Takotsubo Cardiomyopathy

Researchers are evaluating the bioequivalence between two formulations of HRS-1893 tablets in healthy adults aged 18 to 55 years. The study aims to compare how the body absorbs and processes each formulation, while also assessing their safety and tolerability. This phase 1 trial is sponsored by Shandong Suncadia Medicine Co., Ltd. and uses a randomized crossover design. Participants will receive both the test and reference formulations of HRS-1893 tablets orally during different periods of the study. The study evaluates peak concentration, area under the plasma concentration-time curve, time to peak concentration, elimination half-life, and other pharmacokinetic measures from Day 1 to Day 17. Safety assessments include monitoring adverse events, ECG, echocardiogram, and vital signs up to Day 21

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 interventions 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 in patients with various arrhythmias. This device is studied in individuals undergoing clinically indicated catheter mapping and ablation procedures for managing arrhythmias such as ventricular tachycardia, atrial fibrillation, and premature ventricular contractions. Participants will undergo catheter mapping and ablation using the investigational multi-electrode mapping catheter during their scheduled procedures. The catheter is used to perform high-density mapping of the hearts electrical activity to guide treatment. The study focuses on the devices safety, including serious adverse events within 7 days post-procedure, and its ability to complete all required pre-ablation mapping tasks. Evaluation includes physician assessments of the catheters deployment, maneuverability, and signal quality. During the study, participants will be monitored for safety outcomes up to 7 days after the procedure. Researchers will collect data on adverse events, mapping completion, and device performance. Participants must comply with all pre-procedure, post-procedure, and follow-up testing and requirements. The studys total duration includes the procedure day and a 7-day follow-up period to assess device-related safety and effectiveness parameters.

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 protein breaks down and forms amyloid plaques that build up in organs, causing damage. There are two types wild-type ATTR, which occurs with aging, and variant ATTR caused by inherited defective TTR genes. This study focuses on adults who have inherited a pathogenic TTR gene variant but do not yet show symptoms, aiming to see if early treatment can prevent or delay disease development. The trial is a Phase 3, randomized, double-blind, placebo-controlled study evaluating prevention of ATTR cardiomyopathy and polyneuropathy. Participants will be randomly assigned to receive either acoramidis, a drug designed to stabilize the TTR protein and prevent amyloid formation, or a matching placebo. The study drug is taken orally twice daily at a dose equivalent to 800 mg acoramidis HCl BID. Participants will be adults aged 18 to 75 years whose age falls within 10 years younger or older than their predicted age of disease onset based on family history or actuarial tables. The trial will last approximately 7 years from randomization or until study end. During the study, participants will be monitored regularly with evaluations to detect the development of ATTR cardiomyopathy or polyneuropathy. Researchers will assess time to disease onset using centrally adjudicated criteria. Safety and adherence will be tracked throughout the trial. This long-term study will help determine if early treatment with acoramidis can delay or prevent symptoms in asymptomatic carriers of pathogenic TTR variants.

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.

The WILLEM study is a multicenter observational trial focusing on high-risk cardiac patients with arrhythmias or abnormal ECG patterns. It aims to validate a cloud-based AI-powered ECG analysis platform called Willem173, which is designed to detect and predict cardiac abnormalities. The study compares the AI diagnoses with cardiologists evaluations and assesses the platforms ability to delay or avoid severe cardiac events such as sudden death. Participants include patients with relevant cardiac arrhythmias or diseases and at least one ECG record with over one year of follow-up data. Participants are divided into two groups a training group to develop new AI methodologies and a test group to evaluate the AIs performance and avoid overfitting. The AI platform analyzes cardiac electrical signals lasting 10 seconds or more, collected from various devices including hospital ECG machines, Holter monitors, wearable ECG patches, and telemedicine interfaces. Cardiology experts review all data to label arrhythmias and patterns. Both retrospective and prospective patient data are used. During the study, participants provide ECG data and clinical information for analysis. Researchers monitor primary outcomes such as real-time detection of cardiac arrhythmias within minutes of ECG recording. Secondary outcomes include survival, major cardiovascular events, rehospitalization, and quality of life measured one year after the initial ECG or enrollment. Informed consent is obtained from patients or authorized relatives if patients cannot consent themselves. The study is conducted until November 2026, with ongoing data collection and evaluation.

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.