Takotsubo Cardiomyopathy

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 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.

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.

This research investigates the Willem™ AI-powered ECG analysis platform designed to detect arrhythmias and abnormal cardiac patterns in high-risk cardiac patients. The study aims to evaluate whether this AI tool can classify and predict arrhythmic episodes at the level of a cardiologist and potentially delay or prevent serious cardiac events like sudden death. The study includes patients with cardiac arrhythmias or abnormal ECG patterns and requires at least one ECG record with over one year of follow-up data. The study is observational and multicenter, comparing AI-driven ECG analysis with expert cardiologist diagnoses. Patients are divided into a training group, where new algorithms are developed, and a test group, which evaluates these algorithms to avoid overfitting. The platform analyzes electrical cardiac signals lasting 10 seconds or more from various medical devices, including hospital 12-lead ECGs, telemetries, Holter monitors, wearable ECG devices, and mobile telemetry patches. Participants will provide ECG data and clinical information, which expert cardiologists will label for arrhythmias. The study tracks outcomes such as arrhythmia detection time (from real-time to 7 minutes), survival, major adverse cardiovascular and cerebrovascular events, rehospitalization, and quality of life over one year after the first ECG or enrollment. Consent is required, and patients unable to consent may have a relative provide it. The study will assess the AI platform's accuracy, sensitivity, and specificity in detecting cardiac abnormalities.

Atrial Fibrillation (AF) is a common heart rhythm problem affecting many adults over 45. While most tolerate AF well, some develop heart failure due to weakened heart pumping. This research aims to understand why some people with AF develop heart failure by studying specific genetic differences in patients who develop heart failure triggered by AF compared to those who do not. The study will analyze genetic variants linked to heart muscle disease in three groups: patients with AF-induced heart failure who recover after treatment, patients with AF who do not develop heart failure, and patients with AF-related heart failure who do not recover after treatment. The study will include 92 patients with AF-induced heart failure who improve after treatments such as catheter ablation or cardioversion, 184 patients with AF but preserved heart function, and 23 patients with AF and heart failure who do not improve after treatment. Researchers will test a selected set of genetic variants known to cause heart muscle disease to find differences among these groups. This focused approach aims to be cost-effective and avoid unclear genetic results. Participants will undergo baseline genetic testing on one day to identify these genetic variants. The main measure is the prevalence of these gene variants in the AF-induced heart failure group compared to controls. The findings could help doctors identify patients at risk for heart failure during AF, guide treatment decisions, and suggest family screening when needed. The study is sponsored by Barts & The London NHS Trust and will collect data until May 2027.

Genetic cardiomyopathy is a condition linked to various gene variants that can lead to heart failure, irregular heart rhythms, and sudden cardiac death. This research focuses on patients who have a personal or family history of specific gene variants (TTN, MYBPC3, LMNA, FLNC, or DSP) known to cause different forms of cardiomyopathy. The study aims to understand how existing and new biomarkers can identify and predict disease progression in these gene-positive individuals, addressing the current challenge of distinguishing patients who will develop severe symptoms from those who may remain unaffected. The study will observe gene-positive participants and control participants with a family history but negative genetic testing. Researchers will collect and analyze biomarkers from blood and urine, as well as electrocardiographic and imaging data, following established cardiomyopathy and heart failure guidelines. The main focus is on how well these biomarkers perform over three years to detect pre-clinical disease and predict cardiomyopathy progression. The study plans to recruit around 750 participants across different gene variant groups. Participants will undergo regular assessments involving biomarker sampling and imaging over a three-year period, with long-term data linkage to track disease development and progression. Researchers will monitor biomarker levels and correlate them with clinical outcomes to evaluate their usefulness in improving disease surveillance. The study includes genetic testing, clinical evaluations, and will assess natural history aspects of genetic cardiomyopathies. This will help explore less burdensome monitoring alternatives to frequent heart scans and tests. The trial is expected to conclude by March 2027.

Researchers are evaluating optimized pharmacologic treatments for patients with Takotsubo Syndrome, a condition often referred to as broken heart syndrome. This large randomized registry clinical trial aims to include 1000 participants registered in SWEDEHEART to better document effective treatments, as current data from large patient groups are lacking. The trial is a Phase 4 study sponsored by Vastra Gotaland Region and is designed as an open-label, multinational, multicenter trial. Participants are randomly assigned to different treatment groups. One group receives an adenosine infusion for 3 hours followed by oral dipyridamole twice daily until left ventricular function normalizes or up to about one month. Another group receives usual care per European Society of Cardiology recommendations. A separate randomization compares oral apixaban twice daily until normalization of heart function or about one month versus no anticoagulant therapy. The study monitors heart function with echocardiographic assessments at 48-96 hours and possibly later. During the study, participants undergo regular heart ultrasounds to assess wall motion and ejection fraction, along with monitoring for events such as death, cardiac arrest, heart failure, thromboembolic events, and bleeding. The trial collects data up to 30 days after treatment begins. Researchers also track heart rhythm problems and use standardized scoring to evaluate heart muscle movement. Safety and treatment outcomes are closely observed throughout the study period, which lasts until December 2028.