[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Heart Center Leipzig - University Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":107},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,42,64,87],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100628514","repeat-intervention-for-failed-surgical-bioprosthetic-aortic-valves-repeat-100628514",false,"NCT07462624","REpeat Intervention For Failed Surgical BioProsthEtic AorTic Valves (REPEAT)","REpeat Intervention for Failed Surgical BioProsthEtic AorTic Valves (REPEAT): A Multicenter Randomized Trial Comparing Redo Surgical Aortic Valve Replacement to Valve-in-Valve Transcatheter Aortic Valve Replacement","REPEAT","Inclusion Criteria:\n\n* Indication for repeat intervention for failed surgical aortic bioprosthesis due to structural valve deterioration (SVD; prosthesis stenosis and\u002For transprosthetic insufficiency);\n* Low to intermediate surgical risk (i.e., Society of Thoracic Surgeons (STS) predicted risk of mortality of \\\u003C 8%);\n* Age \\> 18 and \\\u003C 75 years;\n* Both rAVR and ViV-TAVR are judged to be reasonable options based on evaluation by the local Heart Team\n\nExclusion Criteria:\n\n* Multiple valvular disease requiring surgical intervention;\n* High-risk coronary anatomy resulting in increased risk of coronary obstruction following ViV-TAVR prosthesis deployment;\n* Complex coronary artery disease requiring revascularization (unprotected left main coronary artery, Syntax score \\> 32) and Heart Team assessment that optimal revascularization cannot be performed;\n* Failing valve with evidence of bacterial endocarditis or evidence of non-structural valve deterioration (e.g., paravalvular leak, thrombosis);\n* Increased post-procedural gradients (mean \\> 20 mmHg) or severe patient-prosthesis mismatch (PPM, indexed effective orifice area \\\u003C 0.65 cm2\u002Fm2) at discharge from index aortic valve replacement (AVR) procedure;\n* Patients who choose to receive a mechanical AVR.","ALL","18 Years","75 Years",{"count":21,"type":22},890,"ESTIMATED","INTERVENTIONAL",[25],"NA","The overall hypothesis is that redo aortic valve replacement (rAVR) is superior to valve-invalve transcatheter aortic valve replacement (ViV-TAVR) for the composite endpoint of freedom from all-cause mortality, all-cause stroke, myocardial infarction, and rehospitalization for heart failure or aortic valve re-intervention at 5 years.",[28],"Degenerative Aortic Valve Disease","RECRUITING","2026-03-05",{"date":32,"type":33},"2026-03-10","ACTUAL",{"date":35,"type":33},"2025-11-10",{"date":37,"type":22},"2033-09-30",{"name":39,"class":40},"Heart Center Leipzig - University Hospital","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":23,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":63},"100581074","prediction-of-blood-pressure-outcomes-following-renal-denervation-predict-rdn-100581074","NCT06845579","Prediction of Blood Pressure Outcomes Following Renal Denervation (PREDICT-RDN)","PREDICT-RDN","Inclusion Criteria:\n\n1. Confirmed arterial hypertension with systolic or diastolic blood pressure \\>140\u002F90 mmHg in standardized office blood pressure measurement\n2. Treatment with 3 to ≤5 antihypertensive drug classes\n3. Age \\>18 years\n4. Written informed consent\n\nExclusion Criteria:\n\n1. Age ≤ 18 years\n2. anatomy unsuitable for renal denervation (i.e. renal artery stenosis, single functioning kidney)\n3. pregnancy\n4. patients under legal supervision or guardianship\n5. participation in other trials that might interfere with the study outcome according to the opinion of one of the investigators.",{"count":50,"type":22},90,[25],"Prospective, single arm trial to assess the effects of renal denervation on day-by-day blood pressure measurements and time in blood pressure target range, as well as establish a multivariate prediction model for blood pressure reduction after renal denervation.",[54],"Uncontrolled Arterial Hypertension","2025-06-23",{"date":57,"type":33},"2025-06-24",{"date":59,"type":33},"2025-06-01",{"date":61,"type":22},"2028-02-29",{"name":39,"class":40},2,{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":72,"targetDuration":74,"studyType":75,"phases":4,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":41},"100419099","diagnostic-criteria-in-cardiac-sarcoidosis-100419099","NCT04737317","Diagnostic Criteria in Cardiac Sarcoidosis","Evaluation of Diagnostic Criteria in Cardiac Sarcoidosis - an Observational Study","ELDORADO","Inclusion Criteria:\n\n* patients with suspected CS due to the following presentations:\n\n  1. age \\\u003C 65 years and new higher degree AV block, causative coronary artery disease excluded\n  2. age \\\u003C 65 years and new ventricular tachycardia, causative coronary artery disease excluded\n  3. age \\\u003C 65 years and ventricular tachycardia, causative coronary artery disease excluded\n  4. extracardiac sarcoidosis and cardiac involvement suggested (palpitations, abnormal ECG, abnormal echocardiography)\n\nTo diagnose CS one of the following diagnostic tools will be used:\n\nA) World Association of Sarcoidosis and Other Granulomatous Disorders (WASOG)\n\nB) Heart Rhythm Society expert consensus statement on the diagnosis and management of arrhythmias associated with cardiac sarcoidosis\n\nC) Japanese Society of Nuclear Cardiology (JSNC)\n\nPatients whit histological confirmation from myocardial tissue fullfil will be defined as proven CS. (Group 1)\n\nPatients with clinical and imaging findings highly suggesting CS, but without histological confirmation from myocardial biopsy will be defined as probable CS (Group 2)\n\nPatients who do not fullfil the criteria or exhibiting findings suggesting an alternative, more likely diagnosis, will be considered as unlikely CS (Group 3)\n\nExclusion Criteria:\n\n* unable or unwilling to provide informed consent\n* patients who are pregnant or lactating\n* noncompliant patients refusing the recommended therapy\n* age \\\u003C 18 years",{"count":73,"type":22},100,"2 Years","OBSERVATIONAL","The purpose of the study is to evaluate the accuracy of the current diagnostic criteria of cardiac sarcoidosis.",[78],"Cardiac Sarcoidosis","2023-05-08",{"date":81,"type":33},"2023-05-09",{"date":83,"type":33},"2023-05-01",{"date":85,"type":22},"2027-01-01",{"name":39,"class":40},{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":94,"targetDuration":95,"studyType":75,"phases":4,"briefSummary":96,"conditions":97,"keywords":4,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":4},"100500218","biomaterial-collection---and-analysis-in-cardiac-sarcoidosis-100500218","NCT05793398","Biomaterial Collection - and Analysis in Cardiac Sarcoidosis","Pathomechanisms in Patients With Cardiac Sarcoidosis and Other Inflammatory and Familial Cardiomyopathies of Similar Phenotypic Appearance","Inclusion Criteria:\n\n(a) patients with a history of symptomatic cardiac sarcoidosis\u002Finflammatory cardiomyopathy or b) patients with newly diagnosed heart failure with cardiac arrhythmias (ventricular tachycardia, conduction disturbances, etc.) that may indicate sarcoidosis or inflammatory cardiomyopathy or c) patients with image morphological suspicion of cardiac sarcoidosis or inflammatory cardiomyopathy (MRI, PET-CT) or (d) patients who require or have received a ventricular assist device (VAD) or cardiac transplantation due to suspected cardiac sarcoidosis or inflammatory cardiomyopathy and (e) written informed consent has been obtained from patients for study participation and consent for analysis of patient samples. Studies on pseudoanonymized samples will only be performed with appropriately signed informed consent.\n\nExclusion Criteria:\n\n1. Patients with psychiatric illness that impairs business or insight capacity.\n2. Patients with chronic heart failure due to coronary artery disease or valvular vitiation.\n3. severe underlying disease other than sarcoidosis that is likely to result in death within one year.",{"count":73,"type":22},"5 Years","Cardiac sarcoidosis (CS) is a complex disease that is characterized by the formation of inflammatory granulomas in the myocardium. The exact underlying pathophysiology of the disease is not yet fully understood, but it is believed to be related to dysregulation of the immune system. Despite significant progress in recent years, the disease remains difficult to diagnose, and there is a high risk of severe complications such as life-threatening cardiac arrhythmias, severe heart failure, and sudden cardiac death in affected patients.\n\nMoreover, the clinical presentation of CS can be similar to other inflammatory heart diseases or familial cardiomyopathies. Thus, it is challenging to differentiate between these diseases, which can lead to a delayed diagnosis and poor prognosis. It is unclear whether certain genetic variants play a role in the clinical course and prognosis of CS, which highlights the need for more research in this area.\n\nThe diagnosis of CS requires cardiac or extracardiac biopsy with granuloma detection, which is an invasive and complex procedure. Consequently, the disease is thought to be underdiagnosed, and many affected patients may not receive timely treatment, resulting in excess mortality. Early diagnosis and immunosuppressive treatment, as well as defibrillator implantation if necessary, are crucial in delaying disease progression, preventing complications, and improving prognosis.\n\nTo better understand the key molecular pathological mechanisms underlying the development and maintenance of CS, a prospective, multicenter, exploratory study has been initiated. The project involves the collection, storage, and analysis of biological samples from blood, myocardium, and lymph nodes of patients with cardiac sarcoidosis or cardiomyopathies that present clinically and image morphologically similar. The samples will be used for scientific investigations on disease mechanisms of cardiomyopathies as well as for identification of new biomarkers in cardiomyopathy diagnostics and for follow-up of therapeutic measures.\n\nThe study will employ a range of classical biochemical methods such as ELISA, RIA, as well as more modern methods of molecular biology (single cell sequencing, single nucleus sequencing) and systems biology (genomics, metabolomics, or proteomics) to identify key molecular pathological mechanisms in the development and maintenance of CS.\n\nIn addition, genetic analysis will be performed to investigate cardiomyopathy- and ion channel-associated genetic variants, which is critical for improving diagnostics and early, individualized therapy. The study will be conducted on a multicenter basis, with the Heart Center Leipzig serving as the initiator and lead center and the University Hospital Leipzig as the second study center. Biochemical and molecular biological analyses will be performed on behalf of the study management at the Heart Center Leipzig, the University Hospital Leipzig, and the Erich and Hanna Klessmann Institute for Cardiovascular Research and Development of the Heart and Diabetes Center NRW and Max Delbrück Center for Molecular Medicine in Berlin.\n\nIn conclusion, CS is a complex and challenging disease that requires further research to better understand its underlying mechanisms and improve diagnostic and therapeutic strategies. The prospective, multicenter, exploratory study will provide valuable insights into the disease's key molecular pathological mechanisms and identify new biomarkers for better diagnostics and individualized therapy.",[78],"NOT_YET_RECRUITING","2023-03-30",{"date":101,"type":33},"2023-03-31",{"date":103,"type":22},"2023-04-01",{"date":105,"type":22},"2029-04-01",{"name":39,"class":40},""]