Clinical Research Directory

Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)

Background: More than 6.5 million people in the United States live with heart failure (HF), and more than a million new cases are diagnosed each year. Treatments have improved in recent years, but researchers want to understand more about how HF develops. To do this, they need to compare blood and other samples from many people with HF. Objective: To collect blood and other samples from people with HF. These samples will be used to identify and study proteins and other factors that may lead to decreased heart function over time. Eligibility: People aged 18 years and older with heart failure. Design: Participants will be asked to join the study based on a review of their medical records. They will have 1 study visit. They will provide a blood sample: About 3 tablespoons will be collected from a needle inserted into a vein. Other tests are optional: Participants may provide urine and stool samples. They may have a cotton swab rubbed on the inside of the mouth to collect DNA. Participants may also take 3 questionnaires. They will answer questions about dietary, social, and other factors that affect their health. Participants will receive compensation. Researchers will follow the participants health by monitoring their medical records for up to 5 years.

CSP #2025 - Geriatric OUt-of-hospital Randomized MEal Trial in Heart Failure: Veterans Affairs (GOURMET-VA)

The purpose of this multi-center clinical trial is to study the efficacy and safety of providing nutritional support added to the study-defined standard of care which consists of standardized dietary education and a single dietary counseling session shortly after discharge, versus study-defined standard of care alone.

Staged Kidney Transplantation During Combined Heart/Kidney Transplantation

The primary purpose of this study is to evaluate the safety and efficacy of ex vivo machine perfusion with staged implantation of kidney allografts during combined heart/kidney transplantation.

Randomized Controlled Trial of urinE chemiStry Guided aCute heArt faiLure treATmEnt (ESCALATE)

This is a randomized trial of protocolized diuretic therapy guided by urinary sodium compared to structured usual care in ED patients with AHF. Participants will be recruited following an initial standard evaluation in the ED and randomized in a 1:1 fashion to structured usual care or protocolized diuretic therapy guided by urinary sodium.

A Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients With Heart Failure (CONFIRMATION-HF)

Combination therapy of finerenone plus empagliflozin will be compared to usual care to determine the efficacy and safety of treatment in patients hospitalized with heart failure.

Intrahospital Influenza Vaccination in Patients at High Cardiovascular Risk (VACC-UP)

The aim of this study is to evaluate the effect of offering intrahospital influenza vaccination as an adjunct to active counseling during the index hospitalization to adult patients hospitalized for acute coronary syndrome (ACS) or congestive heart failure (CHF), compared with active counseling alone, on influenza vaccination rates in patients at high cardiovascular risk. Patients are randomized 1:1 to either an offer of bedside intrahospital influenza vaccination according to the recommendations of the German Standing Vaccination Committee (STIKO) in addition to standardized active counseling (intervention group), or standardized active counseling plus the standard-of-care recommendation for ambulatory vaccination in the discharge papers (control group). The primary endpoint is the influenza vaccination rate at the end of the index season (March 31).

Improving How Older Adults at Risk for Cardiovascular Outcomes Are Selected for Care Coordination

This pragmatic clinical trial embedded in an accountable care organization will determine the comparative effectiveness of two approaches for assigning care coordinators to older adults at risk for cardiovascular outcomes. The hypothesis is that assigning care coordinators to older adults based on perceived need will be more effective at preventing emergency department visits and hospitalizations compared to usual care.

Novel Clinical Utility of Retinal Imaging in Patients With Heart Failure

Endothelial dysfunction and microvascular disease have been shown to play an important role in both the development and progression of heart failure. Retinal imaging provides a unique opportunity to non-invasively assess retinal microcirculation. Leveraging the non-invasiveness and relative ease of use of retinal imaging, we propose to investigate its clinical utility in assessing endothelial/microvascular dysfunction across the spectrum of heart failure. We aim to test the hypothesis that the degree of abnormality in retinal vessels is associated with heart failure disease severity, endothelial/microvascular dysfunction, and, potentially, treatment responses.

CGM Use in Heart Failure

Heart failure (HF) is a major cause of hospital admissions in the US, with over 6 million hospital days annually. More than 40% of hospitalized patients with HF have diabetes mellitus (DM), which increases the risk of recurrent hospitalizations for HF with reduced and preserved ejection fraction by more than two-fold. Current methods for assessing glycemic control do not consider fluctuations in blood glucose levels, known as glycemic variability. High glycemic variability is a poor prognostic marker for HF re-hospitalizations. Given the significant prevalence and impact of DM in individuals with HF, it is crucial to examine whether improving glycemic control and avoiding hypoglycemia could lead to a decrease in HF readmissions. Real-time continuous glucose monitoring (rt-CGM), which provides glucose measurements as frequently as every 5 minutes, has improved glycemic control in insulin-treated adults with DM compared to the standard of care, capillary point-of-care blood glucose testing (POC). Researchers will monitor participants during their hospital stay and 3 months after discharge.

Safety and Efficacy Study of AI Wall Thickness Measurement (EchoNet-LVH-RCT)

To determine whether an integrated AI decision support can save time and improve accuracy of assessment of echocardiograms, the investigators are conducting a blinded, randomized controlled study of AI guided measurements of wall thickness in parasternal long axis view compared to sonographer measurements in preliminary readings of echocardiograms.

The Fontan Dapagliflozin Pilot Study

The goal of this clinical trial is to study if an investigational study drug called Dapagliflozin could prevent heart failure from getting worse in adults with Fontan circulation. The main questions it aims to answer are: 1. Does Dapagliflozin decrease Fontan pressure? 2. Does Dapagliflozin improve exercise capacity and heart failure symptoms? Participants will have 4 study visits and 2 follow-up phone calls. The total duration of participation in the study will be up to 5 weeks from the time of screening to the completion of the final safety evaluation. Study procedures include the collection of study-related health information and blood samples, physical examination, exercise testing, total body water assessment, blood laboratory testing, health status survey, safety evaluation phone calls, and home blood pressure monitoring.

iCaReMe Global Registry: Multinational Real-world Evidence in Cardiorenal and Metabolic Diseases

To provide real world data on patient characteristics, disease management, healthcare utilization, and outcomes in patients with type 2 diabetes, Hypertension, Heart failure and/or Chronic kidney diseases

Barostim-Enabled NEurohormonal Intervention For Improving Treatment of Heart Failure

The purpose of BENEFIT-HF is to demonstrate the safety and effectiveness of Baroreflex Activation Therapy (BAT) with the Barostim System in participants with heart failure, defined as NYHA Functional Class II or III, LVEF \< 50% and NT-proBNP \< 5,000 pg/mL despite being treated with Guideline-Directed Medical Therapies (medications and devices). It includes demonstration that treatment with the Barostim System, relative to usual care medical management, reduces the rate of all-cause mortality and Heart Failure Morbidity (Cardiac Transplant, Durable LVAD, or Worsening Heart Failure Events).

A Trial to Evaluate the Safety and Efficacy of Pulmonary Artery Denervation for the Treatment of Pulmonary Hypertension Associated With Left Heart Failure

It's a phase III, prospective, multicenter, randomized controlled trial to evaluate the safety and efficacy of the pulmonary artery denervation (PADN) for heart failure (HF) patients diagnosed with pulmonary hypertension associate with left heart disease (PH-LHD) by right heart catheterization.

Mind Your Heart-II

This projects studies the role of mindfulness training (MT) to improve self-care among patients with heart failure and cognitive impairment.

Crome/Cobalt Respiration Study

The goal of this study is to compare measured respiration rates in various subject scenarios and use conditions between capnography and the Crome and Cobalt ICD and CRT-D MRI SureScan devices (derived using a Holter recorder).

Impact of Early Diagnosis and Treatment of OSA on Hospital Readmission in Hospitalized Cardiac Patients

The purpose of this study is to determine whether early diagnosis of obstructive sleep apnea and initiation of and adherence to CPAP therapy in hospitalized cardiac patients would impact 30-day hospital readmission rates.

Arterial Stiffness and Endothelial Function in Heart Failure

Heart Failure (HF) is a global condition affecting at least 26 million people worldwide. Despite advances in treatment, HF patients continue to experience poor health outcomes. This study aims to improve understanding of the role of blood vessels in people with heart failure. The study will assess how arterial stiffness (how stiff blood vessels are) and endothelial function (how well the lining of blood vessels functions) change over time and respond to treatments received as part of routine clinical care. Blood vessel function and heart performance will be assessed at three time points: * At baseline (when Patients are first diagnosed with heart failure). * After completing 4 ± 2 weeks of heart-failure medicines prescribed to patients as part of their routine clinical care. * After completion of cardiac rehabilitation program as a part of their routine clinical care. All assessments are non-invasive.

IRONICA: IRON Repletion In Heart Failure - A Comparison of Oral and IV Approaches

The goal of this clinical trial is to learn which iron treatment works better for adults with congestive heart failure and low iron levels: intravenous (IV) iron given through a vein or oral (PO) iron taken by mouth. Participants must have heart failure with reduced ejection fraction (HFrEF) or preserved ejection fraction (HFpEF) and a transferrin-saturation (TSAT) level below 20 percent. The main questions the study will answer are: 1. Does IV iron raise walking distance on a 6-minute walk test more than oral iron after 24 weeks? 2. Does IV iron improve symptoms and quality of life more than oral iron? 3. How do the two treatments compare for safety, side effects, and hospital readmissions/ mortality? Researchers will compare IV ferric carboxymaltose with oral ferrous sulfate to see which option helps people feel and function better. What participants will do * Be randomly assigned by (like flipping a coin) to IV iron or oral iron. * Receive either a one-time IV iron infusion (with possible repeat at 12 weeks) or take iron pills twice each day for 24 weeks. * Visit the infusion clinic at 6 weeks for second dose of IV iron if needed. * Visit the clinic at 12 weeks for a follow-up to gather follow-up data including 1. A 6-minute walk test 2. Brief symptom and quality-of-life surveys 3. Blood tests to measure serum iron, ferritin, and transferrin saturation This study will help doctors decide whether IV or oral iron is the safer, more effective way to treat iron deficiency in people with heart failure in our local community.

Determining Efficacy of an Artificial Intelligence-based System for Heart Failure Detection Through Interpretation of Electrocardiograms (DECISION)

The DECISION trial aims to evaluate the efficacy of an artificial intelligence (AI)-powered system, Willem™, for improving the detection of heart failure (HF) in primary care settings by interpreting electrocardiograms (ECGs). The study seeks to answer whether AI-assisted ECG interpretation enhances diagnostic accuracy and clinical outcomes compared to standard ECG evaluation in patients with suspected HF or those at high risk. This multicenter, pragmatic, randomized clinical trial involves two groups: patients receiving AI-assisted ECG analysis and those undergoing standard ECG evaluation. The study's primary analysis will compare the diagnostic performance of AI-assisted ECG versus standard ECG using sensitivity, specificity, and predictive value metrics. Secondary analyses will evaluate healthcare resource utilization, clinical outcomes, and usability feedback from healthcare providers. Results will inform the potential integration of AI-assisted ECG in routine primary care workflows for earlier HF detection and better resource allocation.

Virtual Nurse and Social Worker Palliative Care Team to Improve Quality of Life in Veterans With Heart Failure or COPD

Many Veterans living with heart failure or chronic obstructive pulmonary disease (COPD) experience significant symptoms - such as breathlessness, fatigue, depression, and anxiety -that reduce their quality of life. Despite how common these symptoms are, they are often not adequately addressed in routine care. This study tests whether a virtual team of a nurse and social worker can improve quality of life, depression, anxiety, and other patient-reported outcomes for Veterans with heart failure or COPD who are at high risk of hospitalization or death. The nurse helps Veterans manage their most bothersome symptoms using a structured approach, and the social worker provides brief counseling to address emotional and psychological concerns. Both work closely with the Veteran's primary care provider and palliative care clinician to coordinate additional care as needed. The study also examines whether enhanced implementation support helps VA sites adopt the program more successfully compared to standard implementation support.

Pharmacist-Assisted Titration of Rx to Implement Optimal Medical Therapy for Heart Failure

Many Veterans who are hospitalized with heart failure do not receive all the recommended heart medications at the right doses before they leave the hospital or in the weeks following discharge. This study tests whether a team of clinical pharmacists and cardiologists, working virtually, can improve heart failure medication prescribing for Veterans at VA medical centers. The pharmacist and cardiologist team reviews patient records and provides recommendations to the treating doctors and primary care providers caring for Veterans with heart failure. The goal is to increase use of guideline-recommended medications, which have been shown to improve survival, reduce hospitalizations, and improve quality of life.

Use of Point-of-Care Ultrasound (POCUS) to Reduce Hospital Length of Stay in Patients With Heart Failure ( POCUSHF )

This study will evaluate whether using bedside ultrasound (also called Point-of-Care Ultrasound or POCUS) can help improve the care of hospitalized patients with decompensated heart failure. Patients will be randomly assigned to two groups: one group will receive ultrasound-guided assessments, and the other group will receive standard clinical evaluations. Researchers will compare the hospital length of stay between the two groups. Ultrasound is a non-invasive, safe, and painless imaging tool. The goal of the study is to find out if ultrasound guidance can lead to shorter hospitalizations and better care for patients with heart failure.

Brain Volume and Cardiac Function in Heart Failure

Patients with heart failure (HF) exhibit greater structural brain alterations and higher dementia risks than the general population. Neural atrophy in nearly every region of medical limbic circuit has been observed in HF patients. Reduction of cerebral blood flow has been suggested as the pathophysiological pathway linking HF and structural brain changes. Indeed, lower cardiac index levels were related to lower cerebral blood flow in older adults without stroke, dementia, or heart failure. A few prior studies have examined the subcortical structural differences in patients with HF compared to controls. Brain volume loss (including putamen and hippocampal volumes) have been reported in patients with low ejection fraction. Significant gray matter loss was found in specific brain regions of HF patients and included structures that serve demonstrated roles in cognitive functions. In the investigator's previous study (Comprehensive Imaging Exam of Convalesced COVID-19 Patients - COVID-19 RELATED SUBMISSION-IRB00252436), involving 100 participants (volunteers with normal heart function (ejection fraction; 50%)), the investigators observed significant correlations between thalamic volumes and ventricular stroke volumes in volunteers. Building on these findings, the investigators intend to expand the research to include individuals with heart failure (HF), employing the same MRI protocol. The study will involve obtaining a set of T1-weighted brain images to measure the volumes of seven subcortical structures. The investigators goal is to explore the relationship between subcortical volumes and cardiac parameters. Additionally, the investigators will examine whether patients with HF experience a more rapid reduction in subcortical volumes compared to those with normal cardiac function (EF;50%).