Loading clinical trials...
Loading clinical trials...
Showing 1-20 of 1,205 trials
NCT05224557
The goal is to review cardiac biomarkers present on admission between African American patients with new onset Heart Failure compared to a comparable cohort of Caucasian patients to establish whether there is a clinically significant difference between the two groups regarding cardiac biomarker levels and initial Heart Failure severity. Hypothesis: Cardiac biomarker levels in African American patients with new onset Heart Failure with Reduced Ejection Fraction will be significantly lower than a Caucasian cohort with new onset Heart Failure with Reduced Ejection Fraction.
NCT07482865
A prospective, multi-center, open label, randomized controlled, superiority trial to compare clinical outcomes between routine distal perfusion catheter (DPC) insertion versus provisional distal perfusion catheter (DPC) insertion in the occurrence of sign or symptom of acute limb ischemia in patients undergoing mechanical circulatory support (MCS) through femoral artery approach.
NCT07057323
The purpose of this study is to evaluate the efficacy of CS Reducer implantation in patients with HFpEF and CMD on left ventricular filling pressures, specifically invasive measurement of PAWP during standardized exercise.
NCT06923514
Heart failure is showing a trend of affecting younger individuals. Middle-aged heart failure patients are often the economic backbone of their families. Studies have also pointed out that approximately 38.5% of patients with acute heart failure are re-hospitalized within a year of discharge due to worsening symptoms. Patients with lower health literacy tend to have poorer health outcomes and higher re-hospitalization rates. However, there is limited research on the life and work stress, health literacy, and quality of life of middle-aged heart failure patients. Therefore, this study aims to use machine learning to analyze and predict the correlations between health literacy, stress, and quality of life in heart failure patients. This research is a cross-sectional correlational study, adopting convenience sampling. The study subjects are cardiology patients aged 18-65 diagnosed with heart failure classified as NYHA II or above by specialists at a regional teaching hospital in northern Taiwan. Data collection took place in the outpatient and inpatient departments of cardiology and cardiothoracic surgery. Structured questionnaires were used for one-on-one interviews, including basic demographic information of heart failure patients, the Chinese version of the European Health Literacy Survey Questionnaire (HLS-EU-Q47), the Chinese version of the Brief Resilience Scale (BRS), the Perceived Stress Scale (PSS), and the Minnesota Living with Heart Failure Questionnaire (MLHFQ). Data will be recorded using Excel, and statistical analysis will be conducted using SPSS version 22. Descriptive statistics such as percentages, means, and standard deviations will be used to describe the demographic and variable distributions. Independent t-tests, ANOVA, and Pearson correlation coefficient will be used to analyze correlations between variables. Machine learning will be employed to analyze and predict quality of life factors in heart failure patients. It is hoped that the results of this study can provide references for nursing practice, help with clinical patient assessment, and improve the quality of care for patients.
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.
NCT05592847
The purpose of this study is to examine if educational intervention in high risk patients can lead to decreased hospital readmissions when compared to patients who are not in the intervention program. Additionally, to determine patient satisfaction with the educational program.
NCT07191730
Cancer treatments have improved substantially over the past decades, but some effective therapies such as anthracyclines and HER2-targeted agents are associated with severe cardiovascular adverse effects, including heart failure. Existing cardiovascular risk prediction scores have limited evidence in this setting. The ML-CardioTox study is a prospective, multicenter, observational cohort conducted in 15 centers in France. The primary objective is to develop a one-year prediction score for cancer therapy-related cardiotoxicity using machine learning methods. A dedicated software platform will be used to standardize data collection and support integration of artificial intelligence tools. A total of 600 patients treated with anthracyclines or HER2-targeted therapies in cardio-oncology clinics will be enrolled over a one-year inclusion period starting in December 2024, with a 12-month follow-up. The primary endpoint is the occurrence of cardiotoxicity as defined by the 2022 European Society of Cardiology guidelines (hospitalization for heart failure, initiation or escalation of diuretic therapy, decline in cardiac function on imaging, or increase in cardiac biomarkers such as troponin or natriuretic peptides). Secondary objectives include comparison of the predictive performance of the machine learning-derived score with the established HFA-ICOS risk score. Patients will be managed according to routine clinical practice. This study aims to improve prognostic stratification tools for patients receiving anthracyclines or HER2-targeted therapies, with the goal of better identifying those at high risk of developing cardiotoxicity during follow-up.
NCT04506606
This research in Veterans with heart failure with preserved ejection fraction (HFpEF) will provide new information on the mechanisms determining the patients' exercise intolerance and the efficacy of regular physical activity to improve this shortcoming by alleviating the patients' neurocirculatory abnormalities. Specifically, the investigators will focus on the role of nerves originating in working limb muscles in determining the patients' exercise intolerance and compromised fatigue resistance before and after a chronic exercise intervention. By focusing on a specific mechanism, this project will evaluate the validity of exercise as an alternative treatment strategy with the overall purpose of improving the quality of life of Veterans with HFpEF.
NCT07484009
This clinical trial aims to determine whether a ReDS-guided treatment strategy is superior to the current standard of care for adults hospitalized with heart failure. Additionally, the study will evaluate the safety and cost-effectiveness of this approach. The study seeks to answer the following key questions: 1. Does the ReDS-guided strategy reduce the risk of cardiovascular events during the first month following hospital discharge? 2. What is the safety profile of this treatment strategy? Researchers will compare the ReDS-based strategy against the current standard of care. All participants will: * Undergo daily assessments using the ReDS device throughout their hospitalization. * Attend two follow-up visits post-discharge, scheduled at 2 weeks and 30 days.
NCT05492500
The primary purpose of this clinical trial is to compare the effects of study medicine (Ponsegromab/PF-06946860) with a placebo (an injection that looks like the study medicine but does not contain the active medicine) to find out if the study medicine is better than the placebo (an injection that looks like the study medicine but does not contain the active medicine) for treatment of symptoms related to heart failure. Participants will not know which treatment group they are assigned to. Most participants in this study will receive the study medicine or placebo by shots under the skin every four weeks. People may be able to participate in this study if they have heart failure. Participants will take part in this study for about 9 months. During this time participants will visit the study clinic once a month. A separate PK cohort within this clinical trial will receive open-label study medicine (Ponsegromab/PF-06946860) only. Participants in this open-label, PK cohort will not receive placebo. These participants will receive the study medicine by shots under the skin every four weeks. People may be able to participate in this study cohort if they also have heart failure. Participants will take part in the open-label, PK cohort for about 7 months.
NCT06682260
This study aims to understand how nitroglycerin affects patients with acute heart failure, a condition where the heart struggles to pump blood effectively, leading to fluid buildup and breathing difficulties. Nitroglycerin relaxes blood vessels to ease the heart's workload and may help reduce fluid buildup. The investigators hypothesize that nitroglycerin can increase blood flow from the heart and promote urine production, which may reduce congestion in AHF patients. By studying heart function, blood volume, and fluid levels during treatment, the goal is to identify which patients may benefit most from nitroglycerin therapy.
NCT07192952
Researchers are looking for a better way to treat children and young adults who have heart failure with left ventricular systolic dysfunction (LVSD). Heart failure with left ventricular systolic dysfunction (LVSD) is a condition where the left side of the heart is weak and struggles to pump blood effectively, leading to symptoms like shortness of breath, fatigue, and poor growth. The study treatment, finerenone (also called BAY94-8862), is under development to treat newborns, children, and young adults with heart failure and LVSD. It works by blocking a protein that contributes to inflammation, scarring, and thickening in the heart and blood vessels, which may help the heart pump more blood effectively. The main purpose of this study is to learn about how safe finerenone is and how well it works in the long-term treatment of heart failure and LVSD. To understand how safe the treatment is, the study team will gather information on the number of patients who experience medical problems after taking finerenone, also known as "treatment emergent adverse events" (TEAEs). Additionally, they will collect blood samples to measure levels of an electrolyte called potassium and monitor blood pressure. They will also assess kidneys function using the estimated glomerular filtration rate (eGFR). In this study, which is an extension of the earlier done FIORE study, finerenone will also be studied in newly enrolled newborns under 6 months with heart failure and LVSD and children and young adults from the FIORE study. The participants will be aged from newborns up to 18 years. All the participants will continue to receive their standard treatment as routine care for heart failure, along with finerenone during the study. The participants will be in the study for around 10 to 11 months, depending on whether they rolled-over from the FIORE study or are newly enrolled newborns and infants \<6 months of age. They will take study treatment for up to 9 months. During this period, at least 6 visits are planned for participants. During these visits, the study team will: * have their blood pressure, heart rate, temperature, respiratory rate, height and weight measured * have blood samples taken * have physical examinations * have their heart examined by an electrocardiogram and echocardiography * answer questions about their medication and whether they have any adverse events, or have their parents or guardians' answer * for newborns and infants, evaluate the acceptability of the study drug formulation through parents or guardians' feedback. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. The doctors will check the participants' health a month after the participants take their last treatment.
NCT04784351
This is a retrospective observational study drawing on data from the Brigham and Women's Home Hospital database. Sociodemographic and clinic data from a training cohort were used to train a machine learning algorithm to predict length of stay throughout a patient's admission. This algorithm was then validated in a validation cohort.
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.
NCT04419480
Pilot Prospective Randomized Unblinded Pragmatic Trial of Pulmonary Artery Hemodynamic Monitoring Following Hospitalization for Cardiogenic Shock
NCT07105007
Heart failure (HF) is a growing health and economic burden around the globe, and it remains a leading cause of morbidity and mortality among the general population. HIV is recognized as an independent risk factor for HF, due to direct and indirect effects. Furthermore, people living with HIV (PLWH) now have an increased life expectancy due to the evolution and widespread use of antiretroviral therapy (ART), leading to a rising burden of cardiovascular disease (CVD) and HF among this population. Yet, the provision of appropriate guideline-recommended cardiovascular care is lower in PLWH compared to the general population, and there are no studies testing HF prevention interventions focused on PLWH. Current guidelines for HF management highlight the importance of a healthy lifestyle in preventing and treating HF. Among PLWH, tailored, innovative, and sustainable exercise delivery models are necessary to overcome barriers and increase physical activity (PA) adherence in this population. Building on the research team's prior mixed methods work and research expertise on exercise trials for PLWH, the investigators propose the Hybrid Exercise Intervention for Cardiovascular Health of People living with HIV (HEICA-HIV). HEICA-HIV is a novel multi-component 8-week intervention that will simultaneously deliver a supervised center-based (once a week) and a tailored home-based (twice a week) exercise intervention, together with exercise and cardiovascular health education. It will also involve behavioral coaching and mobile health support. The investigators evidence suggests that, by providing weekly exercise supervision together with a home-based prescription, the investigators can overcome difficulties associated with home-based programs (e.g., less intensive exercise training, less social support, and less face-to-face monitoring), and still observe the augmented health benefits obtained from supervised programs. Additionally, by requiring less time at the training center, this hybrid model can help with time restraints and transportation issues affecting marginalized populations, potentially increasing long-term exercise adherence in those who need it most. In this initial stage, HEICA-HIV will be focused on improving time in moderate-to-vigorous physical activity (MVPA). International guidelines recommend that every adult should engage in at least 150 minutes of MVPA per week in order to achieve optimal health benefits.
NCT07471802
The autonomic nervous system (ANS) plays a crucial role in cardiovascular regulation by modulating heart rate in response to endogenous and environmental stimuli. Heart rate variability (HRV) analysis has been widely used as a non-invasive tool to assess autonomic function and the balance between sympathetic and parasympathetic activity. Although the physiological interpretation of some HRV parameters remains debated-particularly the low-frequency (LF) spectral component as an index of sympathetic activation-HRV remains an important method for evaluating autonomic cardiovascular control. Reduced HRV has been associated with adverse outcomes in several pathological conditions and physiologically declines with aging, mainly due to progressive neuronal loss at central and spinal levels. Among conditions characterized by autonomic dysfunction, cardiovascular autonomic neuropathy (CAN) represents a common complication of diabetes mellitus (DM) and metabolic syndrome. CAN, defined as impairment of autonomic control of the cardiovascular system, develops early in the disease course and is associated with increased mortality and a higher risk of cardiovascular and renal complications. Sodium-glucose cotransporter 2 inhibitors (SGLT2i), initially developed as glucose-lowering agents, have demonstrated significant cardiovascular and renal protective effects beyond glycemic control. Growing evidence suggests that these drugs exert sympathoinhibitory effects that may be beneficial not only in diabetic patients but also in conditions characterized by sympathetic overactivity. Preclinical and clinical studies have shown that SGLT2i influence autonomic regulation, including sympathetic control of renal function, with reported improvements in 24-hour blood pressure regulation and HRV parameters. Large randomized trials have further confirmed the cardioprotective effects of SGLT2i therapy. Studies such as EMBODY, EMPEROR-Reduced, and EMPEROR-Preserved have demonstrated improvements in HRV indices and significant reductions in cardiovascular death and hospitalization for heart failure, irrespective of diabetic status. Despite these findings, the mechanisms underlying these benefits remain incompletely understood. While reduced sympathetic activity has been proposed as a key mechanism, emerging evidence suggests that SGLT2i may also enhance vagal modulation. Therefore, the present study aims to investigate, in a larger population, the effects of SGLT2i therapy on sympathovagal balance using both spectral HRV parameters and additional indices, including the parasympathetic nervous system index (PNSi), sympathetic nervous system index (SNSi), and the Baevsky Stress Index.
NCT05686317
This is a prospective, multi-center, randomized, sham-controlled, double-blinded (participant and outcomes assessor) clinical trial.
NCT05647213
The goal of this clinical trial is to test the safety of lab-grown heart cells made from stem cells in subjects with congenital heart disease. The main questions it aims to answer are: * Is this product safe to deliver to humans * Is the conduct of this trial feasible Participants will be asked to: * Agree to testing and monitoring before and after product administration * Receive investigational product * Agree to lifelong follow-up Researchers will compare subjects from the same pool to see if there is a difference between treated and untreated subjects.
NCT06206512
This research study is being done to compare the effectiveness two drugs: an Extended Release Torsemide (ERT) versus generic Immediate Release Torsemide (IRT) in reducing the worsening of symptoms of Overactive Bladder (OAB, i.e., frequency, urgency, or urgency incontinence) in patients with chronic congestive heart failure (CHF). This study will include CHF patients who experience worsening (OAB) symptoms with use of a loop diuretic. The total duration of the study is about eight weeks with a total of nine visits. There will be a screening visit that lasts one to two hours. The screening visit includes history and physical exams, blood draws, and urine analysis. If eligible for the study, participants will receive either generic torsemide or extended release torsemide for the first four weeks. Participants will do a virtual research visit on week one, two and three to submit a symptom diary and answer a questionnaire about urinary symptoms. At four weeks, history and physician exam will be done and blood will be collected. Participants will be assigned to receive either extended release torsemide (if they initially received generic torsemide) and generic torsemide (if they initially received extended release torsemide) for the next four weeks. Participants will attend virtual research visits on week five, six and seven to submit a symptom diary and answer a questionnaire about urinary symptoms. At the end of the study in week eight, they will have history and physical exams and blood draws. Some risks from the study may include side effects of torsemide like acute kidney injury, fluid/electrolyte loss, hypersensitivity reactions and reversible hearing loss/tinnitus.