Dilated 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 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 the safety and effectiveness of allogeneic neonatal mesenchymal stromal cells (nMSCs) for treating Dilated Cardiomyopathy in young adult and pediatric patients aged 4 to 30 years. This Phase 1 open-label study aims to determine if intravenous infusions of these cells can improve heart function, specifically left ventricular ejection fraction, while assessing the maximum tolerated dose and monitoring for serious side effects. The study includes two groups: adults aged 18 to 30 years (Phase 1A) and children aged 4 to under 18 years (Phase 1B). Participants receive intravenous nMSC infusions at escalating doses on days 0, 15, and 30. Pediatric doses are based on body weight. Treatments last about 30 to 60 minutes per infusion. Phase 1B starts after adult phase completion and review. After infusions, pediatric patients stay overnight near the hospital for safety monitoring; adults do not require overnight stays. Participants have a baseline visit before treatment, followed by check-ins after each infusion, phone contact 30 days after the last infusion, and in-person visits at 3, 6, and 12 months. Assessments include blood tests, echocardiograms, electrocardiograms, physical exams, a 6-minute walk test, cardiac MRI, and quality-of-life questionnaires. Researchers track heart function changes, patient safety, and quality of life during the total 14-month participation. Left ventricular ejection fraction and adverse events are key outcome measures.

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, tolerability, and pharmacokinetics of the drug HJB647 at two different doses in adults with chronic stable heart failure who have reduced or mildly reduced ejection fraction (HFrEF/HFmrEF). This Phase 1 study is designed as a multi-center, randomized, double-blind, placebo-controlled crossover trial to carefully assess these aspects in this specific heart condition. Participants will be randomly assigned to one of three treatment sequences for three consecutive days, receiving either a low dose of HJB647, a high dose of HJB647, or a placebo. The study drug and placebo are taken orally as capsules. Participants will stay at the study site during dosing for close monitoring, followed by a clinic visit on Day 7 and a safety phone call on Day 33 to track their health. During the study, researchers will monitor adverse events and significant changes in vital signs over 33 days. They will also measure how the body absorbs and processes HJB647, including drug concentration levels and timing up to 7 days after dosing. This careful follow-up aims to ensure participant safety and gather important information about the drug's behavior in the body throughout the trial period.

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 effects of adding inspiratory muscle training (IMT) to cardiac rehabilitation (CR) on cardiovascular function in patients with heart failure with reduced ejection fraction (HFrEF). The study aims to compare exercise responses in these patients, who have specific heart failure symptoms and are receiving guideline-directed medical therapy. This interventional trial is sponsored by Mayo Clinic and uses a randomized, double-blind design. Participants will be assigned to one of two groups: one group performs IMT at 40% maximal inspiratory pressure (MIP) and the other performs a sham IMT at 5% MIP. Both groups use the PowerBreathe device, an inspiratory pressure threshold trainer, for 30 minutes, three times a week, over 12 weeks. The device blocks airflow until a threshold pressure is reached by forceful inhalation, training the inspiratory muscles. During the trial, participants will be monitored at baseline and after 12 weeks to assess changes in locomotor muscle blood flow during exercise and in the respiratory muscle's oxygen cost of breathing (VO2). The study involves exercise testing and assessments related to cardiovascular and respiratory function. The total trial participation lasts 12 weeks, with careful monitoring to evaluate the impact of the training on exercise responses in heart failure patients.

Researchers are evaluating AZD4063 in adults with phospholamban (PLN) R14del dilated cardiomyopathy to assess its safety, tolerability, and how the body processes the drug after single and multiple doses. This Phase 1, first-in-human study includes various dose levels to better understand how AZD4063 works in this specific heart condition. The study has two main parts: single ascending dose (SAD) and multiple ascending dose (MAD) cohorts. Participants in SAD receive one subcutaneous injection of AZD4063 at increasing doses across three groups, followed by a follow-up period. After reviewing SAD data, the MAD part begins, involving multiple subcutaneous doses across three groups with follow-up. Optional cohorts may be added depending on emerging safety and pharmacokinetic data. Participants will undergo screening before each part and receive injections as assigned to their cohort. Researchers will monitor for adverse events and measure drug levels in the blood over several weeks. They will also assess heart function and molecular markers to understand how the drug affects the condition. The study includes close safety monitoring throughout, with total observation periods ranging up to 155 days depending on the cohort.

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.