[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"arrhythmogenic-cardiomyopathy-ac-arvdc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:arrhythmogenic-cardiomyopathy-ac-arvdc":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,40,81],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"100647337","cardiac-rehabilitation-in-patients-with-high-genetic-risk-arrhythmogenic-cardiomyopathy-the-hgen-care-ac-trial-100647337",false,"NCT07708311","Cardiac Rehabilitation in Patients With High-Genetic-Risk Arrhythmogenic Cardiomyopathy: The HGEN-CARE-AC Trial","Exploratory Randomized Clinical Trial on the Safety and Feasibility of a Cardiac Rehabilitation Programme in Patients With High-Genetic-Risk Arrhythmogenic Cardiomyopathy (HGEN-CARE-AC Study)","HGEN-CARE-AC","Inclusion Criteria:\n\n* Participant must be 18 years of age or older at the time of signing the informed consent.\n* Definite diagnosis of arrhythmogenic cardiomyopathy (ACM) according to the 2024 European Task Force criteria.\n* Documented left or right ventricular involvement confirmed via transthoracic echocardiography or cardiac magnetic resonance imaging (MRI), characterized by abnormalities in regional contractility, presence of aneurysms, reduced ejection fraction, and\u002For late gadolinium enhancement (LGE).\n* Confirmed presence of a pathogenic or likely pathogenic genetic variant in the LMNA, DSP, FLNC, TMEM43, PLN, or DES genes.\n* Clinical stability maintained for 3 months or longer prior to inclusion, defined as the absence of hospital admissions, sustained ventricular arrhythmic events, or implantable cardioverter-defibrillator (ICD) shocks.\n* Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the consent form.\n\nExclusion Criteria:\n\n* Inability or physical contraindication to perform physical exercise at the time of inclusion.\n* Presence of overlapping phenotypes associated with other non-arrhythmogenic cardiomyopathies.\n* Active pregnancy.\n* Current engagement in competitive or high-intensity sports or exercise programs at the time of inclusion.","ALL","18 Years",{"count":20,"type":21},70,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to evaluate a structured and personalized cardiac rehabilitation program for patients diagnosed with arrhythmogenic cardiomyopathy (ACM) who carry high-risk genetic mutations. Historically, physical exercise has been strictly restricted in these patients due to the potential risk of triggering life-threatening arrhythmias and accelerating structural heart disease. However, complete inactivity leads to severe physical deconditioning and reduced quality of life. This study aims to address this clinical dilemma by investigating a safe way to prescribe exercise.\n\nThe primary research question is: Is a supervised, moderate-intensity exercise program safe, and does it avoid increasing the risk of cardiac arrhythmias or worsening right ventricular function compared to standard physical restriction?\n\nSecondary objectives include the evaluation of the impact of this tailored physical intervention on the participants' functional capacity, specifically measuring changes in physical fitness and peak oxygen consumption through cardiovascular testing. Additionally, the trial assesses the psychological benefits of the program, analyzing its effects on health-related quality of life, anxiety, and depression levels. The experimental group undergoing cardiac rehabilitation will be compared to a control group receiving conventional physical restriction guidelines to determine if the program is both safe and comprehensive.",[27],"Arrhythmogenic Cardiomyopathy (AC, ARVD\u002FC)","NOT_YET_RECRUITING","2026-07-17",{"date":31,"type":32},"2026-07-20","ACTUAL",{"date":34,"type":21},"2026-09",{"date":36,"type":21},"2028-09",{"name":38,"class":39},"Juan Jiménez Jáimez","OTHER",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":50,"phases":4,"briefSummary":51,"conditions":52,"keywords":60,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":4},"100646789","treatment-registry-of-arrhythmias-complications-and-electrocardiograms-in-arrhythmogenic-cardiomyopathies-100646789","NCT07688200","Treatment Registry of Arrhythmias, Complications and Electrocardiograms in Arrhythmogenic CardioMyopathies","Treatment Registry of Arrhythmias, Complications and Electrocardiograms in Arrhythmogenic CardioMyopathies: A Multicenter Retrospective Observational Study","TRACE-ACM","Inclusion Criteria:\n\n* Diagnosis of arrhythmogenic cardiomyopathy, including right-dominant arrhythmogenic right ventricular cardiomyopathy, biventricular arrhythmogenic cardiomyopathy, or left-dominant arrhythmogenic left ventricular cardiomyopathy.\n* ICD implantation.\n* Documented sustained ventricular tachyarrhythmia, including polymorphic ventricular tachycardia, ventricular fibrillation, or monomorphic ventricular tachycardia.\n* Periodic clinical and ICD follow-up.\n* Arrhythmia onset available from ICD electrograms and\u002For ECG recordings.\n* ECG\u002FEGM tracings available for analysis by the steering ECG committee.\n\nExclusion Criteria:\n\n* Incomplete ICD data or incomplete ICD follow-up.\n* Significant coronary artery disease, defined as coronary plaque greater than 50% at coronary angiography or coronary computed tomography angiography.\n* Primary valvular heart disease or congenital heart disease.\n* Infiltrative or inflammatory cardiomyopathies, including sarcoidosis or amyloidosis.\n* Previous exposure to therapies associated with cardiac toxicity, including chemotherapy.",{"count":49,"type":21},300,"OBSERVATIONAL","TRACE-ACM is a multicenter, retrospective, observational study of patients with arrhythmogenic cardiomyopathy who received an implantable cardioverter-defibrillator (ICD) and had documented ventricular tachyarrhythmias. The study aims to describe the prevalence and type of ICD-related complications, characterize ventricular arrhythmias documented by ICD electrograms and\u002For ECG recordings, and explore associations between clinical, device-related, and treatment-related factors and arrhythmic outcomes.",[27,53,54,55,56,57,58,59],"Ventricular Tachycardia (VT)","Ventricular Fibrillation","ICD","ICD Malfunction","ICD SHOCKS","Ventricular Arrhythmias and Cardiac Arrest","Ventricular Arrhythmia",[61,62,63,64,65,66,67,68,69,70,71],"Implantable cardioverter-defibrillator","ICD complications","Arrhythmogenic cardiomyopathy","Monomorphic ventricular tachycardia","Polymorphic ventricular tachycardia","Ventricular fibrillation","ICD electrograms","Arrhythmic storm","Pause-dependent arrhythmia initiation","Catheter ablation","Antiarrhythmic drugs","2026-06-30",{"date":74,"type":32},"2026-07-07",{"date":76,"type":21},"2026-07-01",{"date":78,"type":21},"2027-12-31",{"name":80,"class":39},"Policlinico Casilino ASL RMB",{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":88,"targetDuration":90,"studyType":50,"phases":4,"briefSummary":91,"conditions":92,"keywords":107,"overallStatus":143,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":153},"100562769","multimodal-and-multidisciplinary-approach-to-optimize-diagnostic-prognostic-and-therapeutic-management-of-patients-with-non-ischemic-cardiomyopathies-and-arrhythmogenic-inflammatory-phenotypes-a-multicenter-observational-retrospective-and-prospective-registry-study-100562769","NCT06607471","Multimodal and Multidisciplinary Approach to Optimize Diagnostic, Prognostic, and Therapeutic Management of Patients with Non-ischemic Cardiomyopathies and Arrhythmogenic-inflammatory Phenotypes: a Multicenter, Observational, Retrospective and Prospective Registry Study.","AINICM","Inclusion Criteria:\n\n* Written informed consent. For pediatric patients, consent will be obtained by parents, according to the laws applicable in each of the participating countries.\n* Clinical suspicion of NICM, and\u002For proven diagnosis of any NICM and\u002For genotype consistent with any NICM.\n\nNICMs will include but not limit to: DCM, HCM, RCM, ACM, inflammatory, infiltrative, dysmetabolic, mitochondrial, toxic, neuromuscular, rheumatologic\u002Fautoimmune cardiomyopathies, channelopathies with structural substrates, LVNC, PPCM, AMVP, AFD, athlete's heart, undefined and overlap cardiomyopathies. Additional diseases of the NICM spectrum will be included in parallel with the advance of the current knowledge.\n\nExclusion Criteria:\n\n* Absent informed consent.\n* Proven diagnosis of cardiac disease alternative to NICM.\n* Lack of diagnostic workup suitable for diagnosing NICM, detecting arrhythmias, or detecting M-Infl.\n* For patients retrospectively enrolled: lack of active status of follow-up at the enrolling center.",{"count":89,"type":21},15000,"30 Years","Non-ischemic cardiomyopathies (NICM) represent a heterogeneous group of pathologies characterized by absence of obstructive disease of the epicardial coronary vessels and distinct structural and functional changes of the myocardium. The main identified forms include dilated cardiomyopathy (DCM), hypertrophic cardiomyopathy (HCM), restrictive cardiomyopathy (RCM), and arrhythmogenic cardiomyopathy proper (ACM). More recently, further forms of cardiomyopathy have been described, less common and not uniquely classifiable, including: uncompressed myocardium (LVNC), peripartum cardiomyopathy (PPCM), structural correlates of arrhythmogenic mitral valve prolapse (AMVP), Anderson-Fabry disease (AFD), NICM associated with multi- system neuromuscular or autoimmune diseases, lysosomal diseases, glycogenosis, mitochondrial cytopathies and canal diseases with structural substrates. Finally, there are \"overlap\" forms, characterized by the sharing in the same subject of characteristic aspects of two or more of the above- mentioned diseases; and of the \"undefined\" forms, which to date do not reach the diagnostic criteria for any of the above-mentioned diseases.\n\nTo the best of current knowledge, there are two points discovered in scientific research, namely the description of the arrhythmogenic and \"inflammatory\" phenotypes in a broad sense, which are summarized here with the acronym AINICM. In detail:\n\n1. Arrhythmic manifestations account for the arrhythmogenic component of AINICM, which is not limited to ACM proper. In fact, most of the above diseases have a non-arrhythmic clinical presentation and a prevailing tendency to evolve towards a picture of cardiovascular decompensation. Although sudden arrhythmic death has been described throughout the spectrum of AINICM, early arrhythmic manifestations of such diseases have an unknown prevalence, an uncertain association with different disease genotypes and phenotypes, and still uncertain predictivity of long-term arrhythmic risk. At the same time, optimal diagnostic and therapeutic pathways in arrhythmias associated with AINICM are still being studied.\n2. Myocardial inflammation (M-Infl) accounts for the inflammatory component of AINICM, and has recently been described in association with many AINICM on a genetic basis, including undefined and arrhythmic forms. The data is of high interest not only in the diagnostic, but also in prognostic and therapeutic field. In fact, on the one hand the presence of M-Infl seems to have a physio- pathological role in AINICM; on the other, as already known in myocarditis, the optimal therapeutic paths of arrhythmias may differ in patients with and without M-Infl; in particular, also in the light of the preliminary data available in adult and paediatric AINICM, the inflammatory forms are expected to respond better to immunosuppressive therapy, the arrhythmogenic ones to an ablative therapy with frequent need of implantation of cardiac devices.\n\nBased on the clinical presentation, NICM patients will be divided into arrhythmic (AINICM) and non-arrhythmic patients as study and control groups , respectively. The AINICM group will include presentation with ventricular fibrillation (VF), either sustained or non-sustained ventricular tachycardia (VT; NSVT), frequent premature ventricular complexes (PVC), supraventricular arrhythmias (SVA) and bradyarrhythmias (BA). Clinical presentations other than arrhythmic, including chest pain and heart failure, will define the control group. In parallel, as shown in Figure 1, patients with any evidence of M-Infl will be compared with those showing no signs of M-Infl.",[93,94,95,96,27,97,98,99,100,101,102,103,104,105,106],"Non-ischemic Cardiomyopathy","Dilated Cardiomyopathy (DCM)","Hypertrophic Cardiomyopathy (HCM)","Restrictive Cardiomyopathy","Left Ventricular Noncompaction","Arrhythmogenic Mitral Valve Prolapse","Peripartum Cardiomyopathy","Anderson-Fabry Disease","Arrhythmic and Inflammatory Non-ischemic Cardiomyopathy","Inflammatory (Non-Arrhythmic) Non-ischemic Cardiomyopathy","Nonischemic Cardiomyopathy Sensu Strictu (Non-inflammatory, Non-arrhythmic)","Major Ventricular Arrhythmias, I.e. Sustained Ventricular Tachycardia, Ventricular Fibrillation, or Appropriate Therapy of Cardiac Device (defibrillators)","Overlapping Phenotype","Undefined Phenotypes",[63,108,109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129,130,131,132,133,134,135,136,137,138,139,140,66,141,142],"Adverse event","Anderson-Fabry disease","Arrhythmic and Inflammatory Non-ischemic cardiomyopathy","Arrhythmogenic mitral valve prolapse","Anti tachycardia pacing","Bradiarrhythmias","Cardiac magnetic resonance","Cardiac resynchronization therapy with defibrillator","Computed tomography","Development Safety Update Report","Ethics Committee","Electroanatomical map","Electrocardiogram","Endomyocardial biopsy","Good Clinical Practice","Hypertrophic cardiomyopathy","Implantable cardioverter defibrillator","Informed Consent Form","International Conference on Harmonization","Immunomodulatory therapy","Late gadolinium enhancement","Left ventricular ejection fraction","Left ventricular noncompaction","Last Visit of Last Subject","Myocardial inflammation","Non-ischemic cardiomyopathies","Positron emission tomography","Pacemaker","Peripartum cardiomyopathy","Premature ventricular complexes","Serious Adverse Event","Supraventricular arrhythmias","Ventricular arrhythmias","Ventricular tachycardia (sustained)","sudden cardiac death","RECRUITING","2024-09-18",{"date":146,"type":32},"2024-09-23",{"date":148,"type":32},"2018-01-30",{"date":150,"type":21},"2035-12-31",{"name":152,"class":39},"Scientific Institute San Raffaele",1]