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 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 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 Phase 1 study to evaluate the safety and effectiveness of allogeneic neonatal mesenchymal stromal cells nMSCs for treating Dilated Cardiomyopathy DCM. The study aims to determine if intravenous infusions of nMSCs can improve heart function and left ventricular ejection fraction in young adult and pediatric patients aged 4 to 40 years. The study is open-label and involves both adult and pediatric groups to assess safety, feasibility, and the maximum tolerated dose of the cell therapy. Participants will receive intravenous infusions of nMSCs every 30 days for a total of three infusions. Adults 16 to under 40 years will be enrolled in Phase 1A, with escalating doses given on days 0, 15, and 30. Pediatric patients 4 to under 16 years will be enrolled in Phase 1B after adult phase completion and regulatory review, with doses adjusted by body weight and similar infusion schedules. Dose escalation follows a 33 study design. After infusions, follow-up visits will occur at 3 months, 6 months, and 1 year. Participants will undergo assessments including blood tests, echocardiograms, electrocardiograms, physical exams, a 6-minute walk test, cardiac MRI, and quality-of-life questionnaires at various timepoints before and after treatment. Researchers will monitor for adverse events, heart function changes, and quality-of-life improvements over a total participation duration of about 14 months. Financial compensation and parking reimbursement are provided, and patients are not required to stay overnight after infusions.

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.

This clinical trial is studying patients with combined pre- and post-capillary pulmonary hypertension CpcPH linked to left heart disease LHD. It aims to evaluate the safety and effectiveness of a new device called the Multi-Pole Pulmonary Artery Radiofrequency Ablation Enhancor System, compared to standard medical therapy. The study includes patients with chronic heart failure who are stable and already receiving the best available medical treatments for left heart failure. Participants will be randomly assigned to one of two groups the intervention group will receive pulmonary artery denervation PADN using the Enhancor System plus guideline-directed medical therapy GDMT, while the control group will undergo a placebo procedure plus GDMT. Before randomization, some operators may perform up to two roll-in PADN procedures to gain experience. Participants will be followed for 3 years, with clinical assessments at 1, 6, 12, 24, and 36 months. Control subjects who experience a primary efficacy endpoint event may cross over to receive PADN after 24 months if eligible. During the study, participants will undergo various assessments including heart function tests, walking distance tests, biomarker blood tests NT-proBNP, and quality of life questionnaires Kansas City Cardiomyopathy Questionnaire at several time points. Safety will be monitored closely, especially within 30 days after the procedure. Researchers will track heart failure events, hospitalizations, device implantations, heart transplantations, and cardiovascular deaths over the 3 years. Participants are expected to comply with medication and follow-up visits throughout the study.

Researchers are evaluating the safety, tolerability, and pharmacokinetics of the drug HJB647 in people with chronic stable heart failure who have reduced or mildly reduced ejection fraction HFrEFHFmrEF. This Phase 1 trial is designed as a multi-center, randomized, participant- and investigator-blinded, placebo-controlled crossover study to better understand how two different doses of HJB647 affect these participants. The study includes participants with stable heart failure under standard care with sacubitrilvalsartan therapy. Participants are randomly assigned to one of three treatment sequences, each lasting 3 days, which include two different doses of HJB647 and a placebo, all given as capsules by mouth. During the dosing period, participants stay in a controlled setting for close monitoring. Following the dosing, there is an in-clinic follow-up visit on Day 7 and a safety phone call on Day 33 to monitor any adverse events or vital sign changes. Throughout the study, participants undergo monitoring to track adverse events and changes in vital signs up to 33 days. Pharmacokinetic measurements such as maximum drug concentration, time to reach maximum concentration, and area under the concentration-time curve are collected up to 7 days. The study lasts approximately one month, including dosing, follow-up visits, and safety assessments to evaluate the drugs behavior and tolerability in this patient group.

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 effects of inspiratory muscle training IMT combined with cardiac rehabilitation CR on cardiovascular function in patients with heart failure with reduced ejection fraction HFrEF. The study aims to understand how adding IMT to CR influences exercise responses and muscle blood flow in this patient group receiving guideline-directed medical therapy. Participants are randomly assigned to one of two groups one performing IMT at 40% of maximal inspiratory pressure for 30 minutes, three days a week over 12 weeks, and a sham group performing IMT at 5% of maximal inspiratory pressure with the same schedule. The PowerBreathe device is used for IMT, which requires forceful inhalation against a resistance valve. The study is conducted in a double-blind parallel design to compare these two interventions. During the study, participants undergo assessments at baseline and after 12 weeks, measuring changes in locomotor muscle blood flow during exercise and the respiratory muscle cost of breathing VO2. Researchers monitor adherence and safety throughout the treatment period. The total participation time spans the 12-week intervention with evaluations focused on exercise-related cardiovascular improvements.

Researchers are studying AZD4063 in adults with phospholamban PLN R14del dilated cardiomyopathy to evaluate its safety, tolerability, and how the drug behaves in the body after single and multiple doses. This Phase 1, first-in-human, unblinded study includes groups receiving increasing doses to understand the effects and risks of AZD4063 in this specific heart condition. The study has two main parts single ascending dose SAD cohorts where participants receive one dose of AZD4063 by subcutaneous injection, and multiple ascending dose MAD cohorts where participants receive repeated doses. Optional additional groups may be added based on safety and drug behavior data from the initial cohorts. Each part includes a screening period, treatment with AZD4063 injections, and follow-up to monitor participants. Participants will undergo screening to confirm eligibility, then receive AZD4063 injections according to their assigned group. Throughout the study, researchers will monitor adverse events, measure drug levels in the blood, and evaluate effects on heart tissue and function through tests including echocardiography and biopsies. The study monitors participants for up to several months depending on the dose group, ensuring close safety and response tracking.