical trial that compares remote monitoring of adherence to loop diuretics using a wireless electronic pillcap with usual care among recently hospitalized heart failure patients. The long-term goal of this program of research is to determine the effect of the adherence telemonitoring intervention on medication adherence and hospital readmissions among recently hospitalized heart failure patients. Approximately one in four patients hospitalized with heart failure is readmitted within 30 days of discharge and more than 50% are readmitted within 6 months of discharge. Heart failure admissions are a major contributor to the enormous health care costs associated with heart failure. Thus far, the identification of effective interventions that prevent unnecessary readmissions has remained elusive. As a result, there is a pressing need to identify novel, cost-effective approaches to reducing heart failure readmissions. A growing body of research suggests that poor adherence to heart failure medications is a major reason for preventable heart failure readmissions. In particular, loop diuretic medications are essential to preventing the cardiopulmonary system from becoming overloaded. Patients who have been recently hospitalized may be especially vulnerable to adherence problems as a result of the stress of the recent hospitalization which commonly induces sleep deprivation, nutritional deficiency, physical deconditioning, cognitive impairment, and even delirium. Recent advances in wireless health now enable us to remotely, unobtrusively, and objectively monitor adherence to heart failure medications in the post-discharge period.
Novartis has set up this global Multiple Patient Program (MPP) treatment plan to provide access to treatment with LCZ696 for patients that were not previously exposed to LCZ696 but have no other option to receive LCZ696 in their country prior to market authorization OR commercial availability, based on local regulatory and legal requirements.
Prospective, open-label, randomized cohort study comparing adding high-dose spironolactone to usual heart failure care versus usual care in patients with acute decompensated heart failure. Patients will be randomized in a 1:1 fashion to either usual care or high-dose spironolactone plus usual care. Both arms of the study will continue with treatment of ADHF until euvolemia as defined as the resolution of pulmonary edema, peripheral edema, abdominal bloating and/or jugular venous distention. Assessment of clinical status and serum electrolytes, symptoms and renal function will be performed in accordance to standard of care. Congestive heart failure (CHF) is common and currently affects an estimated 6.6 million adults in the United States (1). In addition being highly prevalent, CHF is responsible for ~ 1 million hospital discharges per year and approximately 50% of patients with CHF will die within 5 years making it a highly morbid and lethal disease (1). Manifestations of CHF include symptoms of volume overload such as dyspnea, abdominal bloating and/or fatigue. The genesis of these symptoms begins with loss of the integrity of arterial circulation due to decreased cardiac output (2). Decreased activation of mechanoreceptors in the carotid sinus, left ventricle, aortic arch and renal afferent arterioles due to lower systemic arterial pressure stimulates the sympathetic nervous system (SNS), renal-angiotensin-aldosterone system (RAAS) and non-osmotic release of arginine vasopressin (3).
This study evaluates the use of the STOPBANG questionnaire to predict whether an obese pregnant woman has obstructive sleep apnoea. All participants will have a STOPBANG score calculated and then be tested with overnight oximetry to see if they have obstructive sleep apnoea. Obstructive sleep apnoea (OSA) is a condition in which the muscles and soft tissues of the throat collapse during sleep, resulting in them stopping breathing for a short period. It affects around 4% of all pregnant women and is more common in obese people. Pregnant women with untreated OSA are more likely to have pregnancy complications and are more likely to need a caesarean section. Babies born to mothers with untreated OSA are more likely to need neonatal treatment. If OSA is diagnosed and treated then these risks are reduced. In non-pregnant patients presenting for surgery, an screening tool called STOPBANG has been proven to be effective in identifying patients with OSA. S: Do you Snore loudly? T: Do you often feel tired during daytime? O: Has anyone observed you stop breathing during your sleep? P: Do you have high blood pressure? B: Is your BMI >35 kg/m2? A: Are you >50 years old? N: Is your neck circumference >40cm? G: Is your gender male? The investigators aim to assess whether STOPBANG can be used to identify OSA in obese pregnant women.
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, ARA II and ARM 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.
Broad Objectives: To determine the comparative efficacy of commonly employed strategies to overcome loop diuretic resistance when added to concomitant loop diuretics in hospitalized decompensated heart failure patients with hypervolemia Specific Aims: 1. Compare the 48-hour weight change of either intravenous chlorothiazide or oral tolvaptan compared to standard-of-care oral metolazone when combined with standardized loop diuretic dosing for diuretic resistance in decompensated heart failure 2. Compare the adverse effects of electrolyte depletion and renal function changes between intravenous chlorothiazide or oral tolvaptan compared to standard-of-care oral metolazone when combined with standardized loop diuretic dosing for diuretic resistance in acute heart failure 3. Pharmacoeconomic analysis of the direct costs of intravenous chlorothiazide or oral tolvaptan compared to standard-of-care oral metolazone when combined with standardized loop diuretic dosing for diuretic resistance in acute heart failure The investigators will conduct a dual center, randomized, double-blind, double-dummy, parallel design trial comparing: oral metolazone, intravenous chlorothiazide, or oral tolvaptan, in combination with loop diuretics in 60 patients hospitalized for hypervolemic decompensated heart failure and displaying loop diuretic resistance. Background: The investigators aim to evaluate the optimal regimen for restoring diuretic efficacy in patients with decompensated heart failure demonstrating loop diuretic resistance, for which guideline-based recommendations are weak secondary to a lack of evidence. By comparing the efficacy, cost, and adverse effects of currently recommended therapies and testing a novel diuretic combination, the investigators will augment the dearth of data that exists regarding this clinical challenge.
This research trial studies whole exome sequencing in finding causative variants in germline deoxyribonucleic acid (DNA) samples from patients with congestive heart failure receiving therapy for breast cancer. Studying samples of germline DNA in the laboratory from patients with congestive heart failure receiving therapy for breast cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to congestive heart failure. PRIMARY OBJECTIVES: I. To identify, using next generation sequencing, rare variants of large effect size that impact the risk of congestive heart failure (CHF) in patients from the clinical trial ECOG-5103 (E5103). OUTLINE: Previously collected germline DNA samples are analyzed via whole exome sequencing.