Clinical Research Directory

Palliative Care for People With HF

Imagine having heart failure, a condition where the heart struggles to pump blood, making daily life hard. People with heart failure often don't feel well and end up going to the hospital a lot. Many of these people could feel better with extra help, but there aren't many programs that offer support beyond usual heart failure treatments. That's where the ADAPT program comes in, which stands for "Advancing Symptom Alleviation with Palliative Treatment." In this program, nurses and social workers call people weekly, helping them manage their toughest symptoms, offering tools to cope with heart failure, and keeping the patients' current doctors involved. We tested this program in a research study with heart failure patients and found that it improved their quality of life and lowered depression, anxiety, and heart failure symptoms. The question now is if the ADAPT program will work in the community, outside of a research setting, so that more people could benefit from it. Specifically, can the ADAPT program work well in new places? Will patients and their families find it helpful? Most importantly, can it help improve the lives of people with heart failure in these new settings? To answer these questions, the study team will work with healthcare providers to 1) ask how to adjust the ADAPT program to work well in various settings (e.g. primary care, heart failure clinic) and 2) use this information to create simple materials and trainings to help them easily provide ADAPT. This will prepare for the next phase of this project to test out the new ADAPT program.

AI-Based Monitoring System for Chronic Heart Failure With Advanced Wearable and Mini-Invasive Devices

The goal of this observational, multicenter study is to evaluate whether AI-driven remote monitoring using a mini-invasive wearable device can improve clinical outcomes in adult patients (≥18 years) with chronic heart failure (CHF). The main questions it aims to answer are: * Can continuous remote monitoring reduce hospital admissions (emergency visits and hospitalizations) by 20% compared to standard care? * Does wearable-based remote monitoring improve functional, biochemical, and instrumental parameters in CHF patients? Researchers will compare patients using the wearable device (intervention group) to those receiving standard clinical follow-up (control group) to assess whether AI-driven monitoring leads to fewer hospitalizations, better disease management, and improved quality of life. Participants will: * Wear the EmbracePlus (Empatica Inc.) device continuously for six months (intervention group only). * Have their biometric data (SpO₂, HRV, EDA, respiratory rate, temperature, sleep quality) monitored remotely. * Receive automated alerts and teleconsultations if abnormal physiological changes are detected. * Attend scheduled follow-up visits (remote and in-person) for clinical evaluation and treatment adjustments. The study aims to provide real-world evidence on whether integrating wearable health technology with AI analytics can enhance CHF management and improve patient outcomes.

Evaluation of the HeartLogic Diagnostic in Optimizing Guideline-directed Medical Therapy in Patients With Congestive Heart Failure and Chronically Low Ejection Fractions (EFs)

The goal of this trial is to determine if the addition of the Heart Logic diagnostic alerts to standard of care therapies will lessen hospitalizations and improve quality of life in patients with heart failure.

Health Coaching for Patients With Cardiovascular Disease

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.

Multicenter Study on Cardiovascular and Metabolic Complications in Patients With Biochemically Silent Pheochromocytomas and Paragangliomas

The aim of the study is to characterise the cardiovascular and metabolic complications pre- and post-surgery of patients with biochemically negative PPGL and to compare them with normal individuals and patients with secreting PPGLs age and sex matched.

Depressive Symptoms, Cognitive Impairment, and Outcomes in Hospitalized Chronic Heart Failure Patients

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.

Eat Well Heart Failure

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.

Protective Effect of EECP Against Negative Inflammatory Response and Organ Dysfunction After Cardiovascular Surgery

Enhanced external counterpulsation (EECP) is a noninvasive, non-pharmacologic intervention proven to increase nitric oxide bioavailability in patients with coronary artery disease. Although EECP showed short-term effects in improving coronary flow in patients with coronary slow flow, whether such improvement is durable remains uncertain, and the relationships between such improvement and changes in multiple organ functions as well as inflammatory markers have not been elucidated. The purpose of this study will be to evaluate the potential clinical benefits of EECP on organ function and proinflammatory cytokine concentrations during post-acute sequela of cardiovascular surgery.