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Showing 1-20 of 185 trials
NCT07096726
The purpose of this study is to analyze the utility of a novel five-point ultrasound as a predictor of volume overload in diverse patients who are admitted with volume overload/congestive heart failure (CHF) exacerbation at Boston Medical Center (BMC), the largest safety-net hospital in New England. Current standard of care (SOC) involves the utilization of laboratory markers and physical exam, which is often inconsistent and equivocal. The investigators will assess will assess if ultrasound-assisted diuresis reduces recurrent episodes of volume overload/decompensated heart failure.
NCT07400042
The purpose of the study is to determine if there is a reduction in the length of stay and rates of rehospitalization for patients diagnosed with congestive heart failure when physicians are provided daily measurements of peripheral venous pressure versus no daily measurements of peripheral venous pressure.
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.
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
NCT07440914
Exercise-based cardiac rehabilitation (CR) has been shown to significantly improve cardiovascular health and overall well-being in patients with congestive heart failure (CHF). However, a substantial number of CHF patients also suffer from comorbid conditions, such as knee osteoarthritis (OA), which can impede their ability to engage in physical activity and, consequently, derive full benefits from CR. Knee OA is characterized by pain, stiffness, and reduced joint mobility, which can significantly limit exercise capacity and adherence to CR programs. This dual burden poses a unique challenge, necessitating tailored rehabilitation approaches that accommodate both cardiovascular and musculoskeletal limitations. This study aims to evaluate the effectiveness of an exercise-based CR program specifically adapted for patients with CHF and coexisting knee OA, focusing on improvements in cardiovascular function, joint mobility, pain management, and overall quality of life. This study will employ a randomized controlled trial (RCT) design involving 100 patients diagnosed with both CHF and knee OA. Participants will be randomly assigned to either an intervention group or a control group. The intervention group will undergo a 12-week exercise-based CR program tailored to accommodate their knee OA, incorporating low-impact aerobic exercises, strength training, and flexibility exercises specifically designed to minimize knee joint stress. The control group will receive standard medical care without the structured exercise program. Primary outcomes will include changes in cardiovascular fitness, assessed by peak oxygen uptake (VO2 peak), and knee function, measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Secondary outcomes will assess pain levels, quality of life using the SF-36 questionnaire, and adherence rates to the rehabilitation program. Data will be collected at baseline, post-intervention (12 weeks), and at a 6-month follow-up to evaluate both immediate and long-term effects. Statistical analyses will be conducted to compare the outcomes between the two groups and determine the efficacy of the tailored CR program. Keywords: Exercised-based cardiac rehabilitation, Congestive heart failure, knee osteoarthritis, low impact aerobic exercise, strength training
NCT05507879
This study examines TRPC6 in predicting and preventing chemotherapy related cardiac toxicity and heart failure in patients with breast cancer. Cardiac toxicity, changes in heart function is a well-recognized complication of certain cancer related therapies. Understanding these changes may allow early intervention against therapy-related cardiac toxicity and also identify novel therapeutic targets to protect patient long-term cardiac health. Studying samples of blood from patients with breast cancer in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA), identify biomarkers related to cardiac toxicity, and prevent the development of therapy-induced cardiac toxicity in patients receiving chemotherapy.
NCT04551560
The purpose of this study is to investigate whether acute stress can precipitate congestive heart failure (CHF) exacerbation in patients with CHF.
NCT06904144
For patients discharged with a diagnosis of cardiovascular disease coronary artery disease resulting in myocardial infarction and/or congestive heart failure, this study will evaluate if the addition of 12 virtual health coaching sessions over the course of 16 weeks will improve physiological, psychological, and social health outcomes, prove acceptable and satisfactory for these patients with CVD, decrease CVD-related questions and concerns sent to the provider via MyChart, and reduce hospital readmission rates over a 90-day period as compared to patients discharged with the same diagnosis who receive standard post-discharge care. The study will also evaluate the perceptions of physician and advanced practice providers related to the health coach as part of the interprofessional team and the amount of time spent addressing CVD-related patient questions and concerns via MyChart messages.
NCT04100148
The SyncAV Post-Market Trial is a prospective, randomized, multi-center trial performed to determine if cardiac resynchronization therapy (CRT) devices programmed with SyncAV ON improve long-term CRT response compared to devices programmed with conventional CRT through evaluation of changes in left ventricular (LV) reverse remodeling.
NCT07284446
The goal of this observational study is to learn about the prevalence of depressive symptoms and cognitive impairment and their association with worse outcomes in a cohort of hospitalized patients between the ages of 18 ang 85 years with chronic heart failure. The main question it aims to answer is: • Does the presence of depressive symptoms and cognitive impairment lead to worse outcomes in a cohort of hospitalized patients with chronic heart failure? Participants who are hospitalized due to exacerbation of chronic heart failure will answer survey questions to assess their cognitive function and depressive symptoms.
NCT07013396
Endovascular therapy (EVT) has proven to be more beneficial for patients with AIS caused by large vessel occlusions (LVO) than medical management alone. A recent meta-analysis of 5 RCTs showed that EVT significantly reduced disability at 90 days compared to medical management \[1\]. Despite its obvious benefits, patients may have neurological deterioration despite successful thrombectomy due to ischemia progression, intracranial hemorrhage, re-occlusion, or vasogenic edema. The incidence of early neurological deterioration (END) following EVT for acute stroke has been reported to be ranging from 14.1-35.2% with some studies defining END up to 7 days and some restricting the definition between 6-72 hours post thrombectomy. A small proportion of these patients, approximately 5.9-10.5%, experienced sICH following EVT. Whether END occurs due to ischemic or hemorrhagic it leads to worse outcomes.
NCT02632656
The primary objective is to measure the association between extracellular RNA (ex-RNA) levels in plasma in patients receiving aggressive outpatient therapy for CHF with (1) cardiac remodeling and (2) cardiovascular events. The investigators will follow patients during standard medical therapy for CHF to assess changes in ex-RNA levels in the plasma, and how these are associated with cardiac remodeling (by cardiac imaging) and outcomes.
NCT07101289
The purpose of this parallel pragmatic randomized controlled trial (RCT) is to evaluate the impact of Eat Well (an evidence-based 'Food is Medicine' produce prescription program) with varying levels of behavioral support on health outcomes and care utilization patterns of Duke Health patients diagnosed with congestive heart failure (CHF). Objectives of this three arm trial include testing the effectiveness of Eat Well alone with minimal behavioral support and Eat Well with intensified behavioral support based on an evidence based approach to improve CHF patients' health outcomes, estimating health care cost savings between the intervention and control arms, and identifying barriers, facilitators, and potential strategies to enhance Eat Well effectiveness and implementation.
NCT04136951
This research work is focused on building and evaluating one of the first evidence-based clinical decision support tools for homecare in the United States. The results of this study have the potential to standardize and individualize nursing decision making using cutting-edge technology and to improve patient outcomes in the homecare setting.
NCT05574699
The overarching goal of this project is to leverage health information technology (HIT) to integrate available digital information on social needs to improve care for racial and ethnic minorities and socially disadvantaged populations with chronic diseases. In the previous phases of this project the investigators developed a social risk score to identify social needs among medically under-served patients with special emphasis on application among African American patients with low income and chronic diseases who face social determinants, risk factors, and needs (SDRN) challenges. The investigators also developed a clinical decision support (CDS) tool to present the social risk score to clinical providers and sought feedback from different users on the face and content validity of the CDS tool. In the current project the investigators will run a randomized clinical trial (RCT) study to pilot test the new risk score and CDS tool in selected primary care clinics at Johns Hopkins Health System (JHHS) and in collaboration with selected community-based organizations (CBOs). This system will help identify, manage, and refer patients with both high levels of disease burden and modifiable SDRN challenges.
NCT06139653
Heart failure (HF) is a systemic clinical syndrome defined as cardiac dysfunction, which causes inadequate blood supply to meet metabolic needs. One of the most expressive markers of HF is neurologic exacerbation, with expected sympathetic hyperactivation, increased activity of the renin-angiotensin-aldosterone system and elevation of vasopressin levels. These changes compensate the low cardiac output in the onset of ventricular dysfunction ensure a long term high blood perfusion pressure,though aggravate this dysfunction and contributes to the HF progression. There are evidences ofthe therapeutic effects of respiratory exercise techniques for HF patients. However, it demands new data for larger prescription and employment of these kind of exercises. Advanced technologies allowed the elaboration of the application for slow breathing CardioBreath. So far, it requires the possibility of comparison of their effects versus widely validated Inspiratory Muscle Trainig (IMT) on respiratory and cardiovascular outcomes in order to elucidate their specific benefits. In this way compare CardioBreath ® App versus IMT through a crossover randomized clinical trial design may elucidate the response effects of these interventions in these patients.
NCT07091435
The study is planned to be completed over three years and will focus on 500 hospitalized older adults with a diagnosis of CHF. The Biopsychosocial model will be used to conduct this study. Phase 1: This phase aims to determine the incidence rates of sarcopenia, frailty/social frailty among hospitalized older adults, and to compare these outcomes in gender differences. Sarcopenia will be identified according to the AWGS guidelines, while clinical characteristics, including ejection fraction, stage of CHF, and comorbidities, will be collected via chart review using the 2024 Guidelines of the Taiwan Society of Cardiology(Y. H. Li et al., 2024). Frailty and social frailty will be measured using the CFS, Tilburg Frailty Indicator (TFI), and Makizako's Social Frailty Questionnaire, respectively, and physical activity levels will be assessed with the International Physical Activity Questionnaire - Short Form (IPAQ-S). To develop a predictive model examining risk factors for social frailty and health outcomes, with a focus on gender differences, we will employ Structural Equation Modeling (SEM). SEM allows for the analysis of complex relationships among variables, facilitating a comprehensive understanding of how these factors interact differently across genders. Phase 2: A quasi-experimental design will be implemented, involving 174 hospitalized older adults with low social frailty scores. Participants will be randomly assigned to one of three groups. Group 1 will use the ChatGPT app for 15-30 minutes daily, with the app actively monitoring their emotional status and automatically notifying the research team and family members if signs of negative mood are detected. Group 2 will be encouraged to increase their social participation through community-based activities. The Control Group will continue their routine lifestyle without additional interventions. Before the intervention, one-on-one training will be provided to Group 1 participants on how to use ChatGPT. Key outcome measures, including mood status (loneliness, anxiety, and depression), physical activity (assessed via IPAQ-S), overall frailty (CFS \& TFI), social frailty scores, and other health indicators, will be assessed at baseline and immediately post-intervention. Phase 3: The aim of this phase is to monitor and compare the longitudinal health outcomes of interventions among the three groups. Key health outcomes will be assessed and compared every three months over a one-year period.
NCT00762333
The purpose of this research is to determine if two proteins in the blood are increased during acute myocardial infarction and whether their levels are higher in those who develop heart failure than those who do not. These two proteins are produced and potentially released when the heart muscle is damaged. They may then be released into the blood and be detected by standard method in the research laboratory. At this time, detection of an increase in these proteins in the blood is not known to be associated with any disease or myocardial infarction.
NCT03994874
Randomized, controlled, unblinded, adaptive design clinical trial to evaluate the safety and efficacy of PolyCore (Polydextrin, L-Carnitine, D-xylitol) peritoneal ultrafiltration (PUF) in patients with heart failure and reduced ejection fraction (HFrEF).
NCT04179643
This is a Phase 1, prospective, multi-center, open-label, sequential dose escalation study to explore the safety, feasibility, and efficacy of a single intracoronary infusion of AB-1002 in patients with NYHA Class III heart failure. Patients with non-ischemic cardiomyopathy will be enrolled until up to 17 subjects have received infusions of investigational product. All patients will be followed until 12 months post treatment intervention, and then undergo long-term follow-up via semi-structured telephone questionnaires every 6 months for an additional 24 months (+/- 30 days).