Hypertrophic Cardiomyopathy

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 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 studying the quality of life in adults with hypertrophic cardiomyopathy HCM, thoracic aortic dilatation TAD, and radiation-induced heart disease RIHD who are not suitable candidates for surgery. This observational study aims to understand how these heart conditions affect patients daily lives and well-being. The research seeks to identify risk factors linked to lower quality of life and changes over time to improve long-term management. Participants are adults diagnosed with HCM, TAD, or RIHD who are visiting the Cleveland Clinic for the first time for cardiac evaluation without prior or planned surgery. They will complete the Cardiac Quality of Life QOL Survey electronically at three points baseline, 3 months, and 9 months. The survey covers five areasglobal, physical, emotional, social, and spiritual healthand measures self-efficacy and resilience. During the study, participants will provide information through these surveys to help assess their health status across multiple domains. Researchers will compare results at 3 and 9 months to baseline to understand changes in quality of life and the impact of heritability and radiation-induced disease. The total participation time is about nine months, with ongoing monitoring through outpatient clinic visits and electronic questionnaires.

Researchers are evaluating the long-term safety of HRS-1893 in people with hypertrophic cardiomyopathy, a condition affecting the heart muscle. This phase 2 clinical trial focuses on monitoring potential side effects and heart function changes over time. The study is sponsored by Shandong Suncadia Medicine Co., Ltd. and aims to provide important information about how this medication affects heart health in this population. Participants receive the study drug HRS-1893 in tablet form. The trial includes two groups one for obstructive hypertrophic cardiomyopathy and one for non-obstructive hypertrophic cardiomyopathy. This is an open-label, non-randomized study where all participants receive the medication. The treatment period and follow-up involve regular assessments to monitor safety and heart function. During the study, participants will undergo evaluations including tracking adverse events and monitoring heart function through left ventricular ejection fraction measurements over about one year. Additional tests include measuring cardiac biomarkers like troponin and NT-proBNP at 24 and 52 weeks. Participants will also be monitored for compliance and safety throughout the study, which lasts approximately one year, with the last data collection expected by December 2027.

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 conducting a randomized controlled trial to assess a new digital health tool called Prioritize Personalize Prescribe EXercise P3-EX. This tool is designed to help physicians prescribe personalized exercise programs to adults with cardiovascular disease CVD risk factors such as obesity, hypertension, dyslipidemia, and diabetes. The trial aims to test the usability and satisfaction of P3-EX compared to a generic exercise prescription method called the American College of Sports Medicine Physical Activity Vital Sign ACSM-PAVS. In the study, 24 physicians will each recruit two patients with CVD risk factors, assigning one patient to receive an exercise prescription via P3-EX and the other to receive the ACSM-PAVS prescription in a randomized crossover design. Patients will follow their prescribed exercise programs unsupervised for 12 weeks, with virtual weekly oversight from University of Connecticut Graduate Research Assistants. The P3-EX tool uses cardiovascular health scoring and tailored exercise recommendations based on the patients highest risk factors, while ACSM-PAVS provides a general exercise guideline. Patients will record their exercise using a self-report diary, and receive exercise guidance through virtual visits and weekly emails. Throughout the 12 weeks, patients will attend in-person visits before and after the intervention to assess CVD risk factors, physical activity levels using accelerometers, and satisfaction with the exercise programs. Physicians and patients will complete usability questionnaires shortly after exercise prescription delivery to evaluate feasibility and acceptability. The study will also analyze changes in cardiovascular health markers, exercise adherence, and physical activity to explore preliminary efficacy. The total participation includes initial assessments, 12-week exercise monitoring with virtual support, and follow-up evaluations.

Researchers are evaluating the safety, tolerability, and effectiveness of a drug called HRS-1893 in adults with non-obstructive hypertrophic cardiomyopathy, a heart condition. This Phase II randomized, double-blind, placebo-controlled study aims to better understand how different doses of HRS-1893 affect the heart and plasma drug levels in this patient group. The study is sponsored by Shandong Suncadia Medicine Co., Ltd. Participants will be randomly assigned to one of four groups low-dose HRS-1893, low-dose placebo, high-dose HRS-1893, or high-dose placebo. The study includes up to 14 weeks of monitoring to assess safety and heart function, with key focus on left ventricular ejection fraction and adverse events. Different dosing regimens will be tested to evaluate the drugs impact. During the study, participants will undergo regular assessments including heart function tests and blood tests to measure markers such as cardiac troponin and peak oxygen uptake. Researchers will closely monitor adverse effects and heart performance over about 12 to 14 weeks. The total duration of participation includes screening, treatment, and follow-up to ensure thorough evaluation of HRS-1893s effects and safety profile.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

Researchers are evaluating the effectiveness and safety of HRS-1893 tablets in treating patients with obstructive hypertrophic cardiomyopathy, a condition that affects the heart muscle. This Phase III study is sponsored by Shandong Suncadia Medicine Co., Ltd. and aims to assess how well HRS-1893 works compared to a placebo. The study focuses on patients aged 18 to 85 years who meet specific diagnostic and heart function criteria. Participants will be randomly assigned to receive either HRS-1893 tablets or placebo tablets in a double-blind manner, meaning neither the participants nor the researchers know which treatment is given. The treatment period lasts 24 weeks, during which the clinical response rate to HRS-1893 will be evaluated. Secondary outcomes include tracking major heart-related events, adverse effects, and changes in quality of life measured by the Kansas City Cardiomyopathy Questionnaire at weeks 12 and 24. Throughout the study, participants will undergo echocardiographic assessments to monitor heart function and other laboratory tests to ensure safety. They will be closely monitored for any adverse events over approximately 29 weeks. Participants are expected to follow the study protocol strictly and provide informed consent before joining. The total participation time includes treatment and follow-up to evaluate safety and outcomes comprehensively.

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.