The Effect of Obesity and Weight Loss in Heart Failure With Preserved Ejection Fraction
Heart Failure With Preserved Ejection FractionObesityThis study looks at the effects of weight loss in people who have heart failure with preserved ejection fraction (HFpEF) and are overweight or obese. The main questions it aims to answer are whether weight loss in this group of people improves: The heart's shape, how well it pumps blood and how well it uses fuels The person's quality of life and how much they can exercise Participants will attend 2 study visits, separated by 3-6 months. The intervention period takes place in between the 2 study visits. Each study visit will involve measurements including: Symptom and quality of life questionnaires Body measurements such as height and weight Blood tests Ultrasound scans of the heart (echocardiogram) Magnetic Resonance Imaging (MRI) scans of the heart Exercise components during the scans 6 minute walk test Participants are randomly allocated (in other words, by lottery) to either 'diet' or 'control' groups. The control group will continue standard care. The diet group will be enrolled in a weight loss program supervised by the study team. Participants in the diet group will replace their usual meals with meal replacement products specifically designed to deliver a low calorie diet for weight loss. The products will consist of formula soups, shakes and porridges. This diet would last 8 weeks, followed by a guided period of food reintroduction and maintenance.
CAtheter-Based Ablation of Atrial Fibrillation Compared to Conventional Treatment in Patients With...
Atrial FibrillationHeart Failure With Preserved Ejection Fraction1 moreThe objective of CABA-HFPEF is to test whether catheter ablation (CA) for atrial fibrillation (AF) can prevent adverse cardiovascular outcomes in patients with heart failure with preserved (HFpEF) or mildly reduced ejection fraction (HFmrEF).
Furoscix in Heart Failure Patients With Diuretic Resistance
Heart FailureThis will be a randomized, open-label pilot study of 60 patients with and without diuretic resistance who were recently admitted and discharged for acute decompensated heart failure with and oral diuretic regimen testing whether Furoscix is more effective at achieving post-discharge outpatient diuresis than standard of care. Diuretic resistance will be identified using the BAN-ADHF (BUN, creAtinine, NP-levels, Age, Diabetes and DBP, HF hospitalization, and atrial Fibrillation) score which has been integrated into the electronic health record. The score is integer-based with a score of > 11 indicating diuretic resistance with high likelihood of poor outcomes. The primary outcome is diuretic efficacy as measured by volume of urine produced 8 hours after treatment and urine sodium levels (assessed hourly or per urination episode within 8 hours of treatment).
The Hemodynamic Effects of SGLT2i in Acute Decompensated Heart Failure
Acute Decompensated Heart FailureThe main purpose of this study is to observe hemodynamic effects of initiating sodium-glucose co-transporter 2 inhibitors (SGLT2i) in patients admitted to the intensive care unit (ICU) with acute decompensated heart failure.
Left Bundle Branch Area Pacing for Cardiac Resynchronization Therapy: A Randomized Study
Heart Failure With Reduced Ejection FractionThe aim of this study proposal is to compare the effectiveness of two distinct pacing modalities for cardiac resynchronization therapy. Our primary hypothesis is that left bundle branch area pacing (LBBAP) using conventional stylet driven pacemaker leads is an effective resynchronization method that yield to at least similar clinical benefits and outcomes when compare to biventricular pacing.
A Feasibility Non-inferiority Clinical Trial for Dosing of Diuretics in CHF Patients
Congestive Heart FailurePatients with heart failure are frequently hospitalized, have a reduced quality of life and face a higher risk of death. Much of the morbidity and reduced quality of life associated with CHF is related to symptoms of volume overload. Loop diuretics are a mainstay in the management of volume overload and edema in CHF. Diuretic resistance is defined as the clinical state in which diuretic response is diminished or lost before the goal of treatment has been achieved. Diuretic resistance has an adverse effect on clinical outcomes and is associated with a poor prognosis. This open-labeled study will evaluate the option to overcome this resistance in patients with partial of complete loss of the effect via random drug administration using an app. In the present study, the investigators will add the use of a treatment schedule prepared by the physician for each of the patients. This schedule includes a treatment regimen based on the drugs the patient is taking in a pre-determined random change within their approved therapeutic window to be administered by an app. Patients will be followed for 10 weeks and will be compared with their pre-intervention condition. The effect and safety of altering the treatment regimen will be assessed by the need for intravenous diuretics, hospitalizations and emergency department admission and by Kansas City Cardiomyopathy Questionnaire (KCCQ), 6 minutes walk test, creatinine level and pro BNP levels.
Virtual Care to Improve Heart Failure Outcomes (VITAL-HF)
Heart Failure With Reduced Ejection FractionThe purpose of this study is to evaluate how safe and effective a remote, digital intervention is that helps clinicians use and optimally adjust heart failure medications, compared to usual care medication use and adjustment, in participants with heart failure with reduced ejection fraction
ContraBand™: FIH Safety & Feasibility Study (RM-20-01)
Heart FailureLeft SidedThe ContraBand™ device is intended for treatment of heart failure patients who remain symptomatic despite the use of optimally tolerated guideline directed medical therapy. ContraBand™ is a transcatheter constriction device which is implanted in the left and right branch pulmonary arteries, causing a local reduction in the internal diameters of these arteries, and resulting in an elevation in systolic right ventricular pressure. This may result in repositioning the interventricular septum to a more normal anatomical position, and supporting it with a "counter-pressure" during systole of the left ventricle. This study is a first-in-human, early feasibility, multi center, prospective, interventional, open-label, single-arm study.
Endocalyx for Heart Failure
Chronic Heart FailureThe goal of this randomized, double-blind, placebo-controlled study is to assess whether the food supplement Endocalyx Pro reduces sodium and water excess in patients with chronic heart failure. The main questions it aims to answer are: To assess whether the food supplement Endocalyx reduces sodium and water excess in patients with chronic heart failure. To determine the contribution of different potential working mechanisms of Endocalyx in heart failure patients. To evaluate whether the food supplement Endocalyx will improve patient-reported outcomes such as fluid overload symptoms and quality of life. To confirm the previously demonstrated safety of Endocalyx in subjects with chronic heart failure. Participants will be randomized to Endocalyx Pro or Placebo daily for 8 weeks, and will be followed 12 weeks.
Empagliflozin in Heart Failure Dialysis Patients
Heart FailureHemodialysisEmpagliflozin is not still approved for glomerular filtration rate < 20 cc/min/1.73m2. Considering the cardiac and renal benefits of this drug, the evaluation of the safety and efficacy of Empagliflozin for heart failure dialysis patients seems to be mandatory.