[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100590211":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":41,"responsibleParty":284,"collaborators":288,"id":291,"slug":292,"hasResults":293,"nctId":294,"briefTitle":295,"officialTitle":295,"acronym":296,"eligibilityCriteria":297,"healthyVolunteers":293,"sex":298,"minAge":299,"maxAge":26,"enrollmentInfo":300,"targetDuration":26,"studyType":303,"phases":304,"briefSummary":306,"conditions":307,"keywords":314,"overallStatus":44,"whyStopped":26,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":324,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":332},{"fullName":5,"class":6},"University of Rochester","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Metoprolol Succinate Group","ACTIVE_COMPARATOR","Participants in this group will remain on their current treatment with metoprolol succinate. The dose of metoprolol succinate may be titrated to achieve recommended target doses as per the study protocol. The aim is to assess the outcomes associated with continued use of metoprolol succinate in patients with heart failure and an implantable cardioverter defibrillator (ICD).",[13],"Drug: Metoprolol Succinate",{"label":15,"type":16,"description":17,"interventionNames":18},"Carvedilol Group","EXPERIMENTAL","Participants in this group will switch from metoprolol succinate to carvedilol at an equivalent dose. The dose of carvedilol will be titrated to the recommended target dose as per the study protocol. The goal is to evaluate the comparative effectiveness of carvedilol compared to metoprolol succinate in reducing cardiovascular events in patients with heart failure and an ICD.",[19],"Drug: Carvedilol",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Metoprolol Succinate","Metoprolol succinate is a beta-blocker used for the management of heart failure with reduced ejection fraction (HFrEF). In this study, participants in the metoprolol succinate group will remain on their current treatment regimen with metoprolol succinate. The dose will be titrated to the recommended target dose as per the study protocol. The intervention aims to evaluate the effectiveness of continued use of metoprolol succinate in patients with heart failure and an implantable cardioverter defibrillator (ICD).",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Carvedilol","Carvedilol is a non-selective beta-blocker with alpha-blocking activity used in the treatment of heart failure. In this study, participants assigned to the carvedilol group will switch from metoprolol succinate to carvedilol at an equivalent dose. The carvedilol dose will be titrated to recommended target doses according to the study protocol. This intervention aims to compare the effectiveness of carvedilol versus metoprolol succinate in improving clinical outcomes in patients with heart failure and ICDs.",[15],[32,37],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Mehmet Aktas, M.D.","CONTACT","585-275-5391","Mehmet_Aktas@URMC.Rochester.edu",{"name":38,"role":34,"phone":39,"phoneExt":26,"email":40},"Nicole Guerrero, MBA","0000000000","nicole.guerrero@heart.rochester.edu",[42,65,83,101,120,139,158,176,190,208,227,246,265],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"HonorHealth","RECRUITING","Scottsdale","Arizona","85258","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-111.89903,33.50921,{"lat":54,"lon":53},[57,61],{"name":58,"role":34,"phone":59,"phoneExt":26,"email":60},"Geoffrey Jao, MD","480-882-7750","gjao@honorhealth.com",{"name":62,"role":34,"phone":63,"phoneExt":26,"email":64},"Mary Futch Moyer","480-323-1043","mfutch@honorhealth.com",{"facility":66,"status":44,"city":67,"state":68,"zip":69,"country":48,"countryCode":49,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"AdventHealth Redmond","Rome","Georgia","30165",{"type":51,"coordinates":71},[72,73],-85.16467,34.25704,{"lat":73,"lon":72},[76,80],{"name":77,"role":34,"phone":78,"phoneExt":26,"email":79},"Charles Jackson, MD","706-802-3139","charles.jackson.md@adventhealth.com",{"name":81,"role":34,"phone":78,"phoneExt":26,"email":82},"Kathy Jones","kathy.d.jones@adventhealth.com",{"facility":84,"status":44,"city":85,"state":86,"zip":87,"country":48,"countryCode":49,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"AdventHealth Shawnee Mission","Shawnee Mission","Kansas","66204",{"type":51,"coordinates":89},[90,91],-94.66583,39.02,{"lat":91,"lon":90},[94,98],{"name":95,"role":34,"phone":96,"phoneExt":26,"email":97},"Obadah Al Chekakie, MD","913-676-2558","MObadah.AlChekakie.MD@AdventHealth.com",{"name":99,"role":34,"phone":96,"phoneExt":26,"email":100},"Megan Kelly","Megan.Kelly1@adventhealth.com",{"facility":102,"status":44,"city":103,"state":104,"zip":105,"country":48,"countryCode":49,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"Henry Ford Health System","Detroit","Michigan","48202",{"type":51,"coordinates":107},[108,109],-83.04575,42.33143,{"lat":109,"lon":108},[112,116],{"name":113,"role":34,"phone":114,"phoneExt":26,"email":115},"Waddah Maskoun, MD","313-916-2417","wmaskou1@hfhs.org",{"name":117,"role":34,"phone":118,"phoneExt":26,"email":119},"Briita Wanhala","313-916-9575","bwanhal1@hfhs.org",{"facility":121,"status":44,"city":122,"state":123,"zip":124,"country":48,"countryCode":49,"cosmosGeoPoint":125,"geoPoint":129,"contacts":130},"University of Mossouri","Columbia","Missouri","65212",{"type":51,"coordinates":126},[127,128],-92.33407,38.95171,{"lat":128,"lon":127},[131,135],{"name":132,"role":34,"phone":133,"phoneExt":26,"email":134},"Brian Bostick, MD","573-884-1606","bostickb@health.missouri.edu",{"name":136,"role":34,"phone":137,"phoneExt":26,"email":138},"Charles Donigian","573-884-9430","donigianc@health.missouri.edu",{"facility":140,"status":44,"city":141,"state":142,"zip":143,"country":48,"countryCode":49,"cosmosGeoPoint":144,"geoPoint":148,"contacts":149},"Creighton University Medical Center","Omaha","Nebraska","68124",{"type":51,"coordinates":145},[146,147],-95.94043,41.25626,{"lat":147,"lon":146},[150,154],{"name":151,"role":34,"phone":152,"phoneExt":26,"email":153},"Attila Roka, MD","402-398-5880","attilaroka@creighton.edu",{"name":155,"role":34,"phone":156,"phoneExt":26,"email":157},"Lois A. Rasmussen","402-343-8539","lois.rasmussen@commonspirit.org",{"facility":159,"status":44,"city":160,"state":161,"zip":162,"country":48,"countryCode":49,"cosmosGeoPoint":163,"geoPoint":167,"contacts":168},"Suny Downstate","Brooklyn","New York","11203",{"type":51,"coordinates":164},[165,166],-73.94958,40.6501,{"lat":166,"lon":165},[169,173],{"name":170,"role":34,"phone":171,"phoneExt":26,"email":172},"Adam S Budzikowski, MD","718-270-4147","abudzikowski@downstate.edu",{"name":174,"role":34,"phone":171,"phoneExt":26,"email":175},"Ann Harris","ann.harris@downstate.edu",{"facility":177,"status":44,"city":160,"state":161,"zip":178,"country":48,"countryCode":49,"cosmosGeoPoint":179,"geoPoint":181,"contacts":182},"New York-Presbyterian Brooklyn Methodist Hospital","11215",{"type":51,"coordinates":180},[165,166],{"lat":166,"lon":165},[183,187],{"name":184,"role":34,"phone":185,"phoneExt":26,"email":186},"Gioia Turitto, MD","718-780-3626","git9006@nyp.org",{"name":188,"role":34,"phone":26,"phoneExt":26,"email":189},"Shana Hayes, M.S.","cmc9055@nyp.org",{"facility":191,"status":44,"city":192,"state":161,"zip":193,"country":48,"countryCode":49,"cosmosGeoPoint":194,"geoPoint":198,"contacts":199},"University of Rochester Medical Center","Rochester","14642",{"type":51,"coordinates":195},[196,197],-77.61556,43.15478,{"lat":197,"lon":196},[200,204],{"name":201,"role":34,"phone":202,"phoneExt":26,"email":203},"Amole Ojo, MD","585-275-4775","amole_ojo@urmc.rochester.edu",{"name":205,"role":34,"phone":206,"phoneExt":26,"email":207},"Samantha Delmartino","585-273-3877","samantha_delmartino@urmc.rochester.edu",{"facility":209,"status":44,"city":210,"state":211,"zip":212,"country":48,"countryCode":49,"cosmosGeoPoint":213,"geoPoint":217,"contacts":218},"CHRISTUS Trinity Mother Frances Health System","Tyler","Texas","75701",{"type":51,"coordinates":214},[215,216],-95.30106,32.35126,{"lat":216,"lon":215},[219,223],{"name":220,"role":34,"phone":221,"phoneExt":26,"email":222},"Joshua Rutland, MD","903-606-7525","joshua.rutland@christushealth.org",{"name":224,"role":34,"phone":225,"phoneExt":26,"email":226},"Carol Cushman","903-606-8846","carol.cushman@christushealth.org",{"facility":228,"status":44,"city":229,"state":230,"zip":231,"country":48,"countryCode":49,"cosmosGeoPoint":232,"geoPoint":236,"contacts":237},"Health University of Utah","Salt Lake City","Utah","84112",{"type":51,"coordinates":233},[234,235],-111.89105,40.76078,{"lat":235,"lon":234},[238,242],{"name":239,"role":34,"phone":240,"phoneExt":26,"email":241},"Ravi Ranjan, MD","801-587-5888","ravi.ranjan@hsc.utah.edu",{"name":243,"role":34,"phone":244,"phoneExt":26,"email":245},"Audra Eaquinto","801-646-8073","audra.eaquinto@hsc.utah.edu",{"facility":247,"status":44,"city":248,"state":249,"zip":250,"country":48,"countryCode":49,"cosmosGeoPoint":251,"geoPoint":255,"contacts":256},"Virginia Commonwealth University","Richmond","Virginia","23298",{"type":51,"coordinates":252},[253,254],-77.46026,37.55376,{"lat":254,"lon":253},[257,261],{"name":258,"role":34,"phone":259,"phoneExt":26,"email":260},"Keyur Shah, MD","804-828-4571","keyur.shah@vcuhealth.org",{"name":262,"role":34,"phone":263,"phoneExt":26,"email":264},"Anna Baranova","804-628-7455","anna.baranova2@vcuhealth.org",{"facility":266,"status":44,"city":267,"state":268,"zip":269,"country":48,"countryCode":49,"cosmosGeoPoint":270,"geoPoint":274,"contacts":275},"University of Wisconsin Hospital and Clinics","Madison","Wisconsin","53792",{"type":51,"coordinates":271},[272,273],-89.40123,43.07305,{"lat":273,"lon":272},[276,280],{"name":277,"role":34,"phone":278,"phoneExt":26,"email":279},"Ryan Kipp, MD","608-265-4188","rtkipp@medicine.wisc.edu",{"name":281,"role":34,"phone":282,"phoneExt":26,"email":283},"Karen Olson","608-263-1544","kjolson@medicine.wisc.edu",{"type":285,"investigatorFullName":286,"investigatorTitle":287,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Mehmet Aktas","Associate Professor - Department of Medicine, Cardiology (SMD)",[289],{"name":290,"class":6},"Patient-Centered Outcomes Research Institute","100590211","phase-4-comparative-effectiveness-of-carvedilol-versus-metoprolol-succinate-in-heart-failure-patients-with-an-implantable-cardioverter-defibrillator-100590211",false,"NCT06964464","Comparative Effectiveness of Carvedilol Versus Metoprolol Succinate in Heart Failure Patients With an Implantable Cardioverter Defibrillator","CARVTOP-ICD","Inclusion Criteria:\n\n* Age ≥ 18 years\n* ICD implanted for primary prevention for HFrEF (either ICM or NICM) with remote monitoring capability\n* Current treatment with metoprolol succinate and willing to switch to carvedilol\n* LVEF \\\u003C50% during the past 12 months prior to consent\n\nExclusion Criteria:\n\n* Unwilling or unable to follow the protocol\n* Treatment with any other ßB than metoprolol succinate or no ßB treatment\n* Known prior intolerance or contraindication to carvedilol\n* Systolic blood pressure \\\u003C100 mmHg\n* Enrollment in another clinical trial\n* Inability or unwilling to consent","ALL","18 Years",{"count":301,"type":302},2000,"ESTIMATED","INTERVENTIONAL",[305],"PHASE4","This prospective, multicenter, open-label, randomized comparative effectiveness trial, titled CARVTOP-ICD, evaluates the impact of carvedilol versus metoprolol succinate in patients with heart failure with reduced ejection fraction (HFrEF) and an implantable cardioverter defibrillator (ICD). The study will enroll 2,000 participants across 100 U.S. sites and includes an 18-month feasibility phase with 100 participants from 15 sites. Eligible participants must be currently treated with metoprolol succinate and willing to switch to carvedilol, with randomization in a 1:1 ratio. Participants will be followed for up to 3 years, with regular assessments including ICD interrogations, medication adherence, healthcare utilization, and quality of life surveys. The primary endpoint is the first occurrence of any ICD therapy (appropriate or inappropriate), cardiovascular (CV) hospitalization, or CV death. Secondary endpoints include ICD shock burden, healthcare utilization, and patient-reported quality of life. The trial aims to provide high-quality comparative data to address clinical equipoise surrounding the two commonly used beta-blockers in HFrEF management.",[308,309,310,311,312,313],"Heart Failure With Reduced Ejection Fraction (HFrEF)","Sudden Cardiac Death","Ventricular Arrhythmia","Implantable Cardioverter Defibrillator (ICD)","Beta-blocker Therapy","Cardiomyopathy",[315,316,317,318,319,320,321,322],"arrhythmia","heart failure","ICD","implantable cardioverter defibrillator","ICD shock","carvedilol","metoprolol succinate","beta-blocker","2025-09-12",{"date":325,"type":326},"2025-09-18","ACTUAL",{"date":328,"type":326},"2025-08-17",{"date":330,"type":302},"2031-07-01",{"name":5,"class":6},13]