Myocarditis

Researchers are investigating acute myocardial inflammation, a complex condition that includes acute cellular cardiac allograft rejection (ACR), cardiac sarcoidosis (CS), and immune checkpoint inhibitor induced myocarditis (ICIM). This study aims to evaluate the accuracy of [68Ga]Ga-PentixaFor PET/CT imaging for detecting inflammatory cells in these patients, offering a potentially non-invasive diagnostic option. The study is a phase 2 trial focusing on these specific heart inflammation conditions where diagnosis is currently challenging. Participants will receive an intravenous injection of a maximum of 50 micrograms of PentixaFor labeled with 150 ±15 MBq of Gallium-68 ([68Ga]) as a bolus 60 ±15 minutes before undergoing PET/CT imaging. The treatment involves this imaging procedure for all three patient groups (ACR, CS, ICIM) to assess the presence and characteristics of myocardial inflammation. During the study, researchers will evaluate imaging results by analyzing lesion number, location, and standardized uptake value (SUV) over one year. They will also monitor toxicity data for safety assessment. Participants will have regular clinical follow-ups at the cardiology department. The study involves signing informed consent and includes monitoring for any adverse effects related to the imaging agent or procedures throughout the study duration.

Researchers are evaluating a new 10-minute cardiovascular magnetic resonance (CMR) imaging protocol designed to improve current CMR procedures for patients with various heart conditions, including coronary artery disease, cardiomyopathies, and other cardiac diseases. The study aims to develop a standardized, contrast-free imaging method that can be applied to about 70% of cardiac patients. The goal is to assess whether this shorter protocol enhances diagnostic decision-making and reduces healthcare costs. The study involves two groups: healthy volunteers over 18 years old without significant cardiovascular or respiratory conditions, and patients over 18 years who require a clinically indicated CMR exam. The new protocol focuses on heart function and tissue characterization without using contrast agents. Researchers will compare the new 10-minute protocol to standard CMR imaging, evaluating its clinical feasibility, performance, and cost-effectiveness in different patient populations. Participants will undergo CMR scans using both the new and standard protocols. Researchers will monitor diagnostic results, scan completion rates, scan sequence times, adverse events, and cost differences between methods. Various heart tissue measurements and reproducibility between different readers and scanners will also be assessed. The study spans from 2019 to 2025, with ongoing safety monitoring during imaging sequences and a focus on improving the efficiency and quality of cardiac imaging.

Researchers are evaluating whether two different formulations of HRS-1893 tablets are bioequivalent in healthy adults aged 18 to 55 years. This Phase 1 study aims to compare how the body absorbs and processes these two tablet versions, while also assessing their safety and tolerability. The study is sponsored by Shandong Suncadia Medicine Co., Ltd. and focuses on the condition of cardiomyopathy. Participants will be randomly assigned to receive either the test formulation or the reference formulation of the HRS-1893 tablet taken orally. The study includes precise monitoring of drug levels in the blood from Day 1 to Day 17, measuring peak concentration and overall exposure. Safety assessments such as ECG, echocardiogram, vital signs, and adverse event monitoring occur from Day 1 to Day 21, with no masking or blinding involved. During the study, participants will undergo blood tests to measure drug concentration over time, along with heart function tests and vital sign checks. Researchers will track any adverse effects and evaluate how well participants tolerate the treatments. The study involves multiple visits over several weeks, providing detailed information on how the tablets behave in the body and their safety profile.

Researchers are evaluating a predictive tool called the Multifactorial Dynamic Perfusion Index (MDPI) to estimate the risk of acute kidney injury after cardiac surgery involving cardiopulmonary bypass (CPB). This observational study involves adults and infants undergoing cardiac surgery, aiming to validate the MDPI in adults, develop a version for infants under 20 kg, and explore if the MDPI can predict other complications including mortality. The MDPI combines seven variables measured during CPB, many of which can be modified by the surgical team to potentially improve patient outcomes. The study is divided into three parts: first, validating the MDPI in 800 adult cardiac surgery patients from two centers using existing CPB monitors that collect data such as hematocrit, oxygen delivery, arterial pressure, and transfusions; second, developing a modified MDPI for 200 infants under 20 kg undergoing congenital heart surgery with additional infant-specific variables; and third, investigating whether the MDPI can predict other postoperative issues like low cardiac output, longer ICU stays, bleeding complications, and 30-day mortality. Data collection includes parameters recorded during surgery and postoperative creatinine values. Participants will undergo cardiac surgery with CPB, during which relevant physiological data will be continuously recorded by specialized monitors. After surgery, kidney function and other outcomes will be monitored for up to 48 hours, with extended follow-up for complications and mortality over 30 days. Researchers will analyze how well the MDPI predicts acute kidney injury and other clinical outcomes, aiming to incorporate the MDPI into real-time monitoring devices to guide therapeutic decisions during surgery.

Researchers are evaluating a preventive, multidisciplinary primary care intervention designed around a therapeutic garden to assess its acceptability among patients with cardio-neurovascular diseases. This study focuses on individuals suffering from various vascular conditions, including atrial fibrillation, heart failure (NYHA Class II), cardiomyopathies, ischemic stroke, and resistant hypertension. The main goal is to understand how patients and those involved in their care respond to this novel intervention. The intervention consists of a 6-month program that includes gardening activities, adapted physical exercise, nutritional workshops, and questionnaires to gather feedback. Participants may either take part in this multidisciplinary preventive action or choose not to receive the intervention but still complete questionnaires explaining their reasons. The study compares these two groups to identify acceptance rates and factors influencing participation. Participants will be involved for six months, during which their acceptance of the intervention and any obstacles or facilitators will be recorded. Researchers will assess the impact of the program through questionnaires and follow-up evaluations. The study monitors participants from enrollment through the end of treatment, aiming to gather comprehensive data on the intervention's feasibility and effects on patients with cardio-neurovascular conditions.

Researchers are evaluating the safety and feasibility of a new paddle-shaped, high-density, multi-electrode mapping catheter designed to map the atrial and ventricular regions of the heart. This study focuses on patients undergoing catheter mapping and ablation procedures to manage various cardiac arrhythmias, including atrial fibrillation, atrial tachycardia, ventricular tachycardia, and premature ventricular contractions. The trial is sponsored by Biosense Webster, Inc. and aims to monitor serious and non-serious adverse events related to the investigational catheter. Participants scheduled for a clinically indicated catheter mapping and ablation procedure will have the procedure performed using the investigational mapping catheter. The catheter is designed to provide detailed mapping of heart arrhythmias to guide the ablation therapy. The study period includes the index procedure and up to seven days of follow-up to assess safety and procedural success. Physicians may use the catheter for endocardial and, if indicated, epicardial mapping during the procedure. During the study, participants will undergo the catheter mapping and ablation procedure, and researchers will evaluate the catheter's deployment, visualization, maneuverability, and signal quality. Safety is monitored by recording any serious or non-serious adverse events within seven days after the procedure. Participants must comply with all pre-, post-, and follow-up testing and requirements, with the total relevant monitoring lasting up to seven days post-procedure.

Researchers are evaluating the use of advanced AI-Echo algorithms to assist clinicians in interpreting echocardiograms, focusing on key heart parameters like size, function, and valve disease severity. The study aims to improve consistency among clinicians, workflow integration, and risk stratification for diseases such as genetic cardiomyopathy, ischemic heart disease, cardiac amyloidosis, and hypertrophic cardiomyopathy. This observational trial is sponsored by the Mayo Clinic and uses real-world data and EHR-based notifications for deployment. The study involves multiple arms targeting specific heart conditions, where AI analyzes transthoracic echocardiography (TTE) images to identify patients at high risk for these diseases. Clinicians order and interpret comprehensive TTEs enhanced by AI, and the study compares diagnostic testing rates and time to diagnosis across groups. Cluster-level randomization is used for implementation, with high-risk thresholds set to maximize sensitivity and predictive value. Participants are adults aged 18 years or older undergoing comprehensive TTEs at Mayo Clinic sites. The study measures outcomes including the number of patients diagnosed with the specific heart conditions confirmed by testing and the time from initial echo to diagnosis. Researchers track clinician usability and diagnostic consistency, integrating AI tools into clinical workflows to assess impact on patient care over the trial duration ending in 2028.

Researchers are evaluating whether abatacept, compared to a placebo, can reduce major adverse cardiac events (MACE) in people hospitalized with myocarditis caused by immune checkpoint inhibitors (ICI), a treatment for various cancers. This serious heart inflammation is a rare side effect of ICI therapy. Despite current treatment with corticosteroids and stopping the ICI, the risk of MACE remains high, ranging from 25% to 50%, much greater than myocarditis unrelated to ICI. Participants receive either abatacept or a placebo, both given alongside corticosteroids, to test the impact on MACE. Abatacept is administered intravenously at 10 mg/kg after randomization, again 24 hours later, then at 14 days, with an optional fourth dose at 28 days. The placebo group receives identical infusions on the same schedule. The study is randomized, double-blind, and placebo-controlled to ensure unbiased results. During the study, participants are closely monitored for heart-related events, including cardiovascular death, cardiac arrest, shock, arrhythmias, and heart failure, over six months. Researchers also assess myocarditis severity, troponin blood levels indicating heart damage, and other immune-related side effects. Safety and clinical status are evaluated at 90 days and six months after the first infusion. Overall participation lasts up to six months with ongoing assessments and care.

Transthyretin amyloidosis (ATTR) is a condition where the transthyretin (TTR) protein breaks apart and forms harmful amyloid plaques that build up in various organs, causing damage. There are two types: wild-type ATTR, which develops with age, and variant ATTR, which is inherited through a defective TTR gene. Amyloid buildup in the heart leads to transthyretin amyloid cardiomyopathy (ATTR-CM), and in nerves, it causes transthyretin amyloid polyneuropathy (ATTR-PN). Researchers are studying acoramidis, a drug designed to stabilize TTR protein to prevent or delay these diseases in adults who carry the inherited defective gene but have no symptoms yet. This clinical trial is a phase 3, randomized, double-blind, placebo-controlled study involving asymptomatic adults aged 18 to 75 who carry a pathogenic TTR gene variant. Participants will be randomly assigned to receive either oral acoramidis 712 mg twice daily or a matching placebo. The study will stratify participants based on their predicted age of disease onset and will follow them for up to approximately 7 years or until the study ends. During the study, participants will be regularly monitored for the development of ATTR-CM or ATTR-PN through centrally adjudicated assessments. The main measurement is the time until these conditions develop. The study also tracks safety and secondary outcomes such as the specific onset of ATTR-CM or ATTR-PN. Participants will attend study visits for evaluations including medical exams and tests over the course of the trial, which could last about 7 years or until the study concludes.

Researchers are studying cardiomyopathy, a major cause of heart failure that can lead to sudden cardiac death and often requires heart transplantation when standard treatments fail. This condition poses serious health risks, especially among young and middle-aged individuals, and impacts families emotionally. The study focuses on improving genetic diagnosis of cardiomyopathy in Korean patients by addressing the lack of population-specific genetic data and aims to find new disease mechanisms and diagnostic approaches through comprehensive genome analysis. The study collects clinical and genomic data from patients diagnosed with cardiomyopathy using whole genome sequencing (WGS). Blood samples are taken during outpatient visits or hospital stays, and demographic, clinical, imaging, and laboratory data are gathered. These data are integrated for detailed analysis to create a genetic profile specific to the Korean population. The study is part of a larger national project supported by Korean health agencies. Participants provide informed consent and undergo blood draws for genomic testing. Clinical information, imaging such as echocardiography and cardiac MRI, and cardiovascular event records are collected and securely stored without personal identifiers. Researchers will evaluate genomic profiles at enrollment and monitor cardiovascular events for up to five years. The study ensures confidentiality and follows standard heart failure care guidelines, with data used to enhance understanding and diagnosis of inherited cardiomyopathies.