Active clinical trials for "Heart Failure"

Heart failure is the most rapidly rising cardiovascular disease and has come to be recognized as a growing epidemic. Digital health interventions are the most recent iteration of an effort to promote individualized outpatient care through positive behaviour change theory. The UHN team has developed a highly automated and user-centered smartphone-based system, Medly, which allows for the telemonitoring of patients diagnosed with heart failure. The purpose of this study will be two-fold: 1) to determine if the introduction of Medly within two weeks of discharge will improve self-care management, quality of life, and clinical status, 2) to assess whether Medly will lead to a potential reduction in 30 day readmission rates amongst HF patients in the Toronto Central Local Health Integration Network (TC LHIN), without increasing the average length of stay or visits to the emergency department. These parameters will be measured as secondary outcomes.

This pilot study will evaluate the efficacy and safety of CCM therapy in heart failure patients with baseline EF≥50% (HFpEF) who have New York Heart Association (NYHA) Class II or III symptoms despite appropriate medication. The terminology of the HF classification HFpEF is based on the 2016 European Society of Cardiology (ESC) Heart Failure Guidelines.

The study is a randomized controlled trial to estimate the effects of the transitional care model (TCM) on hospital admissions and patients' experience during the year following the patient's qualifying discharge. The University of Pennsylvania, where TCM was developed, will be the coordinating center for the implementation. The study will be conducted in three large health systems spread throughout the U.S., drawing patients from seven hospitals in those systems. Eligible patients are older adults (age 65 and older) admitted to a participating hospital with symptoms of heart failure (HF), chronic obstructive pulmonary disease (COPD), or pneumonia (PNA). The evaluation will be conducted by Mathematica.

INTRODUCTION Psychological distress and reduced quality of life are prevalent within the heart failure (HF) population. The 1-year rehospitalization (40%) and 5-year mortality (45% for women and 60% for men) rates are high. International task force committees report that medical therapy combined with counselling for HF self-care optimizes clinical outcomes. HYPOTHESES At trial completion (median = 8.5 months, range = 2 to 15 months), ODYSSEE-vCHAT versus enhanced usual care (eUC) is predicted to reduce morbidity and mortality rates. Greater engagement with the digital program is also predicted to be linked with improved self-reported mental and physical health at months 4, 8, and 12 and trial completion. RECRUITMENT HF patients who are at least 18 years old were recruited from the University Health Network (UHN), Sunnybrook Hospital, Mount Sinai Hospital, and the community. Accrual of the sample (N = 61) occurred over 13 months. DESIGN ODYSSEE-vCHAT is a double-arm, parallel-group, randomized, controlled (real-world) pilot trial with assessments at baseline, months 4, 8, and 12, and trial completion (median = 8.5 months, range = 2 to 15 months). It is a single-blind trial, with research personnel blinded (excluding the research coordinator). All patients were provided with free access to their respective digital intervention, ODYSSEE-vCHAT or eUC. Subjects were invited by weekly emails to participate in the resources available to their group. eUC patients were provided with access to educational materials for HF self-care that are available to the public on professional heart health websites. Participation in supplementary programs that provide HF self-care education was not restricted, rather it was monitored by self-report during assessments and will be statistically controlled for during outcome assessments. ANALYSIS Separate generalized linear models (GLMs) will evaluate ODYSSEE-vCHAT versus eUC for primary and secondary outcomes. GLMs will be adjusted for baseline assessments and potential covariates. Interactions between treatment arm and gender will be examined for each outcome, using Bonferroni post-hoc comparisons for relevant subgroups. Significance in all tests will be p < 0.05, 2-sided.

Acute heart failure current management turns out to be a relative failure considering its elevated economical and human costs and the poor results obtained in terms of disease outcome. Indeed this disease remains associated with a high rate of early re-hospitalizations and low adherence to therapeutic recommended settings and doses. Moreover, extra cardiological follow-up such as in social, geriatric or vaccination fields remain low compared to real needs. Current recommendations incite health professionals to better define care pathways and to rationalize resources. Guidelines toward creation of hospitalization alternatives or limitation of time spent in hospital are given. In the same time, lack of cardiologic care management within heart failure patient care pathway is associated to poor prognosis and medical desertification as well as resource concentration on important health centers exacerbate this phenomenon. Innovative projects are then needed to improve patient care pathways, to open up areas without specialized health professionals and to rationalize care management by encouraging communication and skill exchange between hospitals and private practices. FIL-EAS ic projet aims to compare a conventional care pathway in hospital with a follow up defined according to High Authority of Health recommendations to an organized care pathway favoring a short hospitalization (maximum of 4 working days) with early transition, when possible, to a medical and paramedical home care management with an approximately 10 day long combined follow up between hospital and private practices. This second care pathway should help to optimize therapeutics in home living conditions.

Some patients living with multiple long-term health conditions have difficulty accessing the services they need, despite available primary care and community resources. Patient navigation programs may help those with complex health conditions to improve their care and outcomes. Community health navigators (CHNs) are community members who help guide patients through the health care system. CHNs are not health professionals like a doctor or nurse, but they are specially trained to help patients get the most out of their health care and connect them to resources. The ENCOMPASS program of research evaluates a patient navigation program that connects patients living with long-term health conditions to CHNs. To understand if the CHN program can be scaled to a provincial level, the ENCOMPASS program of research is expanding to select primary care settings across Alberta. This study implements and evaluates the CHN program at Edmonton Oliver Primary Care Network in Edmonton, Alberta, Canada.

Heart failure (HF) patients with supportive caregivers have better physical health, emotional health, and quality of life. But caregivers have an increased risk of caregivers' own worsening health and often feel a sense of burden related to caregiving. However, caregivers receive very little support to balance caring for the patient with caring for themselves. Therefore, this research will provide a program for caregivers of advanced heart failure patients to build on the caregiver's strengths, sense of purpose, and set goals for healthy lifestyle changes. The investigators believe that caregivers who receive the program will have better quality of life, less sense of burden, and a healthier lifestyle.

Feasibility and safety study of the alfapump DSR system in the treatment of volume overloaded heart failure subjects receiving high doses of loop diuretics. Up to 24 subjects will be enrolled in up to 3 centres in Republic of Georgia, and randomized into 2 parallel treatment arms. Once implanted with the alfapump DSR system they will undergo DSR therapy in 2 phases: intensive treatment phase followed by maintenance treatment phase.

In this study, the investigators are testing the hypothesis that reduction in sympathetic activity would be greater following high-intensity interval training (HIIT) than moderate-intensity continuous training (MICT) and correspond with improvements in peripheral vascular function, and skeletal muscle function in patients with heart failure with reduced ejection fraction (HFrEF).

This Stage II randomized, controlled, longitudinal trial seeks to assess the acceptability, feasibility, and effects of a driving decision aid use among geriatric patients and providers. This multi-site trial will (1) test the driving decision aid (DDA) in improving decision making and quality (knowledge, decision conflict, values concordance and behavior intent); and (2) determine its effects on specific subpopulations of older drivers (stratified for cognitive function, decisional capacity, and attitudinally readiness for a mobility transition). The overarching hypotheses are that the DDA will help older adults make high-quality decisions, which will mitigate the negative psychosocial impacts of driving reduction, and that optimal DDA use will target certain populations and settings.