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International, Multicentre, Parallel-group, Randomised, Double-blind, Placebo-controlled, Phase III Study Evaluating the effect of Dapagliflozin on Exercise Capacity in Heart Failure Patients with Reduced Ejection Fraction (HFrEF)
International, Multicentre, Parallel-group, Randomised, Double-blind, Placebo-controlled, Phase III Study Evaluating the effect of Dapagliflozin on Exercise Capacity in Heart Failure Patients with Preserved Ejection Fraction (HFpEF)
The purpose of this study is to examine small vessel disease (a condition in which the small arteries in the heart become narrowed). The investigators want to know how the small vessel disease contributes to pre-HFpEF (a condition with inadequate heart muscle function in the setting of preserved muscle pumping) and to better identify potential treatment for prevention of HFpEF. The main procedures of this study include up to 2 clinic visits (initial visit and a second clinical visit only if participants are unable to complete all research procedures at the initial visit); a 6-week phone interview visit, 4 quarterly follow-up phone interview visits in year 1; year 1 follow up cardiac MRI based on availability and ongoing annual follow-up phone interview visits to track progress. If participants choose to take part in this study, participants direct participation will end after 1 year, participants will then have the option of participating in ongoing annual check-in calls. Participants will be asked to undergo a physical exam and provide a completed medical history; complete a Cardiovascular (or Cardiac) Magnetic Resonance Imaging (CMRI) with contrast agent; complete questionnaires to describe heart symptoms and overall quality of life status; undergo blood draws to provide blood samples for research testing, and allow the study team to have access to medical records.
This is a multicenter, randomized, double-blind, placebo-controlled, dose-response trial in patients with chronic stable Heart Failure (HF) and reduced Left Ventricular Ejection Fraction (LVEF) to evaluate the efficacy and safety of three INL1 doses compared with placebo. Patients will be treated for approximately 12 weeks with one of three INL1 doses: 50 mg, 150 mg, 300 mg, or, placebo capsules, taken twice daily (BID).
We currently have few studies on myocardial iron deficiency. In 2016, a study in Spain evaluated patients with heart failure (with or without anemia) and their response to intravenous iron infusion. These patients, initially with mean T2* values of 39.5 msec, were followed by Cardiac Magnetic Ressonance (CMR) before and after iron replacement with Ferric Carboxymaltose (Ferinject®) , obtaining at the end of the study, improvement in ventricular function and increase in the myocardial iron load (T2 * mean of 32 msec ). The aim of the present study was to evaluate the correlation between intravenous iron replacement and increased myocardial iron deposits and their effect on ventricular function. Because it is a pilot study with few data in the literature and based on the study that used a sample of 8 patients, it is planned to use an initial sample of 20 patients. In the CMR, we intent to evaluate the global ventricular function, the iron load by the T2 * method, the cardiac strain, the "Fiddle" and the "Fat water" of each patient will be analyzed. After this examination, patients will undergo intravenous 1g of Ferric Carboxymaltose (Ferinject®). A comparative analysis of the ejection fraction values at the beginning and at the end of the study by CMR will be performed, in addition to a clinical reassessment, in which improvement of dyspnea and tiredness are expected. There will be laboratory reassessment of ferritin and transferrin saturation to monitor treatment. The inclusion criteria will be: Patients older than 18 years, with iron deficiency and reduced ejection fraction defined as: serum ferritin <100 μg / L or with ferritin 100-299 μg / L with transferrin saturation <20 %; Hemoglobin <12g / dL in women and <13g / dL in men; Clinical stability in the last 3 months; Left ventricular ejection fraction (LVEF) <40% assessed by transthoracic echocardiography or CMR in the last 3 months. The exclusion criteria will be: Patients younger than 18 years, Patients with preserved ejection fraction (> 50%), pregnant women, refusal to participate in the present study, implantable pacemaker or implantable defibrillator incompatible with MRI, cerebral cerebral aneurysm clip and/or intracerebral or intraocular metal fragments, electronic cochlear implants, patients with claustrophobia, patients with clinical or hemodynamic instability and patients with indication for blood transfusion (Hb ≤ 7g / dL).
This is a prospective, single arm, early feasibility study (EFS) designed to evaluate the safety and device performance of The RenalGuard System in the management of patients admitted with signs and symptoms of congestive heart failure who require diuresis for the treatment of volume overload.
Heart failure is a complex and heterogenous disease with mortality and morbidity that equals more cancers. Numerous studies have examined the ability to improve prognostication from heart failure, ranging from basic statistical methodologies to machine learning, with impressive improvements in both predictive indices. However, no study to date has examined, in a randomized fashion, the impact of providing prognostic information on provider behavior and downstream clinical outcomes. It is for this reason that the investigators plan to perform the Risk EValuation And Its Impact on ClinicAL Decision Making and Outcomes in Heart Failure (REVeAL-HF) Trial within the Yale New Haven Health System. REVeAL-HF is a randomized, single-blind intervention trial that is testing the clinical impact of providing prognostic information to the provider on heart failure outcomes in the inpatient settings. The study hypothesis is that electronic alerting about prognostic information on heart failure patients along with links to guidelines will lead to reductions in all-cause mortality and 30-day HF hospitalizations via improved use of guideline directed medical therapy and more adequate decongestion.
This study recruited patients diagnosed with heart failure by cardiologists and cardiac outpatients whose cardiac functions were graded from 1 to 4 according to the New York Heart Association as the study participants. The participants were provided active nutrition intervention including diet optimization,specific recommendations and nutritional supplement prescriptions in cases in which nutritional goals were not reached.In addition, this study offered advice by referencing lifestyle change advice provided by the American Heart Association for patients with heart failure. The Mini Nutritional Assessment Short-Form was used to assess malnutrition indicator values. The participant water, nutrient (i.e., carbohydrates, protein, and fat), and calorie intake data were collected using their recollection of their dietary intake and food intake frequency over a 24-hour dietary recall. The amount of fluid and sodium administered was provided according to the cardiac function grades indicated by the New York Heart Association.In addition, dietary assessments and nutritional advice were offered on the basis of the patients' conditions (i.e., age, activity, and comorbidity). Finally, instrumental activities of daily living, EQ-5D (an instrument for measuring quality of life), grip performance, and 6-minute walk test data were utilized to analyze the changes in the participants before and after intervention, identifying the correlation between using nutrition education as an intervention measure and improvement in the participants' nutritional status, quality of life, and self-care behavior.
A prospective, multi-center, dual-arm randomized controlled study comparing treatment of ischemic cardiomyopathy induced heart failure with the Revivent TC System plus Guideline Directed Medical Therapy (GDMT) compared to GDMT alone.
The recent study using IRSplus and VpS algorithm from Biotronik pacemaker showed the significant reduction in ventricular pacing to less than 3%. The purpose of this study is to evaluate the efficacy of IRSplus and VpS algorithm in reducing ventricular pacing compared with conventional DDD pacing with a fixed AV delay.