Clinical Research Directory

PAtient Similarity for Decision-Making in Prevention of Cardiovascular Toxicity (PACT): A Feasibility Study

This is a single-center, double-arm, open-label, randomized feasibility study that will determine whether a novel clinical decision aid accessed via the electronic health record will be acceptable to both cancer survivors and their cardiologists, will favorably impact appropriate medication use and cardiac imaging surveillance, and will improve clinician and patient decision-making, perception, and behavior towards cardioprotective medication usage and cardiovascular disease imaging utilization.

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.

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).

31P-MRS Myocardial Energetic Phenotyping and Prognosis Across the Cardiac Disease Spectrum

The study is designed to establish a comprehensive myocardial energetic phenotype across a broad spectrum of cardiovascular diseases using phosphorus-31 magnetic resonance spectroscopy (31P-MRS). And the study plans to enroll 1,000 participants, comprising healthy volunteers and patients with diverse cardiac conditions. Target cohorts primarily encompass heart failure syndromes and various cardiomyopathies, with a particular focus on non-ischemic and hypertrophic phenotypes, as well as ischemic and other structural etiologies. By integrating 31-MRS with multiparametric standard CMR, this study aims to map disease-specific metabolic signatures. The primary outcome measure is the myocardial PCr/ATP ratio, serving as a direct in vivo marker of energetic impairment. Furthermore, the study aims to explore the coupling between metabolic phenotypes and structural remodeling (tissue characterization), mechanical dysfunction, and systemic clinical biomarkers. Crucially, the study will evaluate the prognostic value of these energetic phenotypes in predicting clinical outcomes, ultimately providing novel insights into the pathophysiology and risk stratification of cardiomyopathies and heart failure.

Impact of a Tailored Digital Intervention on Sedentary Behaviour and Physical Health in Long-term Cardiac Rehabilitation Patients

Sedentary behaviour (SB) is an independent cardiovascular risk factor that remains highly prevalent among individuals attending long-term cardiac rehabilitation (CR) programs, despite participation in regular supervised exercise. Although CR provides an ideal setting for promoting healthy lifestyle behaviours, evidence on tailored interventions specifically targeting SB in long-term CR programs remains limited. This randomized controlled trial aims to evaluate the effectiveness of a 6-month tailored behavioural intervention, supported by digital health tools, in reducing SB among adults attending a long-term phase CR program. Participants will be randomly allocated to either an intervention group (IG), receiving standard CR plus individualized behavioural counselling, digital prompts, and educational resources, or a standard care group (SCG) receiving usual CR and educational resources only. The primary outcome is objectively measured daily sedentary time assessed using activPAL4 (h/day). Secondary outcomes include objectively measured physical activity (PA), body composition, cardiorespiratory fitness, muscular strength, health-related quality of life and other behavioural outcomes. Outcomes will be assessed at baseline, 3, 6, and 12 months, according to the specific assessment schedule. The study aims to determine whether integrating a tailored behavioural intervention into routine long-term CR leads to sustained improvements in SB and related health outcomes.

Donor Bone Marrow Derived Mesenchymal Stem Cells in Controlling Heart Failure in Patients With Cardiomyopathy Caused by Anthracyclines

This randomized pilot phase I trial studies the side effects of donor bone marrow derived mesenchymal stem cells in controlling heart failure in patients with cardiomyopathy caused by anthracyclines. Donor bone marrow derived mesenchymal stem cells may help to control symptoms of heart failure and improve heart function.

SWitching to Appropriate Prescription in Cardiovascular-Kidney-Metabolic Syndrome

SWAP-CKM (SWitching to Appropriate Prescription in Cardiovascular-Kidney-Metabolic Syndrome) is a pragmatic, cluster-randomized clinical trial designed to evaluate whether electronic health record (EHR)-based alerts can improve medication prescribing among adults with cardiovascular, kidney, and metabolic (CKM) conditions. The study will include all eligible adult patients receiving care within Kaiser Permanente Northern California (KPNC) who have CKM conditions and opportunities for therapeutic medication substitution. Fifteen service areas are randomly assigned to either an intervention group or a usual care group. Clinicians in the intervention group will receive EHR-based Best Practice Advisories (BPAs) identifying opportunities to replace potentially inappropriate medications with guideline-recommended therapies. The intervention may also include audit-and-feedback reports to support medication optimization. Clinicians retain full discretion over treatment decisions. The primary outcome is the proportion of eligible therapeutic optimization opportunities achieved at 9 months. Secondary outcomes include medication initiation and discontinuation, medication optimization at 18 months, and polypharmacy burden.

Notification Of High-Risk Veterans for Access to Heart Failure Prevention

The purpose of this study is to learn whether connecting people at high risk for developing heart failure to a heart doctor (cardiologist) leads to greater use of treatments that can lower that risk. Heart failure is a condition in which the heart cannot pump blood as well as it should. The study focuses on Veterans living in rural areas, who often have a higher risk of heart failure and less access to heart care. The study team will use health record information to find Veterans who are at high risk for heart failure but do not yet have it, and who have health factors that could be improved with preventive treatment. The study team expects that telling these Veterans and their primary care providers about the elevated risk, and offering early cardiology care, will lead to greater use of treatments known to help prevent heart failure compared with usual care. The main questions the study aims to answer are: * Does informing a Veteran and their primary care provider about the Veteran's elevated risk for heart failure, and offering a referral to a cardiologist, increase the use of treatments known to help prevent heart failure? * Does having a care navigator reach out to Veterans and their primary care providers further help connect these Veterans to preventive care? Veterans in the study will be placed by chance into one of three groups. One group will receive usual care. A second group, along with their primary care provider, will be told about the Veteran's elevated risk for heart failure and offered a referral to a cardiologist. A third group will receive that same information and referral offer, plus outreach from a care navigator who can explain more about heart failure and the reason for the referral, answer questions, and help with scheduling.

Supporting Health in Veterans With Heart Failure

This study will test the effectiveness of a culturally-sensitive, telephone-based, tailored problem-solving intervention to improve physical and mental health in Veterans with heart failure (HF). Veterans will be recruited from VA clinics throughout the United States. As a component of this study, Veterans will partner with a registered nurse for a 12-week telehealth program that includes 8 telephone sessions. Follow-up data will be collected at 3-months (post intervention) and 6-, 12-, and 18-months to examine sustainability of intervention effect.

AI-Based Cardiac Analysis Using 12-Lead and 1-Lead ECG

This pilot study is designed to evaluate the clinical performance and utility of the SmartECG-EF software in patients undergoing evaluations at Inha University Hospital. The primary objective is to assess how effectively the device assists clinicians in evaluating cardiac function and related clinical parameters. The study will prospectively enroll eligible participants to gather real-world clinical data, contributing to enhanced diagnostic accuracy and patient management.

Real-world Effectiveness and Safety of Savagen (Sacubitril/Valsartan) in Malaysian HFrEF Patients

This multicentre, prospective, single-arm cohort study will evaluate the real-world effectiveness and safety of Savagen, an NPRA-approved generic sacubitril/valsartan, in Malaysian adults aged 18 to 70 years with heart failure with reduced ejection fraction (HFrEF; LVEF ≤40%, NYHA class II-III). Approximately 80 patients initiating Savagen as part of routine clinical care at hospitals offering a Heart Failure Medication Therapy Adherence Clinic (HFMTAC) will be followed for 12 months. The primary outcome is the change in NT-proBNP from baseline to 12 months. Secondary outcomes include changes in LVEF, renal function (serum creatinine, eGFR), serum potassium, patient-reported health status (KCCQ) and dietary diversity (Dietary Diversity Score), a composite of cardiovascular death or first heart failure hospitalisation, and adverse events, including hypotension, hyperkalaemia, renal impairment and angioedema. The study does not aim to establish equivalence with the reference product; it will generate local real-world evidence on the effectiveness, tolerability, safety and patient-reported outcomes of generic sacubitril/valsartan in routine Malaysian HFrEF care.

Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)

This study aims to compare the efficacy of vericiguat versus placebo on change in n-terminal pro-brain natriuretic peptide (NTproBNP) from baseline to Week 16 of the Base Period. The primary hypothesis is that vericiguat is superior to placebo in reducing NT-proBNP at Week 16 of the Base Period.

Study for Evaluation of Safety and Efficacy of PADN to Treat Combined Post- and Pre- Capillary Pulmonary Hypertension Associated With Chronic Heart Failure（PADN-CpcPH-PILOT）

The goal of this pilot study is to evaluate the safety and efficacy of pulmonary artery denervation (PADN) in Combined Post- and Pre- Capillary Pulmonary Hypertension Associated with Chronic Heart Failure. Participants who have received guideline-directed medical therapy (GDMT) according to 2022 AHA/ACC Guidelines for Heart Failure (HF) and have been clinically stable for at least 1 month, will be treated with PADN and followed for 1 year.

Metabolic Changes in Heart Failure Patients Treated With Vericiguat

Heart failure is a condition in which the heart cannot pump blood as effectively as it should. It can cause symptoms such as shortness of breath, tiredness, and fluid retention. Vericiguat is a medication used in certain patients with heart failure whose symptoms have recently worsened. The aim of this study is to better understand how vericiguat treatment is associated with changes in metabolism, heart function, and blood vessel health in patients with heart failure. This is a prospective, observational study conducted at a single hospital in Italy. Researchers will collect clinical information and analyze biological samples to investigate changes in molecules involved in energy production, inflammation, and cardiovascular function. Heart imaging and assessments of blood vessel function will also be used to better understand the patients' cardiovascular health. The study will explore whether these biological and cardiovascular measurements are associated with treatment with vericiguat and whether they could help identify patients who may benefit most from this therapy. The results may improve our understanding of heart failure and support more personalized treatment strategies in the future.

Danish Pragmatic Randomized Trial to Evaluate the Effect of HeartLogic-Guided Management on Heart Failure Outcomes

The purpose of the study is to assess the impact of HeartLogic-guided management on clinical outcomes among patients implanted with an eligible cardiac device.

Bedside Ultrasound in the Emergency Department for Predicting Acute Heart Failure Outcomes

Acute heart failure is a common and serious condition that frequently brings patients to the emergency department. Emergency physicians need quick and reliable methods to evaluate the severity of the condition and monitor the response to initial treatment. This observational study aims to evaluate the effectiveness of bedside ultrasound (Point-of-Care Ultrasound or POCUS) in predicting clinical outcomes for these patients. Researchers will perform bedside ultrasound scans on adult patients presenting with acute heart failure. The scans will be performed twice: first upon admission to the emergency department, and again three hours after starting treatment. The ultrasound protocol will check the heart's pumping ability, look for fluid in the lungs, and measure specific veins (inferior vena cava and internal jugular vein) to assess fluid overload. The main goal of this study is to see if these ultrasound measurements can successfully predict important patient outcomes, including the likelihood of returning to the hospital within 30 days and 30-day survival.

Evaluation of the Effects of Sauna Therapy on Congestion and Loop Diuretic Use in Patients With Heart Failure With Reduced or Moderately Reduced Ejection Fraction

This study aims to evaluate the effect of sauna therapy on congestion levels during cardiac rehabilitation in patients with heart failure who have an impaired or moderately impaired ejection fraction, compared to standard cardiac rehabilitation care. To investigate this, patients with reduced cardiac function who are hospitalized as part of a cardiac rehabilitation program will be included. These patients will be randomly assigned to two groups: standard cardiac rehabilitation program (control group) and sauna group (intervention group). The study will also assess whether this approach could allow for a reduction in the dose of diuretics, which are commonly used to remove excess fluid, thereby helping to avoid certain side effects. The expected benefits include a reduction in symptoms such as shortness of breath and swelling, improvements in quality of life and physical fitness, and enhanced blood vessel function.

EXCOR Active Driving System for the EXCOR Pediatric VAD IDE Study

The purpose of this study is to evaluate the device performance and monitor the safety and effectiveness of the Berlin Heart EXCOR Active Driving System while being used with the approved EXCOR Pediatric Ventricular Assist Device. EXCOR Active Driving System is intended for use with the approved EXCOR Pediatric VAD. The EXCOR Pediatric VAD is intended to provide mechanical circulatory support as a bridge to cardiac transplantation for pediatric patients. Pediatric candidates with severe isolated left ventricular or biventricular dysfunction who are candidates for cardiac transplant and require circulatory support may be treated using the EXCOR Pediatric. EXCOR Active is intended for use in a clinical setting. EXCOR Active can be used in any kind of hospital unit (e.g. OR, ICU, intermediate care unit or general care unit). The driving unit may be moved between clinical units using the caddy or baby buggy; however, a patient must always be accompanied by a person trained in the use of the manual pump and emergency procedures during transport in the event of an emergency. The driving unit can be transported during operation.

A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Heart Failure

This study is open to adults aged 18 or above legal age with heart failure. People can join the study if they have heart failure symptoms and a left ventricular ejection fraction (LVEF) of 40% or more. The purpose of this study is to find out whether vicadrostat (BI 690517) in combination with empagliflozin helps people with heart failure. Participants are put into 2 groups by chance. Every participant has an equal chance of being in each group. The groups are: * Vicadrostat/empagliflozin group: participants take vicadrostat/empagliflozin as tablets once a day. * Placebo/empagliflozin group: participants take placebo/empagliflozin as tablets once a day. Participants can stay in the study as long as they benefit from treatment and can tolerate it. During this time, they visit their doctors regularly. The doctors regularly check participants' health and take note of any unwanted effects. The study staff may also contact the participants by phone. Participants also regularly answer questions about their well-being. The study does not have a fixed duration. It continues until there is enough data to see if the treatment is working.

A Study to Test Whether Vicadrostat (BI 690517) in Combination With Empagliflozin Helps People With Heart Failure and a Weak Pumping Function of the Left Side of the Heart

This study is open to adults with chronic heart failure (HF) who have a reduced left ventricular ejection fraction (LVEF) of less than 40%. People can join the study if they have been diagnosed with chronic HF at least 3 months before they start on the study. The purpose of this study is to find out whether a medicine called vicadrostat, in combination with another medicine called empagliflozin, helps people with chronic heart failure. In this study, participants are put into 2 groups randomly. Participants have an equal chance of being in either group. One group takes vicadrostat/empagliflozin tablets, and the other group takes placebo/empagliflozin tablets. Placebo tablets look like vicadrostat tablets but do not contain any medicine. Participants take the study medicines as tablets once a day for between about 6 months and about 3.5 years. During this time, they can continue their regular treatment for heart failure. Participants can stay in the study as long as they benefit from treatment and can tolerate it, for a maximum of about 3.5 years. During this time, they visit the study site regularly. The exact number of visits is different for each participant, depending on how long they stay in the study. The study staff may also contact the participants by phone for some visits. Participants also regularly answer questions about their well-being. The doctors document when participants experience worsening of their heart failure symptoms, go to hospital due to heart failure or die during the study. The time until these events are observed is compared between the two treatment groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.

Virtual Human Twins as Tools for Personalized Clinical Care in Heart Failure With Preserved Ejection Fraction: a Pilot Study

Heart failure (HF) is a heterogeneous clinical syndrome characterized by substantial inter-individual variability in pathophysiology and response to treatment. Precision medicine approaches are therefore needed to better account for this heterogeneity and tailor therapeutic strategies to individual patients. Virtual human twins represent one such approach, integrating multimodal clinical, biological, imaging, physiological, and omics data into patient-specific computational models to model disease mechanisms and predict individual therapeutic response. VITAL-HF is a prospective cohort pilot study designed to clinically evaluate the ability of the VITAL cardiovascular virtual human twin to predict individual response to spironolactone in patients with HF. Adult patients with HF with left ventricular ejection fraction (LVEF) \> 40% who have a clinical indication for spironolactone as part of routine care will be enrolled and followed for 3 months. The primary objective is to assess the ability of the VITAL cardiovascular virtual human twin to discriminate responders from non-responders to spironolactone. Response is defined as a ≥20% reduction in NT-proBNP levels 3 months after spironolactone initiation. Virtual twin predictions will be generated for research purposes only and will not influence treatment decisions or patient management.

Neural Cardiac Therapy for Heart Failure Study (NECTAR-HF)

The NECTAR-HF feasibility trial is designed to evaluate the application of right vagal nerve stimulation in heart failure patients with a New York Heart Association Class III, an ejection fraction equal to or less than 35 %, and a narrow QRS duration equal to or less than 130 ms.

Microvascular Dysfunction Assessment to Predict Left Ventricular Reverse Remodeling

Patients presenting with idiopathic dilated cardiomyopathy and left ventricle dysfunction (LVEF \<40%), naive of anti-remodeling cardiac medical therapy, will undergo invasive coronary microvascular assessment based on thermodilution. The primary endpoint, namely the left ventricle reverse remodeling, will be assessed after 12 months of optimal medical therapy based on transthoracic echocardiography. The primary endpoint will be evaluated by an independent central core lab. Patients enrolled in the study will be followed for a period of 5 years to monitor their clinical status. During the study period participants may undergo multimodality diagnostic tests including ECG telemetry monitoring, cardiopulmonary exercise testing, cardiovascular cardiac magnetic resonance.

Voice-based Outcome Identification and Clinical Evaluation in Heart Failure

VOICE-HF is a clinical study designed to evaluate the performance of a novel non-invasive software device (Noah Labs Vox) that uses vocal characteristics to estimate DHF risk and has strong potential for clinical success. This study will compare the performance of Noah Labs Vox with the contemporary performance of commonly used weight-based remote monitoring rules and applications to determine efficacy and safety.