[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"arrhythmogenic-right-ventricular-cardiomyopathy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:arrhythmogenic-right-ventricular-cardiomyopathy":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,49,83,118,144,169,205,235,258],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":16,"targetDuration":4,"studyType":19,"phases":4,"briefSummary":20,"conditions":21,"keywords":28,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100242269","pediatric-cardiomyopathy-mutation-analysis-100242269",false,"NCT02432092","Pediatric Cardiomyopathy Mutation Analysis","Inclusion Criteria:\n\n* Subjects with cardiomyopathy\n* Family members of subjects with cardiomyopathy\n\nExclusion Criteria:\n\n* Subjects without cardiomyopathy\n* Family members of subjects without cardiomyopathy","ALL",{"count":17,"type":18},300,"ESTIMATED","OBSERVATIONAL","The goal of this protocol is to obtain information from individuals with cardiomyopathy and from their families in order to elucidate the molecular genetics of this disorder. This will provide the basis for future genetic counseling as well as contribute to elucidating the biology of normal and abnormal cardiac function.",[22,23,24,25,26,27],"Cardiomyopathies","Dilated Cardiomyopathy","Hypertrophic Cardiomyopathy","Restrictive Cardiomyopathy","Arrhythmogenic Right Ventricular Cardiomyopathy","Left Ventricular Non-compaction Cardiomyopathy",[29,30,31,32,33,34,35],"Cardiomegaly","Cardiovascular Diseases","Heart Diseases","Systolic dysfunction","Diastolic dysfunction","Ventricular hypertrophy","Heart failure","RECRUITING","2026-06-17",{"date":39,"type":40},"2026-06-22","ACTUAL",{"date":42,"type":4},"2014-04",{"date":44,"type":18},"2030-12-31",{"name":46,"class":47},"Indiana University","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":15,"minAge":57,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":67,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":48},"100636282","fapi-petct-imaging-in-arrhythmogenic-right-ventricular-cardiomyopathy-arvc-fapi-arvc-100636282","NCT07563660","FAPI PET\u002FCT Imaging in Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC) (FAPI-ARVC))","Incremental Diagnostic and Prognostic Value of 68Ga-DOTA-SA-FAPI PET\u002FCT Imaging in Patients With Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)","FAPI-ARVC","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Established diagnosis of arrhythmogenic right ventricular cardiomyopathy according to the 2010 Revised Task Force Criteria and\u002For the Padua criteria\n* Under active follow-up at the study center\n* Ability to understand the study procedures and provide written informed consent\n\nExclusion Criteria:\n\n* History of malignancy\n* Severe renal impairment\n* Severe hepatic impairment\n* Pregnancy or breastfeeding\n* Prior 68Ga-DOTA-SA-FAPI PET\u002FCT imaging\n* Inability or unwillingness to provide written informed consent\n* Any medical, clinical, or logistical condition that, in the opinion of the investigators, could interfere with study participation, image interpretation, or completion of follow-up","18 Years",{"count":59,"type":18},15,"INTERVENTIONAL",[62],"NA","Arrhythmogenic right ventricular cardiomyopathy (ARVC) is an inherited heart muscle disease associated with fibrofatty myocardial replacement, ventricular arrhythmias, and an increased risk of sudden cardiac death. Although current diagnostic approaches, including the 2010 Task Force Criteria and the Padua criteria, improve recognition of the disease, early diagnosis remains challenging, particularly when structural abnormalities are subtle or absent on conventional imaging. Echocardiography and cardiac magnetic resonance imaging are central to evaluation, but their sensitivity for early or active fibrotic remodeling may be limited. This limitation may be particularly relevant in patients who are unable to undergo cardiac magnetic resonance imaging, in whom 68Ga-DOTA-SA-FAPI PET\u002FCT may provide complementary diagnostic information.\n\nThis prospective single-group diagnostic imaging study aims to investigate the incremental value of protocol-specified 68Ga-DOTA-SA-FAPI PET\u002FCT imaging in patients with ARVC. FAPI PET\u002FCT is a novel molecular imaging method that targets activated fibroblasts and may allow non-invasive detection of active myocardial fibrosis.Fifteen adult patients with an established diagnosis of ARVC will undergo protocol-specified 68Ga-DOTA-SA-FAPI PET\u002FCT imaging in addition to clinical evaluation, electrocardiography, echocardiography, and review of previously obtained cardiac magnetic resonance imaging findings. FAPI PET\u002FCT findings will be compared with conventional diagnostic criteria and other clinical and imaging parameters, including previously available cardiac magnetic resonance imaging findings. Participants will also be followed clinically for 6 months after imaging to explore possible associations between FAPI uptake and short-term clinical outcomes, including arrhythmic events, ventricular function, and laboratory markers.\n\nThe study is expected to provide preliminary evidence on whether 68Ga-DOTA-SA-FAPI PET\u002FCT may improve the detection of myocardial fibrosis and contribute to diagnostic assessment and risk stratification in ARVC. It may also help clarify the potential role of FAPI PET\u002FCT in patients who are unable to undergo cardiac magnetic resonance imaging. The findings may support future larger prospective studies in this field.",[26,65,66],"FAPI PET","Cardiac Magnetic Resonance Imaging",[26,68,69,70,71,72,66,73],"Fibroblast Activation Protein","Positron Emission Tomography Computed Tomography","Molecular Cardiac Imaging","Sudden Cardiac Death Risk Stratification","Inherited Cardiomyopathy","Myocardial Fibrosis","2026-04-30",{"date":76,"type":40},"2026-05-04",{"date":78,"type":40},"2025-04-16",{"date":80,"type":18},"2026-10-26",{"name":82,"class":47},"Istanbul University - Cerrahpasa",{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":90,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":19,"phases":4,"briefSummary":93,"conditions":94,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":117},"100289553","mayo-avc-registry-and-biobank-100289553","NCT03049254","Mayo AVC Registry and Biobank","Identification of Novel Genetic Variants and Biomarkers of Disease Progression in Arrhythmogenic Cardiomyopathy","Inclusion Criteria:\n\n* Patients with a diagnosis of a non-MI SCA who survived\n* Patients with a non-MI SCD\n* Patient with a SCA associated with seizures, epilepsy, syncope, drowning and near-drowning, where a cardiomyopathy is suspected\n* Family member of a patient diagnosed with primary cardiomyopathy (including HCM, idiopathic DCM, AVC)\n\nExclusion Criteria:\n\n* Patients with a clear, unambiguous known cause of SCA or SCD such as myocardial infarction or heart failure secondary to ischemic heart disease\n* Significant coronary artery disease (Epicardial coronary artery stenosis \\>50%) which can explain degree of LV dysfunction\n* Those unwilling to provide written consent or assent",true,{"count":92,"type":18},1000,"Arrhythmogenic ventricular cardiomyopathy (AVC) is a genetic condition which affects the heart and can lead to heart failure and rhythm problems, of which, sudden cardiac arrest or death is the most tragic and dangerous. Diagnosis and screening of blood-relatives is very difficult as the disease process can be subtle, but sufficient enough, so that the first event is sudden death.\n\nThe Mayo Clinic AVC Registry is a collaboration between Mayo Clinic, Rochester, USA and Papworth Hospital, Cambridge University Hospitals, Cambridge, UK. The investigators aim to enroll patients with a history of AVC or sudden cardiac death which may be due to AVC, from the US and UK. Family members who are blood-relatives will also be invited, including those who do not have the condition. Data collected include symptoms, ECG, echocardiographic, MRI, Holter, loop recorder, biopsies, exercise stress testing, blood, buccal and saliva samples.\n\nObjectives of the study:\n\n1. Discover new genes or altered genes (variants) which cause AVC\n2. Identify biomarkers which predict (2a) disease onset, (2b) disease progression, (2c) and the likelihood of arrhythmia (ventricular, supra-ventricular and atrial fibrillation)\n3. Correlate genotype with phenotype in confirmed cases of AVC followed longitudinally using clinical, electrocardiographic and imaging data.\n4. Characterize desmosomal changes in buccal mucosal cells with genotype and validate with gold-standard endomyocardial biopsies",[26,22,31,30,95,96,97,98,99,100,101,102,103,104,105,106,107],"Sudden Cardiac Arrest","Sudden Cardiac Death","Arrhythmogenic Right Ventricular Dysplasia","Arrhythmogenic Ventricular Cardiomyopathy","Familial Dilated Cardiomyopathy","Cardiovascular Abnormalities","Sarcoidosis","Cardiac Arrhythmia","Cardiac Sarcoidosis","Myocarditis","Inflammatory Cardiomyopathy","Ventricular Tachycardia","Right Ventricular Outflow Tract Ventricular Tachycardia","2026-04-22",{"date":110,"type":40},"2026-04-27",{"date":112,"type":40},"2018-02-09",{"date":114,"type":18},"2027-03",{"name":116,"class":47},"Mayo Clinic",2,{"id":119,"slug":120,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":4,"eligibilityCriteria":124,"healthyVolunteers":90,"sex":15,"minAge":125,"maxAge":4,"enrollmentInfo":126,"targetDuration":4,"studyType":60,"phases":128,"briefSummary":129,"conditions":130,"keywords":131,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":48},"100519184","arrhythmogenic-activity-during-exercise-in-arvc-patients-100519184","NCT06040242","Arrhythmogenic Activity During Exercise in ARVC Patients","Characterization of Arrhythmogenic Activity During and After Physical Exercise in Patients With Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)","Inclusion Criteria:\n\n* Definitive ARVC diagnosis according to the modified 2010 ARVC Task Force Criteria\n* Pathogenic \u002F likely pathogenic variant in one of the following desmosomal genes: plakophilin-2 (PKP-2), desmoglein-2 (DSG-2) or desmoplakin (DSP) or gene-elusive definite ARVC (i.e., genetic test performed but no pathogenic \u002F likely pathogenic variant found)\n* Control group: diagnosed ischemic heart disease with ejection fraction above 35%\n* Agreement with responsible primary cardiologist that study participation is not considered beyond acceptable levels of physical activity for this particular patient\n* No history of exercise-induced syncope in the 6 months prior to study participation\n* No history of sudden cardiac arrest in the 6 months prior to study participation\n* In patients who suffered from sudden cardiac arrest\u002Farrhythmic syncope, only those having an implantable cardioverter-defibrillator (ICD) and being under beta-blockers\u002Fantiarrhythmic drugs are eligible for study inclusion\n* Informed Consent as documented by signature (Appendix Informed Consent Form)\n* Age: \\> 14 years\n* Body-Mass-Index (BMI): 18.5 - 39.9 kg･m-2\n* Willing to adhere to the following study rules:\n\n  * No intense exercise 48h prior to testing\n  * No exercise 24h prior to testing\n  * Sleep at least 7h the two nights before testing On test day\n  * No caffeinated food or drink before testing on test day\n  * No alcohol before testing on test day\n  * Fully compliant with normal medication regimen including beta-blockers and antiarrhythmic medication\n\nExclusion Criteria:\n\n* No genetic test history for ARVC variants\n* Heart failure with severely reduced left ventricular ejection fraction (LVEF \\\u003C35%)\n* For women: Pregnancy, breastfeeding, or intention to become pregnant during the study.\n* Known or suspected non-compliance, drug, or alcohol abuse\n* Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, etc. of the participant\n* Previous enrolment into the current study","14 Years",{"count":127,"type":18},120,[62],"Current guidelines advocate that ARVC patients, typically young and active individuals with a significant history of competitive endurance sports, cease endurance training in favour of activities with low cardiac burden such as bowling and golf. Empirically, it is often suggested that heart rate during exercise should not exceed 100-120 bpm in these patients, but these guidelines are arbitrary and not scientifically based. In practice, it is estimated that up to 50% of patients do not comply with these recommendations .\n\nAdequate quantification of the arrhythmogenic burden, defined as premature ventricular beats in proportion to all heart beats in each period of time, and cardiac load (defined as stroke volume for volume load and systolic blood pressure for pressure load) experienced by ARVC patients when performing different types of physical exercise would be a first step towards designing a safe and effective intervention so that these patients can profit from an active life style.\n\nThis study therefore aims to quantify and describe the arrhythmogenic burden and cardiac load experienced by patients with ARVC while performing different physical exercise over a range of intensities - all strictly within the range currently recommended by different cardiological societies.",[26],[132,133,134],"exercise","cycling","physical activity","2026-03-19",{"date":137,"type":40},"2026-03-24",{"date":139,"type":40},"2023-08-01",{"date":141,"type":18},"2027-12-31",{"name":143,"class":47},"Swiss Federal Institute of Technology",{"id":145,"slug":146,"hasResults":11,"nctId":147,"briefTitle":148,"officialTitle":148,"acronym":149,"eligibilityCriteria":150,"healthyVolunteers":11,"sex":15,"minAge":57,"maxAge":4,"enrollmentInfo":151,"targetDuration":4,"studyType":60,"phases":152,"briefSummary":154,"conditions":155,"keywords":157,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":168},"100529472","phase-2-targeted-therapy-with-glycogen-synthase-kinase-3-inhibition-for-arrhythmogenic-cardiomyopathy-100529472","NCT06174220","Targeted Therapy With Glycogen Synthase Kinase-3 Inhibition for Arrhythmogenic Cardiomyopathy","TaRGET","Inclusion Criteria:\n\n* A pathogenic or likely pathogenic desmosomal (PKP2, DSG2, DSC2, DSP, or JUP\\*) rare variant OR the TMEM43-p.S358L variant\n\n  \\*JUP carriers must be homozygous or compound heterozygous\n* Mean ≥ 500 PVCs per 24 hours on a baseline screening 7-day Holter monitor\n* Clinical ACM diagnosis or recognition of genetic carrier status for ≥ 6 months prior to screening\n\nExclusion Criteria:\n\n* NYHA class IV heart failure\n* Ventricular scar secondary to coronary artery disease\n* Initiation, cessation, or dose change of a Class I or III anti-arrhythmic drug in the 3 months prior to screening\n* Any potentially harmful chronic liver disease\n* ALT value \\> 2X the upper limit of the normal reference range at Screening\n* Total bilirubin value greater than the upper limit of the normal reference range at Screening, unless documented Gilbert's syndrome. For individuals with Gilbert's syndrome, total bilirubin value greater than 2-fold the upper limit of the normal reference range at Screening.\n* A history of alcohol or illicit substance use disorders\n* Regular and long-term use of strong CYP3A4 inhibitors, including clarithromycin, telithromycin, ketoconazole, itraconazole, posaconazole, nefazodone, idinavir and ritonavir\n* Serum creatinine \\> 150 micromole\u002FL or creatinine clearance ≤ 60 mL\u002Fmin (according to Cockcroft-Gault formula) at Screening\n* Pregnant at time of enrollment and women of childbearing age who do not use a highly effective form of contraception\n* Males, engaged in sexual relations with a female of child-bearing potential, not using an acceptable contraceptive method if not surgically sterile\n* Patients unwilling to provide informed consent or comply with follow-up\n* Hypersensitivity to tideglusib or any components of its formulation, including allergy to strawberry\n* Concurrent use of drugs metabolized by CYP3A4 with a narrow therapeutic window e.g. warfarin and digoxin",{"count":127,"type":18},[153],"PHASE2","The TaRGET study is a multi-centre, prospective, randomized, double-blind, placebo-controlled trial designed to evaluate the potential therapeutic efficacy of tideglusib, a glycogen synthase kinase-3 β inhibitor, in genotype positive arrhythmogenic cardiomyopathy.",[156,26],"Arrhythmogenic Cardiomyopathy",[158],"sudden cardiac death, ventricular cardiomyopathy, genetics, arrhythmia","2026-03-10",{"date":161,"type":40},"2026-03-12",{"date":163,"type":40},"2025-03-21",{"date":165,"type":18},"2027-07-01",{"name":167,"class":47},"Hamilton Health Sciences Corporation",17,{"id":170,"slug":171,"hasResults":11,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":175,"eligibilityCriteria":176,"healthyVolunteers":11,"sex":15,"minAge":57,"maxAge":177,"enrollmentInfo":178,"targetDuration":4,"studyType":60,"phases":179,"briefSummary":181,"conditions":182,"keywords":183,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":204},"100533677","phase-1-open-label-dose-escalation-study-of-safety-and-preliminary-efficacy-of-tn-401-in-adults-with-pkp2-mutation-associated-arvc-100533677","NCT06228924","Open-label, Dose Escalation Study of Safety and Preliminary Efficacy of TN-401 in Adults With PKP2 Mutation-associated ARVC","First-in-Human, Open-Label, Safety, Tolerability, Dose-Finding, Pharmacodynamic and Cardiac Transgene Expression Study of TN-401, a Recombinant Adeno-associated Virus Serotype 9 (AAV9) Containing Plakophilin-2 (PKP2) Transgene, in Adults With PKP2 Mutation-Associated Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)","RIDGE-1","Inclusion Criteria:\n\n* PKP2 mutation (pathogenic or likely pathogenic)\n* Arrhythmogenic Right Ventricular Cardiomyopathy as defined by the 2010 revised Task Force Criteria\n* Left Ventricular Ejection Fraction ≥50%\n* Functioning Implantable Cardiac Defibrillator with remote integration capabilities at least 9 months prior to Screening\n* NYHA Functional Class I, II, or III\n* Frequent premature ventricular contractions (PVCs)\n\nExclusion Criteria:\n\n* Ventricular tachycardia (VT) ablation within 6 months of Screening or planned VT ablation within 6 months after Screening\n* High AAV9 neutralizing antibody titer\n* Prior myocardial infarction\n* Right Ventricular Heart Failure\n* Class IV Heart Failure\n* Clinically significant renal disease\n* Clinically significant liver disease","65 Years",{"count":59,"type":18},[180],"PHASE1","This first-in-human study is designed to evaluate the safety, and preliminary efficacy (PD) of TN-401 gene therapy in adult patients with symptomatic PKP2 mutation-associated ARVC.",[26],[184,185,186,187,188,189,190,191,192,193],"PKP2 Mutation Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)","Arrhythmogenic Cardiomyopathy (ACM)","PKP2-associated ARVC","PKP2-ARVC","PKP2-ACM","Adeno Associated Virus (AAV)","Gene Therapy","Gene Transfer","Genetic cardiomyopathy","Heart Failure","2025-02-05",{"date":196,"type":40},"2025-02-06",{"date":198,"type":40},"2024-03-26",{"date":200,"type":18},"2029-10-01",{"name":202,"class":203},"Tenaya Therapeutics","INDUSTRY",7,{"id":206,"slug":207,"hasResults":11,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":211,"eligibilityCriteria":212,"healthyVolunteers":90,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":213,"targetDuration":4,"studyType":19,"phases":4,"briefSummary":215,"conditions":216,"keywords":221,"overallStatus":225,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":4},"100573590","ai-enabled-screening-and-diagnosis-of-cardiomyopathies-using-coronary-cta-100573590","NCT06748261","AI-enabled Screening and Diagnosis of Cardiomyopathies Using Coronary CTA","Artificial Intelligence-enabled Screening and Diagnosis of Cardiomyopathies Using Coronary Computer Tomography Angiography","Atlantis","Cardiomyopathy cohort:\n\n* Inclusion Criteria:\n\n  1. A clinical diagnosis of cardiomyopathies, including hypertrophic cardiomyopathy, dilated cardiomyopathy, restrictive cardiomyopathy, cardiac amyloidosis, myocarditis, arrhythmogenic right ventricular cardiomyopathy, and coronary artery disease\u002Fischemic heart disease.\n  2. At least one CCTA before surgery or implantable device treatment.\n* Exclusion Criteria:\n\n  1. No recorded diagnosis of cardiomyopathy or undetermined type of cardiomyopathy.\n  2. A clinical diagnosis of secondary cardiac abnormalities due to other organic or systemic diseases.\n  3. Surgery or implantable device treatment before CCTA examination.\n\nControl cohort:\n\n* Inclusion Criteria: participants with at least one CCTA examination.\n* Exclusion Criteria: clinical diagnosis of cardiovascular diseases (including cardiomyopathy, history of myocardial infarction, history of cardiac surgery, stent implantation, ICD implantation and so on) or secondary cardiac abnormalities due to systemic diseases.",{"count":214,"type":18},5000,"The goal of this observational and diagnostic study is to develop and validate an artificial intelligence assisted approach for coronary computer tomography angiography-(CCTA)-based screening and diagnosis of cardiomyopathies in patients with suspected coronary artery diseases. This study aims to develop a computerized CCTA interpretation using artificial intelligence for multi-label classification task to assist cardiomyopathy diagnosis in the clinical workflow.",[30,217,218,25,219,220,26,104,22],"Hypertrophic Cardiomyopathy (HCM)","Dilated Cardiomyopathy (DCM)","Amyloid Cardiomyopathy","Ischemic Cardiomyopathy",[222,22,223,224],"Cardiac computer tomography angiography","Artificial intelligence","Diagnosis","NOT_YET_RECRUITING","2024-12-23",{"date":228,"type":40},"2024-12-27",{"date":230,"type":18},"2024-12-30",{"date":232,"type":18},"2025-12-30",{"name":234,"class":47},"Shanghai Zhongshan Hospital",{"id":236,"slug":237,"hasResults":11,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":241,"eligibilityCriteria":242,"healthyVolunteers":11,"sex":15,"minAge":125,"maxAge":177,"enrollmentInfo":243,"targetDuration":4,"studyType":19,"phases":4,"briefSummary":245,"conditions":246,"keywords":247,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":257},"100540043","non-interventional-study-of-seroprevalence-of-pre-existing-antibodies-against-adenovirus-associated-virus-vector-aav9-and-the-progression-of-disease-in-patients-with-plakophilin-2-pkp2-associated-arrhythmogenic-right-ventricular-cardiomyopathy-arvc-100540043","NCT06311708","Non-interventional Study of Seroprevalence of Pre-existing Antibodies Against Adenovirus-associated Virus Vector (AAV9) and the Progression of Disease in Patients With Plakophilin 2 (PKP2)-Associated Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)","Seroprevalence Study of Pre-existing Antibodies Against Adenovirus-associated Virus Vector (AAV9) in Patients With Plakophilin 2 (PKP2)-Associated Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC)","RIDGE","Inclusion Criteria:\n\n* Ages 14-65 years, inclusive, at the time of consent\n* Pathogenic or likely pathogenic PKP2 gene mutation\n* Diagnosed with ARVC and meet 2010 Modified Task Force Criteria for ARVC as affected.\n* Functioning ICD\n\nExclusion Criteria:\n\n* Currently receiving systemic immunosuppressive therapy, cytotoxic chemotherapy, immunoglobulin therapy or monoclonal antibody therapy\n* History of clinically significant liver disease, hepatitis B virus, hepatitis C virus, human immunodeficiency virus, or tuberculosis infection\n* Previously dosed with any investigational or approved gene therapy product at any time\n* Concurrent participation in another interventional clinical trial unless approved by the Sponsor. Participation in a noninterventional study may be allowed at the investigator's discretion.\n* History of cardiac transplant.",{"count":244,"type":18},200,"This is a multicenter, non-interventional study to observe the natural progression of the disease and to study the prevalence of pre-existing antibodies to AAV9 used for gene therapy in a population of patients with PKP2 gene-associated ARVC. Participation from all patients is encouraged regardless of interest in or eligibility for gene therapy.",[26],[184,185,186,187,188,189,248,190,191,192,193],"Adeno-Associated Virus Serotype 9 (AAV9)","2024-10-30",{"date":251,"type":40},"2024-11-01",{"date":253,"type":40},"2023-01-31",{"date":255,"type":18},"2030-07-11",{"name":202,"class":203},21,{"id":259,"slug":260,"hasResults":11,"nctId":261,"briefTitle":262,"officialTitle":263,"acronym":264,"eligibilityCriteria":265,"healthyVolunteers":11,"sex":15,"minAge":57,"maxAge":266,"enrollmentInfo":267,"targetDuration":269,"studyType":19,"phases":4,"briefSummary":270,"conditions":271,"keywords":278,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":281,"startDateStruct":283,"completionDateStruct":285,"leadSponsor":287,"locationsCount":48},"100382854","dzhk-torch-plus-is-a-registry-for-patients-with-cardiomyopathies-and-serves-as-source-for-cardiovascular-research-studies-100382854","NCT04265040","DZHK TORCH-Plus is a Registry for Patients With Cardiomyopathies and Serves as Source for Cardiovascular Research Studies","TranslatiOnal Registry for CardiomyopatHies (TORCH) - Plus as Part of the German Centre for Cardiovascular Research (DZHK)","TORCH-Plus","Inclusion Criteria:\n\n* Non-ischemic structural cardiomyopathies\n* Age ≥ 18 or ≤ 80 years\n* The patient is able to understand the declaration of consent and to sign it dated\n* At least one of the following diagnoses depending on the specific TORCH-\n\nPlus inclusion \u002F exclusion - SOP:\n\nDilated Cardiomyopathy (DCM)\n\n* family \u002F genetic\n* inflammatory \u002F persistent myocarditis\n* idiopathic (after exclusion secondary cause)\n* left sided systolic dysfunction (EF ≤ 45%)\n\nLeft ventricular hypertrophy\n\n* sarcomere hypertrophic cardiomoypathia (HCM, HOCM)\n* amyloid (AL: light chains, TTR: transthyretin, wild type)\n\nLeft ventricular non-compaction cardiomyopathy (LVNC)\n\nArrhythmogenic right ventricular cardiomyopathy (ARVC \u002F D)\n\nExclusion Criteria:\n\nThe following exclusion criteria have been defined and must be taken from the TORCH-Plus specific inclusion \u002F exclusion - SOP in detail:\n\n* Age: \\\u003C18 years or\\> 80 years\n* Patient has other (cardiac) previous illnesses:\n\n  * uncontrollable arterial hypertension\n  * primary pulmonary arterial hypertension\n  * radiation therapy in the chest area\n  * addiction (drug or alcohol abuse)\n  * life expectancy \\\u003C1 year due to non-cardiological pre-existing conditions\n  * significant heart valve disease\n  * ischemic diseases and severe congenital heart diseases (including VSD, Fallot tetralogy, Ebstein anomaly)\n  * chemotoxic cardiomyopathy\n  * condition after myocarditis\n  * combination of several traditional risk factors (e.g. hypertension and diabetes mellitus)\n  * advanced chronic non-cardiac disease (e.g. chronic hepatitis or HIV)\n  * Tachymyopathy","80 Years",{"count":268,"type":18},2040,"4 Years","The DZHK TranslatiOnal Registry for CardiomyopatHies (DZHK TORCH) represents a unique resource of clinical data and high quality biological samples to enable innovative clinical and molecular studies on cardiomyopathies (CMP). As a multi-center German cardiomyopathy registry, TORCH has been prospectively admitting patients since December 2014. 2,300 patients were recruited as planned. Taken together, patient data showed that the prevalence of these diseases is much higher in men than in women, atrial fibrillation is common in all forms of CMPs as well as rare forms of disease indicate a higher risk and higher morbidity.\n\nThis DZHK TORCH register is now to be expanded with a second phase (DZHK TORCH-Plus). The second phase DZHK TORCH-Plus consists of 4 main modules: 1. \"Clinical phenotyping, follow-up \\& biosampling\" 2. \"Genomics\", 3. \"Inflammation\" and 4. \"Biomarker\". The central aims are 1) to significantly increase the number of probands (n = 4340) in order to better address the different types of CMPs, especially patients with rare CMP forms such as LVNC and ARVC or with probably molecularly explainable cardiomyopathies (familial DCM), 2) to prolong the longitudinal with a further follow-up to achieve sufficient events and thereby derive clinical recommendations for risk assessment, 3) to increase the number of probands with state-of-the-art phenotyping, 4) to pinpoint the effect of myocardial inflammation, fibrosis, gender and to determine or predict genotypes based for outcome, 5) to validate novel biomarkers developed in other DZHK studies, and 6) to foster active cooperation with international CMP registries and partners from industry.",[272,273,274,275,26,276,277,105],"Non-ischemic Cardiomyopathy","DCM - Dilated Cardiomyopathy","HCM - Hypertrophic Cardiomyopathy","HOCM - Hypertrophic Obstructive Cardiomyopathy","Left Ventricular Noncompaction Cardiomyopathy","Amyloidosis",[279],"Cardiomyopathies, registry, data, biomaterial, genetics","2023-11-29",{"date":282,"type":40},"2023-11-30",{"date":284,"type":40},"2020-08-18",{"date":286,"type":18},"2027-12",{"name":288,"class":47},"University Hospital Heidelberg"]