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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 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).
Prospective validation of the ultrasound-assessed internal jugular vein distensibility (JVD) ratio to identify patients with systolic chronic heart failure and right atrial pressure (RAP) of 7 or less mmHg measured by the right heart catheterization. In a calibration cohort, a threshold ratio will be identified, above which the RAP is normal with the highest accuracy. This diagnostic tool with a defined threshold of the JVD ratio will be assessed in a second prospective validation cohort.
The pathophysiology of heart failure with preserved ejection fraction (HFpEF) is complex and multifactorial. Chronotropic incompetence has emerged as a crucial mechanism, particularly in elderly patients. Betablockers, drugs with negative chronotropic effect, are commonly used in HFpEF, despite current evidence does not support its routine use in these patients. The aim of this work is to evaluate the effect of betablockers withdrawal in patients with HFpEF and chronotropic incompetence on functional capacity assessed by the peak oxygen consumption at maximal exercise (peakVO2) at 15 and 30 days after the intervention
There are 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, the team 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. 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).
The study tested the usefulness of cardiopulmonary exercise test (CPET) in selection of potential responders to CRT.
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.
1. Evaluate efficacy and safety of continuous infusion of IV Frusemide compared to IV shots in acute decompensated heart failure ADHF 2. Evaluate superiority of time-adjusted metolazone to morning frusemide IV shots compared to irrespective administration (at random times) to overcome diuretic resistance
Safety and Efficacy of Cardiac Shockwave Therapy (CAST) in patients undergoing coronary artery bypass grafting