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NCT05278962
The main purpose of this study is to observe outcomes of sodium-glucose co-transporter 2 inhibitors (SGLT2i) in heart failure (HF) patients with left ventricular assist devices (LVAD).
NCT07352891
DigiCare-HFrEF is an investigator-initiated, multicentre, randomised, open-label, endpoint-blinded, superiority trial designed to evaluate whether a structured digital remote-management platform can optimise guideline-directed medical therapy (GDMT) in patients with heart failure with reduced ejection fraction (HFrEF) after hospital discharge. Eligible adults (≥18 years) with a confirmed diagnosis of HFrEF within the past 3 months (left ventricular ejection fraction ≤40%) who are not optimally treated with GDMT-defined as at least two of the four foundational drug classes (ACEi/ARB or ARNi, β-blocker, MRA, SGLT2 inhibitor) either not initiated or prescribed at \<50% of the target dose-will be randomly assigned in a 1:1 ratio to digital remote management or usual care. In the intervention arm, patients will report symptoms and key physiologic measures (e.g., blood pressure, heart rate, and body weight) via the platform; an algorithm will perform risk stratification and generate GDMT optimisation suggestions and decongestion prompts, as well as a comprehensive management for core health metrics, which are reviewed and confirmed by clinicians before implementation. The primary endpoint is the change in GDMT score from baseline to 3 months (ΔGDMT).
NCT06148935
This is an observational study in which only data are collected from participants receiving their usual treatment. The study is done in people with chronic heart failure with reduced ejection fraction (HFrEF). HFrEF is a long-term condition in which the heart does not pump blood as well as it should. Blood and fluid may collect in the lungs, blood vessels, and tissues causing shortness of breath or tiredness. Over time, heart failure can lead to other serious medical conditions that may result in hospital stays and death. The study treatment vericiguat works by increasing the activity of an enzyme called soluble guanylate cyclase (sGC). sGC helps to regulate the heart and blood circulation. Vericiguat has already been studied in previous clinical studies and is available for doctors to prescribe to people with heart failure. This study will collect important data from real-world setting in Korea. The participants of this study are people with HFrEF who will receive vericiguat as prescribed by their doctors according to the approved product information The main purpose of this study is to learn more about how safe vericiguat is in the participants. To do this, researchers will collect data on all medical problems (also called adverse events) that the participants have during the study. Doctors keep track of all adverse events, even if they do not think they might be related to the study treatment. Further, researchers will collect data on how well vericiguat works and treatment patterns in the participants. For this, the following information will be collected: * occurrence of death due to heart and circulatory events * hospital stays due to heart conditions (failure) * dose levels of vericiguat and duration of treatment The data for this study will come from medical records and visits that take place in routine practice. Participants will be treated with vericiguat and observed up to 12 months or until death or they leave the study, whatever comes first.
NCT07349979
To evaluate whether percutaneous coronary intervention (PCI) with contemporary drug-eluting stents (DES) combined with guideline-directed medical therapy (GDMT), compared to GDMT alone, reduces the time to first occurrence of major adverse cardiovascular events (MACE) through 12 months in patients with ischemic cardiomyopathy and a left-ventricular ejection fraction (LVEF) ≤40%. MACE is a composite of cardiovascular \[CV\] death, spontaneous myocardial infarction (MI), any unplanned revascularization, heart failure (HF)-related rehospitalization, heart transplantation, requirement of device implantation (e.g., valvular treatment, pacemaker, or left ventricular assist device \[LVAD\]), or requirement of intravenous medications due to worsening heart failure in outpatients.
NCT06632483
This is an observational study in which data already collected from people with chronic HFrEF (heart failure with reduced ejection fraction) who have experienced worsening heart failure are studied. Chronic HFrEF is a long-term condition where the left side of the heart does not pump blood out to the body as well as it should. Blood and fluid may collect in the lungs, blood vessels, and tissues causing shortness of breath or tiredness. Over time, heart failure can lead to other serious medical conditions that may result in hospital stays and even death. The study drug, vericiguat, is already approved for doctors to prescribe to people with worsening of heart failure with chronic HFrEF in India. Vericiguat increases the activity of an enzyme called soluble guanylate cyclase (sGC), which relaxes the blood vessels, allowing more blood to flow through. As a result, the heart is able to pump better. The participants in this study are already receiving treatment with vericiguat as part of their regular care from their doctors. There is currently limited real-world data on the use of vericiguat. Furthermore, discussing whether vericiguat treatment should start early in people with heart failure can help doctors manage these people better. The main purpose of this study is to collect information about how well vericiguat works and how safe it is in Indian people with chronic HFrEF who have experienced worsening heart failure. To do this, researchers will collect the following information: * participants' characteristics, including age, sex, height, weight, and medical history * additional medicines participants have taken with vericiguat * other treatment options participants have taken for the treatment of heart failure * levels of NT-pro BNP\* in participants' blood at least one month before taking vericiguat (\*NT-proBNP is made by heart muscles. People with heart diseases have increased levels of NT-proBNP in their blood. Measuring NT-proBNP levels in the blood can help doctors identify heart disease.) * number of participants from India, divided into four zones-North, South, East, and West * categorization of participants based on how heart failure limits physical activity and classification of heart failure by cause * change in heart function measured by how much blood the left side of the heart can pump out * number of hospitalizations and number of participants who died due to heart-related and non-heart-related events * number of participants who experienced low blood pressure or fainting after starting treatment with vericiguat * participants who discontinued treatment with vericiguat, due to low blood pressure or fainting The data will come from the participants' hospital, medical and electronic healthcare records. Data collected will be from Indian people with chronic HFrEF who started taking vericiguat between September 2022 and August 2023. Researchers will track participants' data and will follow them until Feb 2024. In this study, only available data from routine care are collected. No visits or tests are required as part of this study.
NCT07472595
The biological process that underlies the pathogenesis of heart failure (HF) is termed cardiac remodeling. Pathological cardiac remodeling includes structural and functional change of the heart. Structural cardiac remodeling in HF include dilatation and/or hypertrophy of cardiac chambers, in particular the left ventricle (LV), but can also involve the right ventricle (RV) and both atria; moreover, cardiac valves, in particular the mitral valve, have been shown to undergo adaptive enlargement in HF to counteract leaflet tethering that leads to functional regurgitation 1. Functional changes of the heart in HF includes reduction of LV systolic and diastolic function, ischemia, abnormalities in myocardial deformation, and alteration in intracardiac vortex flow formation and energetics. At the tissue level, cardiac remodeling is marked by interstitial reparative and replacement fibrosis and inflammation. Cyclic guanosine monophosphate (cGMP) is an intracellular second messenger molecule that is important in the pathogenesis of HF. The main kinase effector of cGMP, protein kinase G, counteracts many biological derangements contributing to HF in experimental models. The production of cGMP in the heart, kidney, lung, liver, and brain is triggered by stimulation of either soluble guanylyl cyclase (sGC) or particulate guanylyl cyclase (pGC), and regulated by endogenous receptor ligands such as nitric oxide (NO) and natriuretic peptides (NPs). In the cardiovascular system, cGMP pathway is involved in the pathogenesis of myocardial fibrosis, inflammation, myofilament insensitivity, vascular dysfunction, and cardiomyocyte hypertrophy 2. Vericiguat is a direct sGC stimulator with a dual mode of action: it sensitizes sGC to the body's own NO and increases sGC activity in the absence of NO, causing vasorelaxation, antiproliferation, and antifibrotic effects. A recent randomized trial, Vericiguat Global Study in Subjects with Heart Failure with Reduced Ejection Fraction (VICTORIA), found that vericiguat reduced a composite endpoint of hospitalization for HF and cardiovascular death in high-risk patients with HF with LV ejection fraction (LVEF) less than 45 percent 3. The mechanisms underlying the clinical benefit of vericiguat are uncertain but may include effects on fibrosis and inflammation. Evaluation of LV size by 2D imaging has traditionally be challenging owing to technical limitations, such as foreshortening leading to underestimation of LV volumes using the Simpson's method. Latest advance in 3D echocardiography technology and automated cardiac functional analysis software has revolutionized evaluation and monitoring of LV and LA function in patients with HF. 3D echocardiography allows accurate measurement of LV, LA, and RV volumes and ejection fraction without needing any geometric assumption, with results reproducible and comparable to cardiac magnetic resonance, the imaging gold standard for chamber quantification. Furthermore, speckle tracking echocardiography allows evaluation of cardiac muscle deformation, which are more sensitive and load-independent markers of cardiac function. Echocardiography has the advantage of being wide available, with no harmful effect, and can be repeated in follow-up of patients. Our group is experienced in the evaluation of the cardiac structure and function in patients with HF using 3D, speckle tracking, and other advanced echocardiographic techniques 4-11. The investigators therefore propose to conduct a pilot study to examine the effect of vericiguat on cardiac remodeling in patients with HF and reduced EF (HFrEF) with particular attention paid to the remodeling of LV and LA, using novel imaging techniques including 3-dimensional (3DE), with automated 3D analysis, and speckle tracking echocardiography.
NCT07470554
This retrospective study will take advantage of an existing EU-funded dataset, the BIOlogy Study to TAilored Treatment in Chronic Heart Failure (BIOSTAT-CHF), which was designed to identify biomarkers related to the response to guideline directed medical therapy, and coordinated by UMCG. The availability of this comprehensive dataset of patients with severe HFrEF, prospectively and consistently collected, with the possibility to access a biobank to re-assay samples with novel biomarkers, provides a unique opportunity to derive preliminary data about the interaction between biomarkers of congestion and diuretic doses, that were prescribed based on clinical judgement, and therefore derive a machine learning-based algorithm than could be tested to guide the management of diuretic therapy
NCT07214376
The goal of this clinical study is to evaluate the safety and efficacy of percutaneous pulmonary artery denervation with the Multi-Pole Pulmonary Artery Radiofrequency Ablation Enhancor System in patients with combined pre- and post-capillary pulmonary hypertension (CpcPH) associated with left heart disease (LHD). This randomized control trial will compare the investigational device (The Enhancor System) to control (medical therapy.) Participants who will consist of patients with chronic heart failure (HF) who are receiving maximally tolerated guideline-directed medical therapy (GDMT) for left heart failure, are clinically stable, and who have been diagnosed with CpcPH by right heart catheterization (RHC), will be treated with PADN and followed for 3 years.
NCT07057466
This study aims to improve the early detection of undiagnosed heart disease, which causes serious health issues, hospital admissions, and high healthcare costs. Researchers are exploring how artificial intelligence (AI) can analyse routine heart tests, called electrocardiograms (ECGs), to detect heart problems. These tests can be done using both traditional ECG machines and portable, wearable devices like smartwatches, making it easier for people to monitor their heart health at home. While AI has shown promise using past data, this study will involve the collection of ECG data and subsequent testing of its accuracy in real-world settings to ensure it works well for both doctors and patients. The goal is to see if AI can identify conditions like heart muscle weakness, valve issues, and high lung pressure from the ECG data of patients. The researchers will also compare AI's detections with other blood tests commonly used to diagnose heart disease. The AI models that will be used are being tested for research and validation purposes only. They will not be used for clinical decision-making or providing information to influence diagnosis, treatment, or patient care during the study. The AI outputs are not shared with clinicians and will have no impact on the care pathway. This research will demonstrate if AI-powered ECG analysis - whether from traditional or portable devices - can provide a low-cost, non-invasive way to detect heart disease early and improve health assessments.
NCT04237701
The Yale HF Registry is a live EHR based registry that allows for retrospective and real-time monitoring of Heart Failure case across the Yale New Haven Health System.
NCT06229678
The study team will examine the effects of elevated plasma ketone levels following initiation of SGLT2 inhibitor therapy in high-risk type 2 diabetes mellitus (T2DM) individuals with heart failure (HF) with reduced ejection fraction (HFrEF) providing an energy-rich fuel that is taken up with great avidity by the myocardium, to measure change in Left Ventricle diastolic and systolic function
NCT07380555
This clinical trial aims to find out if using an artificial intelligence (AI) decision support system can help doctors better manage medications for people with heart failure with reduced ejection fraction (HFrEF). The main goal is to see if this approach can lower the chance of patients being hospitalized for heart failure or dying from heart-related causes compared to standard care. About 1,200 participants from 60 hospitals will take part in this study. The hospitals, not the individual patients, are randomly assigned to one of two groups: AI-Guided Group: Doctors at these hospitals will receive medication recommendations from an AI system based on patient health data. Standard Care Group: Doctors at these hospitals will manage medications as they normally would, without AI assistance. All participants will have regular check-ups, both remotely every 30 days and in-person at 3, 6, and 12 months. The study will last about 12 months for each participant.
NCT07355088
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.
NCT07311109
This study aims to investigate whether adjunctive hyperbaric oxygen therapy, compared to guideline-directed medical therapy with the "New Four Pillars" (ARNI/ACEI/ARB + β-blocker + MRA + SGLT2 inhibitor) alone, improves cardiac function in patients with chronic heart failure, and to evaluate its efficacy and safety.
NCT05093933
The purpose of this study is to evaluate the efficacy and safety of vericiguat in participants with chronic heart failure with reduced ejection fraction (HFrEF), specifically those with symptomatic chronic HFrEF who have not had a recent hospitalization for heart failure or need for outpatient intravenous (IV) diuretics. The primary hypothesis is that vericiguat is superior to placebo in reducing the risk of cardiovascular death or heart failure hospitalization.
NCT07283666
Investigators will evaluate the effectiveness of an audit and feedback performance improvement strategy in which cardiology providers receive quarterly emails on ambulatory quality improvement goals.
NCT00610051
This is a global multicenter, doubleblind, placebo-controlled, randomized, parallel-group study that compares ALP-1 given in a continuous infusion ( compared to placebo), 250mcg/day on majore outcomes up to 6 months after randomization in participants with advanced HF with reduced ejection fraction(HFrEF).
NCT06215911
The purpose of this study is to evaluate the safety and effectiveness of tovinontrine compared to placebo to lower NT-proBNP in patients with chronic heart failure with reduced ejection fraction.
NCT05642507
This is a randomized, double-blind, placebo-controlled two-part study with a multiple escalating dose phase followed by a cohort expansion phase to assess safety, tolerability, pharmacokinetics and pharmacodynamics of AC01 in patients with heart failure with reduced ejection fraction (HFrEF).
NCT06697353
This is an observational study in which data already collected from people with chronic heart failure is studied. Chronic HFrEF is a long-term condition where the left side of the heart does not pump blood out to the body as well as it should. Blood and fluid may collect in the lungs, blood vessels, and tissues causing shortness of breath or tiredness. Over time, heart failure can lead to other serious medical conditions that may result in hospital stays or even death. The study drug, vericiguat, is already approved for doctors to prescribe to people with chronic HFrEF in Japan. Vericiguat increases the activity of an enzyme called soluble guanylate cyclase (sGC), which relaxes the blood vessels, allowing more blood to flow through. As a result, the heart is able to pump better. The participants in this study are already receiving treatment with vericiguat (newly initiated) as part of their regular care from their doctors. There is currently limited real-world data on the use of vericiguat in Japanese people. Therefore, more research is needed on larger groups of Japanese people for a longer period to understand the effects of use of vericiguat. The main purpose of this study is to collect information about how well vericiguat is used in Japanese people with heart failure who initiate vericiguat treatment. To do this, researchers will collect the following information for participants who newly initiated vericiguat: occurrence of death due to heart and blood vessel related events occurrence of death due to any reason hospital stays due to heart failure a combination of hospital stays due to heart failure or occurrence of death due to heart and blood-vessel related events a combination of occurrence of death due to any reason or hospital stays due to heart failure In addition, researchers will collect the following information: participants' characteristics, including age, sex, height, weight, and medical history how well did the participants follow their prescribed treatment with vericiguat over the year after starting it how long did the participants continue to take vericiguat over the year after starting it changes in the dose of vericiguat in the participants over the year after starting it other treatment options participants have taken for the treatment of heart failure changes in laboratory values and other test results before and after treatment with vericiguat The data will come from the participants' hospital records provided by the Medical Data Vision Co., Ltd. They will cover the period from September 2016 to July 2024. Researchers will track participants' data and will follow them for a maximum of one year after starting treatment with vericiguat, or until any of the following happens: the participant dies the participant cannot be tracked anymore the end of the study In this study, only available data from routine care are collected. No visits or tests are required as part of this study.