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 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 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 areas—global, physical, emotional, social, and spiritual health—and 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 evaluating a new digital health tool called Prioritize Personalize Prescribe EXercise (P3-EX) designed to help physicians prescribe personalized exercise plans to adults with cardiovascular disease (CVD) risk factors such as obesity, hypertension, dyslipidemia, and diabetes. This pilot randomized controlled trial aims to test the usability and satisfaction of P3-EX compared to a standard exercise prescription method (ACSM Physical Activity Vital Sign) among physicians and their patients. The study addresses barriers physicians face in prescribing exercise, including lack of time, training, and tools. Physicians recruited for the study will each recruit two patients with CVD risk factors. One patient receives a personalized exercise prescription using P3-EX, and the other receives a generic exercise program based on ACSM guidelines, delivered in a random crossover design. Patients will follow their assigned exercise plans unsupervised for 12 weeks with virtual weekly support from graduate research assistants. The P3-EX tool assesses cardiovascular risk factors, prioritizes the greatest risk, and creates a tailored Frequency, Intensity, Time, and Type (FITT) exercise prescription. Patients will record their exercise activities in a diary and receive weekly progress reports and guidance. Participants will attend several in-person visits for assessments including cardiovascular risk factors, physical activity levels measured by accelerometry, and blood tests. Physicians and patients will rate the feasibility and acceptability of each prescription method shortly after delivery. Patient exercise adherence and changes in cardiovascular health and physical activity will be monitored over 12 weeks. The study includes virtual visits for guidance and ends with follow-up assessments to evaluate patient satisfaction and health outcomes. The total participation time for patients covers baseline and post-intervention visits plus the 12-week exercise period.

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 drug's 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-1893's effects and safety profile.

Researchers are evaluating the effect of AZD0780, an oral PCSK9 inhibitor, compared with a placebo in reducing the risk of major adverse cardiovascular events plus (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or at high risk for a first ASCVD event. This phase 3, randomized, placebo-controlled, and double-blind study aims to assess the time to first MACE-PLUS event over up to approximately 54 months from randomization until the primary analysis censoring date. Participants will be randomly assigned to receive either oral AZD0780 once daily or an oral placebo once daily. The study includes a parallel-group design with two arms: the experimental AZD0780 group and the placebo comparator group. After the primary analysis censoring date, a study closure visit will be scheduled as the final visit for each participant. During the study, participants will be monitored for the occurrence of cardiovascular events including myocardial infarction, stroke, urgent coronary revascularization, cardiovascular death, major adverse limb events, and all-cause mortality. Researchers will assess these events through regular follow-up visits up to approximately 54 months. The study includes detailed safety monitoring and outcome evaluations to understand the effects of AZD0780 compared to placebo in this population at risk for cardiovascular events.

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 intervention's feasibility and effects on patients with cardio-neurovascular conditions.