Chronic Heart Failure

This pragmatic randomized crossover trial looks at the effect(s) of using a remote patient monitoring device (Heartfelt device) with health alerts to monitor the development of peripheral edema in patients with heart failure (HF). The hypothesis is that this passive measurement method will lead to better data availability, which in turn will improve patient care and reduce hospitalizations for the management of worsening HF (HF hospitalizations, HFHs) in nonadherent participants with chronic HF. The study objectives are: * Primary objective: Establish if the Heartfelt device is safe to use and effective at reducing HFHs. * Secondary objectives: 1. Establish the effect of the Heartfelt device on data availability compared to existing remote monitoring devices. 2. Establish the effect of the Heartfelt device on HF clinical outcomes. Participants will need to: * Install the device in their home for at least a year and up to 4 additional years after. * Reply to remote patient monitoring phone calls to follow the care plans.

Observational cohort randomized controlled study to study the influence of correction of ID by intravenous injection of ferric carboxymaltose (Ferinject®) on quality of life indicators, functional status in a cohort of patients with HFpEF.

The benefit of weight loss in patients with obesity and heart failure with reduced ejection fraction (HFrEF) is controversial. Semaglutide has shown cardiovascular (CV) risk-reduction and impact on CV risk factors including overweight, dysglycaemia and hypertension in subjects with type 2 diabetes (T2D). The STEP-HFpEF (Semaglutide Treatment Effect in People With Obesity and HFpEF) recently demonstrated, at 1-year, to not only reduce weight considerably, but also significantly improve health-related quality of life, functional status scores and 6-min walk distance in patients with heart failure with preserved ejection fraction (HFpEF). Also, the recently concluded SELECT trial was the first CV outcome trial with semaglutide in patients with overweight or obesity and established CV disease, including heart failure (but no T2D). Semaglutide demonstrated a 20% reduction in MACE, defined as the composite of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke. These landmark findings have important implications for clinicians -as they mean that weight loss and/or semaglutide as anti-obesity pharmacotherapy could be a treatment strategy for secondary prevention of CV disease in patients with overweight or obesity. It is, however, unknown whether weight loss with either calorie-restricted diet or semaglutide has beneficial effects in obese subjects with heart failure and reduced ejection fraction. Also it is unclear whether semaglutide has cardiovascular benefits irrespective of starting weight and amount of weight loss. Purpose: The study aims to investigate whether weight loss treatment with semaglutide is superior to weight loss with calorie-restricted diet in improving peak oxygen uptake in patients with obesity and heart failure with reduced ejection fraction.

Chronic heart failure (CHF) is a long-term condition in which the heart is unable to pump blood effectively. It can cause symptoms such as shortness of breath, fatigue, swelling in the legs, and reduced ability to perform daily activities. These problems often reduce a patient's quality of life and may lead to frequent hospital visits. This study will assess whether a mobile-based telemedicine program can improve the health-related quality of life of patients with chronic heart failure in Ethiopia. In this study, 70 adult patients with chronic heart failure will be included. They will be divided into two groups: 35 patients will receive routine care plus mobile-based telemedicine support, and 35 patients will receive routine care only. The mobile-based telemedicine program will include health education, medication reminders, lifestyle advice, and follow-up support delivered through phone calls and text messages over an 8-week period. Patients' quality of life will be measured at the beginning of the study and again after 8 weeks using a standard questionnaire called the Minnesota Living with Heart Failure Questionnaire (MLHFQ). The main goal of the study is to determine whether mobile-based telemedicine improves quality of life compared with routine care alone. The study may also help improve self-care behaviors, medication adherence, and symptom control among patients with heart failure. The findings may provide evidence to support the use of mobile health technologies as a simple and scalable approach to improve heart failure care in Ethiopia.

This is an observational study in which data from Japanese people with chronic heart failure who will be receiving vericiguat is studied. Chronic heart failure (HF) is a long-term condition where the heart does not pump blood as well as it should. Heart failure can lead to other serious medical conditions, and it can lead to hospitalization or death. The drug vericiguat works by increasing the activity of an enzyme called soluble guanylate cyclase (sGC). The sGC enzyme helps regulate the heart and blood circulation. Vericiguat is already available and approved for doctors to prescribe to people who have heart failure. A limited number of patients have been treated with vericiguat. Therefore information about its safety in a broader population and especially among Japanese people as well as for prolonged periods of treatment is still missing. In this study, the researchers want to learn more about how safe vericiguat is if used in Japanese people with long term HF. To see how safe vericiguat is, the researchers will collect the medical problems the participants have during the treatment with vericiguat under real-word conditions. They will particularly focus on the following: * high blood pressure * any medical problems due to combination of the study treatment vericiguat with nitrates and nitric oxide (NO) donors or with PDE5 inhibitors * medical problems in participants with liver problems or with reduced kidney function * medical problems in participants with low blood pressure below \<100 mmHg or with symptoms due to low blood pressure * any medical problems after prolonged periods of treatment with vericiguat. These medical problems are also known as "adverse events" (AEs) which may or may not be related to the study treatment. In addition, this study will gather information about how long vericiguat treatment can prevent death caused by cardiovascular problems such as heart attack and stroke compared to standard of care. Cardiovascular death (safety specification) will be assessed in a comparative manner with the control arm as the primary objective The participants will receive their treatments as prescribed by their doctors according to the approved product information. The data for this study will be collected using an electronic case report form (eCRF) and medical records. The following data from the study participants will be documented during visits that take place in routine practice: * underlying and concomitant diseases, * prior medication, * treatment duration, * laboratory parameters, * vital signs, * results of cardiac exams (e.g. cardiac ultrasound), * heart failure related hospitalization events, * adverse events. The data collection will start from the beginning of vericiguat/standard of care treatment and will cover a time period of 2 years unless no further information can be expected from the participant at a given point in time, or death. The total study duration will be six years, including data analysis and cleaning.

The goal of TAILOR-HF is to integrate clinical data, laboratory parameters, treatment patterns, and circulating biomarkers to identify factors that predict individual response to pharmacological treatment in patients with heart failure. TAILOR-HF is an observational study with protocol-mandated assessments scheduled at baseline and at 1, 3, and 6 months after enrolment. Additional follow-up data will be collected through telephone visits every 6 months until the last participant has completed the protocol-mandated 6-month visit.

This is a single-center, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of fecal microbiota transplantation (FMT) in elderly patients with heart failure with preserved ejection fraction (HFpEF). HFpEF is a common type of heart failure in older adults, often associated with poor quality of life and frequent hospitalizations. Recent research suggests that changes in gut bacteria may contribute to the progression of HFpEF. FMT aims to restore a healthy gut microbiome, which may improve heart function and reduce symptoms. Participants will be randomly assigned to receive either FMT or a placebo treatment. The primary goal is to compare changes in the Kansas City Cardiomyopathy Questionnaire (KCCQ) score between the two groups at 20 weeks. Secondary goals include assessing improvements in exercise capacity (6-minute walk test), NYHA functional class, and safety outcomes. The study will enroll 50 elderly patients (aged ≥60 years) with confirmed HFpEF. All participants will receive standard medical care for HFpEF throughout the study. This trial is sponsored by The First Affiliated Hospital of Air Force Medical University and conducted in accordance with ethical standards.

The purpose of this study is to determine whether people with CHF, who often have different gut bacteria from healthy, would benefit from replacing their gut bacteria with healthy donor bacteria (also known as Intestinal Microbiota Transplantation - IMT). IMT aims to restore healthy gut bacteria in patients with CHF, with previous studies showing its effectiveness, but further research is needed. IMT is an approved treatment for patients with infectious diarrhea. More than 10,000 IMTs are performed every year in the US. However IMT is not approved for patients with CHF, and thus considered investigational.

The goal of study is to evaluate the effects of an eight-week machine-based resistance training program on managing sarcopenia in older outpatients with chronic heart failure (HF) at Military Hospital 175.

A prospective-retrospective observational registry of patients diagnosed with chronic heart failure in the regions of the Russian Federation. The study is non-interventional and does not involve any interventions in clinical practice, the choice of treatment methods (including the type of medical device used and the method of surgical intervention) and examination. A control observation group is not intended.

The investigators hypothesize that the airway pressures generated by High Flow Oxygen Therapy could have a beneficial impact in patients with heart failure, particularly by lowering capillary pulmonary arterial pressures. However, results compared to Non-Invasive Ventilation are difficult to predict due to the lack of data in the literature.

A Study to Evaluate the Safety and Pharmacokinetics of AD-118 and AD-1181 Under Fasted Conditions in Healthy Adult Subjects

The goal of this observational, multicenter study is to evaluate whether AI-driven remote monitoring using a mini-invasive wearable device can improve clinical outcomes in adult patients (≥18 years) with chronic heart failure (CHF). The main questions it aims to answer are: * Can continuous remote monitoring reduce hospital admissions (emergency visits and hospitalizations) by 20% compared to standard care? * Does wearable-based remote monitoring improve functional, biochemical, and instrumental parameters in CHF patients? Researchers will compare patients using the wearable device (intervention group) to those receiving standard clinical follow-up (control group) to assess whether AI-driven monitoring leads to fewer hospitalizations, better disease management, and improved quality of life. Participants will: * Wear the EmbracePlus (Empatica Inc.) device continuously for six months (intervention group only). * Have their biometric data (SpO₂, HRV, EDA, respiratory rate, temperature, sleep quality) monitored remotely. * Receive automated alerts and teleconsultations if abnormal physiological changes are detected. * Attend scheduled follow-up visits (remote and in-person) for clinical evaluation and treatment adjustments. The study aims to provide real-world evidence on whether integrating wearable health technology with AI analytics can enhance CHF management and improve patient outcomes.

A cohort study on patients with type 2 diabetes to investigate possible biomarkers as predictors of chronic heart failure.

In this prospective, randomized, multicenter, open-label interventional clinical trial, the investigators' aim to test the effect of Cardiac Resynchronization Therapy (CRT) in cases of new-onset and persistent Left Bundle Branch Block (LBBB) occurring in the context of Transcatheter Aortic Valve Implantation (TAVI), in patients with moderately reduced left ventricular systolic function (35% \< EF \< 55%). The investigators hypothesize that in patients with persistent LBBB developing after TAVI and mildly reduced left ventricular systolic function (35% \< EF \< 55%), early postoperative CRT implantation favorably influences the process of myocardial reverse remodeling by reducing electromechanical dyssynchrony, thereby decreasing the combined endpoint of heart failure-related hospitalizations and mortality at one year.

The goal of this clinical trial is to investigate how vericiguat benefits adults with stable heart failure with reduced ejection fraction (HFrEF) who are already receiving guideline-directed medical therapy. The main questions are: * Does vericiguat improve right ventricular systolic function, measured by tricuspid annular plane systolic excursion (TAPSE)? * Does vericiguat favourably influence myocardial remodeling, fibrosis, angiogenesis, inflammation, metabolism, renal function, and hematologic balance? * Do genetic and oxidative stress profiles modify treatment response? Researchers will compare a group receiving vericiguat plus usual care with a group receiving usual care alone to assess structural, functional, and biomarker changes over 12 months. Participants will: * Have blood drawn at baseline and follow-up visits for biomarker, metabolomic, genetic, transcriptomic, and hematologic analyses, including platelet function testing * Perform oral glucose tolerance tests (OGTT) to assess insulin resistance * Undergo echocardiography, cardiac magnetic resonance imaging, and cardiac scintigraphy to evaluate heart structure, function, and perfusion * Attend follow-up visits at 1, 3, 6, and 12 months Open-label extension: After the 12-month randomized phase, participants originally assigned to usual care will be offered open-label vericiguat and followed for an additional 12 months. This exploratory extension will reassess study outcomes to evaluate the consistency and magnitude of response to vericiguat in the prior control cohort.

This is an observational study in which data from people with chronic heart failure (HF) with left ventricular ejection fraction (LVEF) ≥ 40%. who will be receiving finerenone are studied. The study is conducted to check the safety of finerenone after it is approved and available in South Korea. Observational studies use data that are collected as part of routine medical care and participants do not receive any advice or any changes to healthcare as part of the study. In this study, the data will be collected from participants who are receiving their usual treatment with finerenone as prescribed by their doctor according to the approved product information. Heart failure with LVEF ≥ 40% is a condition which occurs when the left side of the heart does not pump blood out to the body as well as it should. Over time, the body does not get the amount of oxygen it needs. This can lead to shortness of breath and tiredness, making it difficult for people to do their daily tasks. The study drug, finerenone, is already approved for doctors to prescribe to people with chronic heart failure. It works by blocking a specific receptor in the body called the mineralocorticoid receptor (MR). This helps reduce harmful effects in the heart, kidneys and blood vessels. Finerenone is different from older medicines in this group because it is more selective and may have fewer side effects, such as problems with the kidneys or high potassium levels in the blood. The participants in this study will receive finerenone as prescribed independently by their doctors during routine practice according to the approved product information. There have been studies in which researchers studied the effect and safety of finerenone in participants with chronic heart failure with LVEF ≥ 40%. These studies, however, included only a small number of South Korean participants. In this study, researchers will specifically gather data from South Korean participants to further understand the safety of finerenone. The main purpose of this study is to learn more about how safe and effective finerenone is in adults with chronic heart failure with LVEF ≥ 40% in South Korea within approved local label when used in everyday medical practice. To do this, researchers will collect any side effects or health problems that happen while patients are taking finerenone, and whether they are related to finerenone. In addition, doctors will also look at how well finerenone works by measuring: * Changes in investigator's treatment satisfaction with the treatment over time, including improvements in symptoms, quality of life and overall health status. * Time to dose change of finerenone (for example, increasing the dose if needed). Data will be collected from participants over one year after they enroll in the study or until they choose to leave the study. The data will come from participant's medical records or by interviewing the patient. In this study, only available data from routine care will be collected. No visits or tests are required as part of this study.

Heart failure (HF) is a chronic disease that has a strong impact on quality of life and is often accompanied by anxiety and depression symptoms that can contribute to poor treatment compliance. The overall management of heart failure is currently part of the recommendations and, alongside drug therapy and electrical devices that can be proposed, lifestyle changes (diet, physical activity) can help improve well-being. and perhaps patient prognosis. Yoga is an ancient practice, known to improve the emotional and physical well-being of individuals. There is no formal medical contraindication to this practice, which can be perfectly adapted to the patient's condition. However, very few patients with heart failure practice yoga. A few randomized trials with small numbers as well as the combined analysis of several studies have shown the benefit of yoga in heart failure. The main objective of the research is to demonstrate the improvement in the quality of life induced by the regular practice of yoga in the management of stabilized chronic heart failure patients. Secondly, we will evaluate the effectiveness of regular yoga practice on improving the clinical condition of chronic heart failure patients.

This is a prospective single-center cohort study conducted at The First Affiliated Hospital of Xinjiang Medical University, aiming to enroll 400 patients with chronic heart failure (including HFrEF, HFmrEF, HFpEF) and 200 healthy controls.We will collect clinical data (e.g., NYHA class, NT-proBNP), multi-omics samples (genome, proteome, metabolome, gut microbiome), and imaging indicators (e.g., EAT density, myocardial strain) from participants at baseline. For patients treated with SGLT2 inhibitors, we will also track dynamic changes in multi-omics during follow-up.The main purpose is to build a composite risk prediction model (integrating multi-omics and clinical indicators) to predict the 1-year composite endpoint (heart failure rehospitalization or all-cause death). Secondary goals include identifying specific molecular profiles related to heart failure phenotypes, exploring the "gut-heart axis" mechanism, and finding early biomarkers for SGLT2 inhibitor response.All participants will be followed up for at least 12 months, and the study will strictly comply with ethical norms and protect the privacy of participants.

B2278 is a human umbilical cord mesenchymal stem cell (HucMSCs) injection derived from the umbilical cord. It has the advantages of stronger immune regulation, stronger expansion capacity, lower immunogenicity, and greater accessibility. The preliminary research results indicated that the B2278 injection promote the polarization of macrophages towards a reparative state through paracrine action, directly promote angiogenesis and inhibited inflammatory responses, thereby exerting effects on myocardial repair and treatment of heart failure, and it is also safe and well-tolerated. This trial is a multi-center I/II phase clinical trial of the human umbilical cord mesenchymal stem cell injection solution, aiming to explore the dosage and regimen for the intramyocardial injection of B2278 in combination with coronary artery bypass grafting surgery for the treatment of chronic heart failure caused by chronic ischemic cardiomyopathy, and to evaluate the safety, tolerance and efficacy of allogeneic intramyocardial injection of the human umbilical cord mesenchymal stem cell injection solution in patients with chronic ischemic heart failure.

this study aims to investigate the effect of low vs high volume- high intensity interval training on functional capacity and quality of life in chronic heart failure patients

Heart failure is a chronic condition that can lead to frequent hospitalizations and reduced quality of life. This study aims to evaluate whether a nurse-led, face-to-face educational intervention can improve clinical stability, treatment compliance, and self-care behaviors among patients with heart failure after hospital discharge. Participants will be randomly assigned to either the intervention group, receiving a structured 30-minute educational session using the teach-back method, or the control group, receiving standard follow-up care. The primary outcome is clinical stability at three months, assessed using the Heart Failure Somatic Perception Scale. Secondary outcomes include self-care and medication compliance measured up to 12 months. The study will be conducted at the ASST di Lodi Heart Failure Clinic in Italy and is expected to last three years.

The objective of this project is to assess the effects of combined physical exercise and cognitive training interventions on cognitive and brain health in patients with heart failure (HF). Also, the role of sex on the effects of the interventions will be assessed.

The goal of this study is to investigate the effect of oral sucrosomial iron on exercise capacity and quality of life in patients with heart failure (HF) and iron deficiency (ID). The main question the study aims to answer is whether oral sucrosomial iron improved exercise capacity, assessed by six-minute walk test, and quality of life, assessed by Kansas City Cardiomyopathy Questionnaire, compared with placebo. One group of participants will receive treatment with oral sucrosomial iron and the other group will receive treatment with placebo.

Patients with coronary artery disease and undergoing high-risk percutaneous coronary intervention (PCI) are at increased risk of hemodynamic instability and poor outcomes. Mechanical circulatory support (MCS) devices may offer hemodynamic stabilization during PCI, potentially improving short- and long-term outcomes. The study rationale is to investigate the safety and clinical efficacy of temporary MCS with the iVAC 2L transaortic device in high-risk percutaneous coronary intervention. The transaortic system for short-term circulatory support with pulsatile blood flow iVAC 2L consists of an external membrane pump, a 17Fr diameter catheter for reversed blood flow (intake cannula) with a patented two-way rotary valve. The pump has two chambers, one for blood and one for helium, separated by a flexible diaphragm. The blood chamber connects to the catheter and the air chamber connects to a standard IABP console. The bi-directional valve is located 72 mm from the aspiration tip of the catheter and determines the direction of blood flow. The catheter is advanced retrogradely through the common femoral artery so that the tip is located in the left ventricular (LV) cavity and the valve is in the ascending aorta. Synchronized with the cardiac cycle via ECG, the device draws blood from the LV into the pump chamber during systole and ejects blood from the pump into the ascending aorta during diastole. The primary composite outcome is all-cause mortality, including acute myocardial infarction, stroke and TIA during hospitalization and at Day 360 of follow-up, expressed as a percentage of total patients.