[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647337":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":18,"locations":18,"responsibleParty":25,"collaborators":29,"id":31,"slug":32,"hasResults":33,"nctId":34,"briefTitle":35,"officialTitle":36,"acronym":37,"eligibilityCriteria":38,"healthyVolunteers":33,"sex":39,"minAge":40,"maxAge":18,"enrollmentInfo":41,"targetDuration":18,"studyType":44,"phases":45,"briefSummary":47,"conditions":48,"keywords":18,"overallStatus":50,"whyStopped":18,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":18},{"fullName":5,"class":6},"Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cardiac Rehabilitation Program","EXPERIMENTAL","Participants randomized to this experimental arm will engage in a structured, personalized, and supervised physical exercise program at the hospital's specialized Cardiac Rehabilitation Unit for a duration of 12 weeks. The intervention consists of customized, moderate-intensity training sessions designed and supervised by qualified clinical personnel. Training intensity is strictly individualized, bounded by safe target heart rate thresholds and workloads derived from each participant's baseline maximal cardiopulmonary exercise testing (CPET).",[13],"Behavioral: Cardiac Rehabilitation Programme",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Physical Restriction","NO_INTERVENTION","Participants randomized to this active comparator control arm will maintain conventional clinical care as prescribed by current guidelines for high-genetic-risk arrhythmogenic cardiomyopathy. This involves strict adherence to physical restriction guidelines, including complete abstinence from competitive, high-intensity sports and strenuous physical exercise. Participants are encouraged to maintain basic activities of daily living and light leisure-time physical habits, serving as a direct control baseline to evaluate safety outcomes.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"BEHAVIORAL","Cardiac Rehabilitation Programme","A structured, personalized, and supervised cardiac rehabilitation program based on moderate-intensity physical exercise, tailored specifically for high-risk genotype-positive arrhythmogenic cardiomyopathy (ACM) patients.\n\nThe intervention follows the FITT (Frequency, Intensity, Time, Type) principles:\n\nFrequency: 2 to 3 supervised sessions per week for a total duration of 12 consecutive weeks.\n\nIntensity: Strictly restricted to a moderate-intensity zone. The target training heart rate is set individually, bounded between the first ventilatory threshold (VT1) and a safe ceiling well below the second ventilatory threshold (VT2) or any individual arrhythmic thresholds identified during baseline cardiopulmonary exercise testing (CPET).\n\nTime: Each session lasts between 90 minutes, including a 10-minute progressive warm-up and a 10-minute cool-down phase.\n\nType: Continuous aerobic exercise primarily performed on a cycle ergometer o",[9],{"type":26,"investigatorFullName":27,"investigatorTitle":28,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"SPONSOR_INVESTIGATOR","Juan Jiménez Jáimez","MD, PhD, Head of the Arrhythmia and Familial Cardiopathies Unit in Virgen de las Nieves Hospital in Granada, Spain",[30],{"name":5,"class":6},"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":42,"type":43},70,"ESTIMATED","INTERVENTIONAL",[46],"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.",[49],"Arrhythmogenic Cardiomyopathy (AC, ARVD\u002FC)","NOT_YET_RECRUITING","2026-07-17",{"date":53,"type":54},"2026-07-20","ACTUAL",{"date":56,"type":43},"2026-09",{"date":58,"type":43},"2028-09",{"name":27,"class":6}]