Cardiomyopathy

Researchers are evaluating the radiopharmaceutical 18F-meta-fluorobenzylguanidine 18F-mFBG as a new imaging agent to measure myocardial sympathetic innervation in stable patients with heart failure due to ischemic cardiomyopathy. This Phase 2 study focuses on adults who have a left ventricular ejection fraction of 35% or less and have implantable cardioverter-defibrillators ICDs. The study aims to compare 18F-mFBG uptake with historical imaging agents and assess differences in sympathetic innervation related to past ICD activations. Participants will receive two PET radiopharmaceuticals intravenously 18F-mFBG to assess sympathetic innervation and Rubidium-82 to assess myocardial blood flow. The study groups consist of patients who have experienced ICD activation within the past 12 months and those who have not. Both imaging agents will be used to examine cardiac regions for abnormalities and to quantify myocardial uptake patterns during the study. During the trial, participants will undergo PET imaging and safety monitoring for 24 hours after the administration of these agents. Researchers will collect imaging data, evaluate heart function, and monitor for any adverse or serious adverse events. The study will assess how well 18F-mFBG works compared to previous imaging methods and gather safety information over the course of participation.

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 tomographycomputed tomography 68Ga-FAPI PETCT 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 PETCT 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 18FFT8, a diagnostic imaging agent, for detecting amyloidosis, including cardiac amyloidosis. This study aims to assess the safety and effectiveness of 18FFT8 PETCT 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 18FFT8, followed by a PETCT 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 PETCT scan. Researchers will monitor safety from the time of injection up to seven days afterward, and evaluate organ uptake and biodistribution of 18FFT8 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 a new imaging technique using 64CuFBP8, a novel fibrin-binding PET probe combined with simultaneous cardiac PETMRI, 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 the imaging can identify clots in over 90% of patients who have confirmed clots based on a standard transesophageal echocardiogram TEE. Secondary analyses will explore how these clots relate to heart function and amyloid build-up in the left ventricle. Participants will receive an injection of 64CuFBP8 followed by simultaneous cardiac PETMR imaging. The study involves twenty individuals with documented cardiac amyloidosis and atrial fibrillation or flutter. The imaging is performed once, and results will be compared to recent or upcoming TEE tests to confirm the presence of clots. This study focuses on evaluating the diagnostic value of this new PETMRI method in detecting intracardiac thrombi. During the study, participants will undergo PETMR imaging after receiving the tracer injection. The main outcome measured is the detection of intracardiac thrombus within one day of imaging. The researchers will also assess associations between clots and heart function or amyloid burden. Participants will be monitored for eligibility and safety, including assessments of their ability to undergo imaging and recent heart evaluations. The study is expected to last from July 2026 to March 2027, with diagnostic imaging as the key procedure.

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 68GaGa-PentixaFor PETCT 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 PETCT 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 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 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.