Cardiomyopathy

Researchers are evaluating the safety, tolerability, and pharmacodynamics of 4D-310, a gene therapy, in adults with Fabry Disease who have heart involvement. This open-label, dose-escalation trial includes adult males and females aged 18 to 65 years and aims to understand how the treatment works after a single intravenous dose. Fabry Disease is a condition that affects multiple organs, including the heart, and requires new treatment approaches. Participants receive one single intravenous administration of 4D-310 at different dose levels as part of the study. The trial includes several dose groups, with some dose levels no longer enrolling. The study is conducted across multiple centers and is designed to carefully monitor responses to the gene therapy over time. During the study, participants will be regularly assessed for safety by tracking any adverse events for one year following treatment. Researchers will also monitor how the body responds to the therapy through various evaluations. The total participation time includes screening, treatment, and follow-up visits to ensure thorough observation of treatment effects and safety.

Researchers are investigating myocardial fibrosis in patients with heart failure, focusing on those with non-ischemic dilated cardiomyopathy (HFrEF phenotype) and hypertrophic cardiomyopathy (a subtype of HFpEF). The study explores the use of gallium-68-labeled fibroblast activation protein inhibitor positron emission tomography/computed tomography (68Ga-FAPI PET/CT) compared to the current standard, cardiac magnetic resonance imaging (CMR), to better detect and monitor fibrosis activity. This observational pilot study aims to improve non-invasive methods for assessing fibrogenesis and treatment effects. Participants will undergo 68Ga-FAPI PET/CT scans to evaluate myocardial fibrosis. The study includes patients with preserved or reduced left ventricular ejection fraction meeting specific imaging and diagnostic criteria. Recent echocardiograms, cardiac magnetic resonance imaging, and normal coronary angiogram or CT coronary angiography are required within specified timelines. The study is single-center and prospective, focusing on developing new assessment methodologies for future anti-fibrotic therapies. During the study, participants will be monitored through imaging assessments at baseline and after two years to measure 68Ga-FAPI uptake. Researchers will also correlate imaging findings with serum cardiac biomarkers and cardiovascular events. The study requires participants to have stable conditions without recent hospitalizations for heart failure and includes safety monitoring concerning kidney function and tolerance to procedures. The total participation duration may span over two years with repeated evaluations.

Researchers are evaluating the use of [18F]FT8, a diagnostic imaging agent, for detecting amyloidosis, including cardiac amyloidosis. This study aims to assess the safety and effectiveness of [18F]FT8 PET/CT scans in visualizing AL amyloid deposits in the heart, comparing its performance to established clinical methods such as echocardiography, MRI, and laboratory tests. The goal is to establish a reliable PET imaging protocol for direct diagnosis and differentiation of AL amyloidosis. Participants will receive a single intravenous injection of 10 b1 3 mCi of [18F]FT8, followed by a PET/CT scan to measure organ uptake using the standardized uptake value (SUV). The study includes both healthy volunteers and amyloidosis patients. The imaging and injection occur only once, and no additional treatments are administered. Clinical assessments and lab tests are done before and after the scan to monitor safety and gather diagnostic information. During the study, participants will undergo physical exams, cardiac function assessments, and tests of liver and kidney function before and after the PET/CT scan. Researchers will monitor safety from the time of injection up to seven days afterward, and evaluate organ uptake and biodistribution of [18F]FT8 at the time of the scan. Radiation exposure is also measured. Total participation involves a single visit for imaging and assessments, with follow-up safety monitoring over one week.

Researchers are evaluating the ability of [64Cu]FBP8, a new fibrin-binding PET imaging probe, to detect intracardiac blood clots in people with transthyretin or light chain cardiac amyloidosis who also have atrial fibrillation or atrial flutter. This pilot study aims to see if [64Cu]FBP8 PET combined with cardiac MRI can identify clots in over 90% of patients confirmed to have intracardiac thrombi by transesophageal echocardiogram (TEE). The study also explores links between clots and heart function and amyloid burden. Participants will receive an injection of [64Cu]FBP8 followed by simultaneous cardiac PET/MR imaging to detect intracardiac thrombi. This imaging approach is compared against TEE results as a reference standard. The study involves twenty individuals with documented cardiac amyloidosis and atrial fibrillation or flutter undergoing this imaging procedure. During the trial, participants will have cardiac PET/MRI scans after tracer injection, with data collected to evaluate the presence of thrombi. The primary outcome is the detection of intracardiac thrombus within one day of imaging. Researchers will also assess heart function and amyloid levels. Safety and ability to complete the imaging procedure will be monitored. Participants' involvement includes consent, undergoing imaging, and review of recent TEE results over the study period.

Researchers are investigating acute myocardial inflammation, a complex condition that includes acute cellular cardiac allograft rejection (ACR), cardiac sarcoidosis (CS), and immune checkpoint inhibitor induced myocarditis (ICIM). This study aims to evaluate the accuracy of [68Ga]Ga-PentixaFor PET/CT imaging for detecting inflammatory cells in these patients, offering a potentially non-invasive diagnostic option. The study is a phase 2 trial focusing on these specific heart inflammation conditions where diagnosis is currently challenging. Participants will receive an intravenous injection of a maximum of 50 micrograms of PentixaFor labeled with 150 ±15 MBq of Gallium-68 ([68Ga]) as a bolus 60 ±15 minutes before undergoing PET/CT imaging. The treatment involves this imaging procedure for all three patient groups (ACR, CS, ICIM) to assess the presence and characteristics of myocardial inflammation. During the study, researchers will evaluate imaging results by analyzing lesion number, location, and standardized uptake value (SUV) over one year. They will also monitor toxicity data for safety assessment. Participants will have regular clinical follow-ups at the cardiology department. The study involves signing informed consent and includes monitoring for any adverse effects related to the imaging agent or procedures throughout the study duration.

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 effects of a sequential "lying-sitting-standing" Baduanjin exercise on patients who have acute coronary syndrome complicated by heart failure. The study aims to compare this intervention with conventional treatment by assessing heart and lung function as well as quality of life. Key measures include echocardiography, NT-proBNP levels, a six-minute walk test, NYHA classification, and the SF-36 health survey, with the goal of improving early cardiac rehabilitation strategies for these patients. Participants will be randomly assigned to either receive standard treatment with routine rehabilitation nursing guidance or to practice the "lying-sitting-standing" sequential Baduanjin exercise. The intervention lasts 12 weeks, during which researchers will monitor several health indicators and functional assessments. This double-blind study compares these two behavioral approaches to determine their impact on cardiopulmonary function and patient well-being. During the 12-week treatment, participants will undergo evaluations including the six-minute walk test, assessment of heart function by echocardiography, measurement of blood markers such as NT-proBNP and C-reactive protein, and quality of life surveys like the SF-36. Additional assessments include flow-mediated vasodilation and activities of daily living scales. These tests will help researchers measure changes in heart function, physical ability, and overall health status throughout the study period.

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.