Sotagliflozin in Heart Failure With Preserved Ejection Fraction (HFpEF) Patients
Heart Failure With Preserved Ejection FractionThe clinical benefits of the dual Sodium-Glucose cotransporter (SGLT) 1 and 2-inhibition have recently been reported in two clinical trials. The SOLOIST reported the benefits of sotagliflozin in Type-2 Diabetes Mellitus (T2DM) patients hospitalized for worsening of Heart Failure (HF), while the SCORED involved T2DM patients with Chronic Kidney Disease (CKD). It is worth noting that not only did the event curves separate within the first week post-treatment, but the effects of sotagliflozin on HF-related outcomes were observed regardless of Left Ventricular Ejection Fraction (LVEF) values and did not seem to attenuate with increasing LVEF as seen with empagliflozin and sacubitril/valsartan. Despite the favorable outcomes, the mechanism(s) of action through which sotagliflozin exerts these benefits remains unclear. The present study aims to investigate the potential (non-glucose dependent) "cardio-renal" pleiotropic effects of sotagliflozin in a mechanistic, randomized, double blind, placebo-control trial in HF patients with preserved ejection fraction (HFpEF). Comparisons between treatment groups will be made using cardiac MRI, CPET, 6-MWT and KCCQ-12.
Canagliflozin in Patients With Acute Decompansted Heart Failure
Chronic Heart FailureAcute Heart Failure1 moreThe study aims to investigate the efficacy and safety of the early initiation of canagliflozin treatment in hospitalized heart failure patients with volume overload (warm-wet) who require the use of I.V loop diuretic during the hospitalization period.
NoYA RAISE Trial II (Radiofrequency Ablation-Based Interatrial Shunt for Heart Failure)
Heart FailureA Prospective, Multiple Center, and Objective Performance Criteria Study to Evaluate the NoYA™ Radiofrequency Interatrial Shunt System manufactured by NoYA Medtech (Hangzhou) Co., Ltd. for the Treatment of Chronic Heart Failure with Elevated Left Atrial Pressure.
Effectiveness of a Cardiac Rehabilitation Program in Elderly Patients With Heart Failure.
Heart Failure With Preserved Ejection FractionSarcopenia2 moreThe main objective of the study is to assess the effectiveness of a cardiac rehabilitation program on functionality, measured by kinematic analysis, cardiorespiratory capacity, and ventricular ejection fraction in elderly patients with heart failure (HF). Other objectives will be; 1) to validate the kinematic analysis as an objective functional assessment that allows performing a functional stratification based on the severity of impairment ("kinematic phenotypes"), as well as to identify those patients who responders or are not responders to the cardiac rehabilitation program; 2) to develop a functional index that includes objective functional parameters, biomechanical biomarkers (heart and musculoskeletal echography) and physiological biomarkers (maximum consumption of oxygen (VO2 max), maximum heart rate (HR max) and blood lactate levels; 3) to analyse the degree of concordance of biomechanical biomarkers with functional tests normally used in clinical practice and with imaging and physiological biomarkers. A randomized, controlled, crossover clinical trial will be carried out at the Hospital Regional Universitario de Málaga. Clinically stable HF patients ≥70 years old will be included. The cardiac rehabilitation program will last 12 weeks and will follow the recommendations of the European Association of Cardiovascular Prevention and Rehabilitation. The patients will perform different functional tests, which will be at baseline, at 3 months and 6 months of follow-up.
Image Fusion of SPECT MPI and Fluoroscopy Venography to Guide LV Lead Placement for Improved CRT...
Chronic Heart FailureCRT response will be significantly better using image fusion of SPECT MPI and fluoroscopy venogram to guide LV lead placement at the latest activation segment without scar than standard-of-care implantation.
CORolla® TAA for Heart Failure With Preserved Ejection Fraction (HFpEF) and Diastolic Dysfunction...
Diastolic Heart FailureDiastolic DysfunctionThe study objective is to demonstrate safety and feasibility of the CORolla® TAA during 12 months of follow up, and to evaluate the performance of the therapy in relieving symptoms and restore diastolic function in patients with heart failure and preserved ejection fraction.
Flexible vs. Fixed Diuretic Regimen in the Management of Chronic Heart Failure: A Pilot Study
Heart FailureHeart DiseasesHeart failure is a major cause of death and hospitalization in Canada. Many of the symptoms experienced by patients with heart failure relate to having fluid accumulate in the lungs causing difficulty breathing, swelling in the legs, and an increase in weight. Thus, one of the cornerstones of managing heart failure includes the use of medications known as diuretics that target the kidneys to reduce fluid accumulation via urination. Deciding on the correct dose of this medication can be quite nuanced as under-dosing can lead to accumulation of fluid, and over-dosing can dehydrate patients and potentially result in lightheadedness/fainting and damage to the kidneys. Currently, options for prescribing diuretics for heart failure include 1) giving patients a regular, fixed dose or 2) having patients monitor their daily weight as a surrogate of their fluid status and then take a dose of diuretic based on a pre-prepared scale. The rationale behind the flexible weight-based diuretic scale is that it can potentially detect early fluid accumulation and thus possibly prevent hospitalization or ED visits, and it also avoids over-dosing and potentially dehydrating patients. Currently, it is not clear whether the flexible diuretic regimen is better than the fixed-dose regimen in preventing ED visits, hospitalizations, kidney damage, or death and as such, this pilot study will directly compare the two commonly used regimens in the management of chronic heart failure patients.
RCT of Implantable Defibrillators in Patients With Non Ischemic Cardiomyopathy, Scar and Severe...
Heart FailureBRITISH is a UK multicentre trial of patients who have been diagnosed with heart failure due to Non-Ischemic Cardiomyopathy (NICM, or heart failure that is not caused by blocked heart arteries. Participants will be randomised into two groups. Half the participants will receive an Implantable Cardioverter-Defibrillator (ICD) and the other half will not. The aim of the study will be to compare all-cause mortality (death from any cause) between these two groups at 36 months, and longer-term to 10 years. The study has the potential to change international heart failure treatment guidelines and to improve how patients with this condition are managed.
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on...
Heart Failure With Reduced Ejection FractionIron Deficiency1 moreThis study will address whether the additional use of Ferric Derisomaltose on top of standard care will improve exercise capacity and quality of life in patients with acute heart failure and iron deficiency. One group of participants will receive treatment with Ferric Derisomaltose and the other group will receive normal saline 0.9% as placebo.
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on...
Heart Failure With Preserved Ejection FractionIron Deficiencies1 moreThis study will address whether the additional use of Ferric Derisomaltose on top of standard care will improve exercise capacity and quality of life in patients with acute heart failure and iron deficiency. One group of participants will receive treatment with Ferric Derisomaltose and the other group will receive normal saline 0.9% as placebo.