Active clinical trials for "Heart Failure"

This research study will compare two standard of care approaches for managing low sodium levels in heart failure patients with Left Ventricular Assist Device (LVAD). The study will compare the outcomes of LVAD patients with low sodium levels who take Tolvaptan to those who do not take Tolvaptan. Tolvaptan is FDA approved for use in the study population and is commonly used to treat low sodium levels in heart failure and LVAD patients. It is not known if taking Tolvaptan or not taking Tolvaptan is better at improving outcomes in newly implanted LVAD patients with low sodium levels. By doing this study, the Principal Investigator (PI) hopes to learn which is better at improving outcomes.

This is a feasibility study using a cross-over design to implement and compare a best practice alert (BPA) with an automated in-basket message to inform providers when a patient with heart failure and reduced ejection fraction (HFrEF) is not on appropriate medical therapy. The data from this pilot study will lead to a randomized controlled trial to compare the effectiveness of the BPA versus an automated in-basket message, versus usual care (no intervention).

Heart failure from myocardial iron deposition is a severe complication for patients with hematological disorders who need repeated blood transfusions. Increased cardiac iron content impacts the contractility of cardiomyocytes and can also lead to myocarditis, pericarditis, and arrhythmias. The severity of cardiac dysfunction depends on the amount of iron deposited in the myocardium. Cardiovascular magnetic resonance (CMR) imaging is used as noninvasive method to evaluate the amount of iron in the heart. Myocardial T2* value has been shown to correlate well with biopsy-derived iron concentration in the heart, and myocardial T2* values less than 20ms (indicating elevated iron) were found to be associated with LV dysfunction and improve in concert with LV function during recovery. The majority of the recent studies about myocardial iron overload and the effect of iron chelation therapy were focused on patients with transfusion-dependent hematological disorder, especially beta-thalassemia major. The objective of this 3-year project is to evaluate myocardial iron deposition in patients with heart failure, induced by variable causes. With myocardial T2* imaging, the investigators will analyze the decreased signal intensity in the ventricular septum and quantitatively acquire the T2* value as marker for myocardial iron deposition. The first year is a cross-sectional study. The investigators aim to compare the severity of myocardial iron deposition of normal subjects and that of stable HF patients in recovery with normal or impaired ejection fraction (EF). Total 60 subjects will be enrolled, with 20 subjects in each group. In the 2nd and 3rd years, the investigators plan a prospective longitudinal study of 40 subjects. Enrolled patients will be evaluated with cardiac T2* imaging at three time points, i.e., disease onset, 6 months and one year after treatment, and will be followed up until the end of this project (1.5~3-year follow up). In total 120 MR scans will be performed in the 2nd and 3rd years. The presence and severity of myocardial iron deposition will be correlated with the disease course, patient biochemistry data and clinical outcome.

Summary Chronic heart failure continues to be one of the highest economic burdens in the United States, heavily influenced by frequent readmissions to the hospital. This study will examine whether patients 65 years and older, who have NYHA class II and III heart failure, will improve their symptoms after participating in a comprehensive 12-week lifestyle change program. The investigators will recruit potential subjects primarily from the Scripps Clinic heart failure clinic at the Torrey Pines campus. Qualifying subjects will be randomized to medical treatment as usual or the lifestyle program. The investigators will enroll 17 subjects into each group which will provide 80% power and an alpha of 0.05. The lifestyle change program consists of classes conducted three times a week for 12 weeks at the Scripps Center for Integrative Medicine. Each day participants will spend about four to five hours in a variety of classes such as monitored exercise, group support, mindful-yoga and meditation, vegetarian cooking classes, music-centered wellness, mind-body lectures, and resiliency training. The primary outcomes will focus on determining functional status and physical agility using the 6-minute walk test, handgrip strength, and NYHA class categories. In addition, the investigators will capture subjective physical status with a self-reported questionnaire. Cognitive assessment will be performed using the Montreal Cognitive Assessment tool. To capture the subject's overall self-reported improvement the investigators will use a quality of life and a depression questionnaire. Secondary endpoints include hospital admission rates and all-cause mortality.

The study aims 1) to determine autoantibody titers against the AGTR1 receptor and against the ETA receptor, 2) to characterize cytokine expression profiles of heart-specific activated T cells in patients with systolic heart failure. Auto-antibody titers and specific cytokine expression profiles in heart-specific activated T cells will then be correlated with heart failure progression and outcome.

PRIMARY OBJECTIVE To establish the effect of metal ion release from metal hip implants on cardiac function STUDY OUTCOME MEASURES To assess the effect of metal ions from hip implants on cardiac function as measured by Cardiac Magnetic Resonance Imaging (CMR) and Echocardiogram. This involves the surrogate detection of cobalt ion deposition within cardiac tissues and assessment of ejection fraction and tissue characterization (with and without contrast). STUDY IMPACT With 60,000 patients having a metal on metal (MOM) hip implant in the United Kingdom (UK), and over a million worldwide, there is need to clarify this important question, which is the source of significant concern amongst patients and surgeons alike. Also, this problem is not unique to MOM hips since all hip implants contain metal and as seen in various case reports high blood cobalt levels have arisen after catastrophic failure (e.g. fracture of a ceramic bearing surface) leading to abnormal wear of the implant and release of metal ions into the body. In the UK, over 80,000 hip implants are inserted annually.

In chronic systolic heart failure patients submitted to cardiac resynchronization therapy, the study aims at assessing whether geometric variations in coronary sinus lead tip trajectory throughout the cardiac cycle acutely induced by biventricular pacing, are predictive of the volumetric and clinical response to the treatment at six-month follow-up.

Aims: Advance care planning (ACP) is considered to be one of the most promising interventions to enable patients with life limiting illnesses to receive treatment at the end of life (EOL) according to their own preferences and to promote EOL conversations between patients and their health care providers. Through a 2-arm randomized controlled trial (RCT) of patients with Class III and IV heart failure (New York Heart Association Functional Classification), we propose to assess: Whether patients in the ACP arm have a greater likelihood of receiving EOL care consistent with their preferences as stated in the latter of the last ACP document or the last patient interview, compared to patients in the control arm. Heath care costs during study duration between patients in ACP and control arms. Patient's understanding of own illness and their participation in decision making between the ACP and control arms. Patient's quality of life, anxiety and depression between ACP and control arms. Methodology: A total of 254 patients with advance heart failure will be randomized to receive intervention (ACP arm; N=127) or usual care (control arm; N=127). The RCT will be conducted at the National Heart Centre and Singapore General Hospital. Patients in both arms will be followed for one year or till death, whichever is earlier, and interviewed every 4 months during this duration. Clinical Significance: If benefits of ACP are shown to add value through this trial, then this study will help to promote acceptance of ACP among patients and health care providers across Singapore and elsewhere.

This study is assessing the effects of a new heart failure self-care education program in the Nebraska Heart Institute Heart Improvement Clinic. The new education program will consist of an initial intensive self-care education session with the Principal Investigator or her nurse practitioner. Topics to be discussed include medications, sodium and fluid consumption, alcohol restriction, exercise, preventive behaviors, and monitoring of signs and symptoms. As recommended in the ACCF/AHA guidelines, this education will be repeated on an annual basis as studies have shown that the impact of HF education is not always durable and must be a continual process. This study will assess the impact of this review on their medication knowledge, disease state knowledge, quality of life, disease state progression and clinical outcomes such as ejection fraction and number of hospitalizations.

This is a study to find out whether cardiac rehabilitation is feasible in Western Kenya. This study will test whether cardiac rehabilitation is feasible by measuring how many participants are able to follow and complete two different exercise protocols; one at home and one in hospital. It will also measure how the exercise intervention affects quality of living, depression and improvement in exercise tolerance.