[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100530181":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":24,"locations":34,"responsibleParty":244,"collaborators":248,"id":270,"slug":271,"hasResults":272,"nctId":273,"briefTitle":274,"officialTitle":275,"acronym":276,"eligibilityCriteria":277,"healthyVolunteers":272,"sex":278,"minAge":279,"maxAge":18,"enrollmentInfo":280,"targetDuration":18,"studyType":283,"phases":284,"briefSummary":286,"conditions":287,"keywords":293,"overallStatus":58,"whyStopped":18,"lastUpdateSubmitDate":295,"lastUpdatePostDateStruct":296,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":303,"locationsCount":304},{"fullName":5,"class":6},"University Health Network, Toronto","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Stop Group","EXPERIMENTAL","This group will stop their heart failure medication(s) under the supervision of the study team. The investigators expect most participants in the STOP group to only be on beta-blockers (BB) and\u002For angiotensin-converting-enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARB). The ACEi or ARB will be stopped first. The ACEi or ARB will be reduced by 50% every 7 days and stopped 7 days after 25% of maximal recommended dose for HF is reached. At this point (or at baseline if only on BB), the BB dose will be reduced by 50% every 7 days then stopped once 25% of the maximal dose is reached. Participants on 75% of the maximal dose will be reduced to 50% of the maximal dose before reducing by 50% every 7 days. Other HF medications will be stopped as follows: MRA: reduce by 50% every 7 days then stop once 50% of maximal dose is reached; SGLT2i: stopped without titration, ARNi: reduce by 50% every 7 days then stop once 25% of the maximal dose.",[13],"Other: Stopping Heart Failure Medication(s)",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard of Care Group","NO_INTERVENTION","This group with continue with their heart failure medication(s) for at least 1 year.",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":18},"Stopping Heart Failure Medication(s)","This group will stop their heart failure medication(s) under the supervision of the study team.",[9],[25,30],{"name":26,"role":27,"phone":28,"phoneExt":18,"email":29},"Paaladinesh Thavendiranathan, MD","CONTACT","416-340-5326","dinesh.thavendiranathan@uhn.ca",{"name":31,"role":27,"phone":32,"phoneExt":18,"email":33},"Sadia Khan","437-522-6441","Sadia.Khan@uhn.ca",[35,56,72,88,107,121,135,148,161,170,186,203,217,232],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"University of California, Los Angeles","NOT_YET_RECRUITING","Los Angeles","California","90095","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-118.24368,34.05223,{"lat":47,"lon":46},[50,54],{"name":51,"role":27,"phone":52,"phoneExt":18,"email":53},"Eric Yang, MD","310-825-4321","EHYang@mednet.ucla.edu",{"name":51,"role":55,"phone":18,"phoneExt":18,"email":18},"PRINCIPAL_INVESTIGATOR",{"facility":57,"status":58,"city":59,"state":60,"zip":61,"country":41,"countryCode":42,"cosmosGeoPoint":62,"geoPoint":66,"contacts":67},"Brigham and Women's Hospital","RECRUITING","Boston","Massachusetts","02115",{"type":44,"coordinates":63},[64,65],-71.05977,42.35843,{"lat":65,"lon":64},[68,71],{"name":69,"role":27,"phone":18,"phoneExt":18,"email":70},"Tomas Neilan, MD","TNEILAN@mgh.harvard.edu",{"name":69,"role":55,"phone":18,"phoneExt":18,"email":18},{"facility":73,"status":58,"city":74,"state":75,"zip":76,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"Baker Heart and Diabetes Institute","Melbourne","Victoria","3004","Australia","AU",{"type":44,"coordinates":80},[81,82],144.96332,-37.814,{"lat":82,"lon":81},[85,87],{"name":86,"role":27,"phone":18,"phoneExt":18,"email":18},"Tom Marwick, MD",{"name":86,"role":55,"phone":18,"phoneExt":18,"email":18},{"facility":89,"status":37,"city":90,"state":91,"zip":92,"country":93,"countryCode":94,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"Cardio-Oncology Clinic, MAHI, University of Alberta Hospital","Edmonton","Alberta","T6G 1C9","Canada","CA",{"type":44,"coordinates":96},[97,98],-113.46871,53.55014,{"lat":98,"lon":97},[101,103,104],{"name":102,"role":27,"phone":18,"phoneExt":18,"email":18},"Gabor Gyenes, MD",{"name":102,"role":55,"phone":18,"phoneExt":18,"email":18},{"name":105,"role":106,"phone":18,"phoneExt":18,"email":18},"Edith Pituskin, PhD","SUB_INVESTIGATOR",{"facility":108,"status":58,"city":109,"state":110,"zip":111,"country":93,"countryCode":94,"cosmosGeoPoint":112,"geoPoint":116,"contacts":117},"St. Boniface Hospital","Winnipeg","Manitoba","R2H 2A6",{"type":44,"coordinates":113},[114,115],-97.14704,49.8844,{"lat":115,"lon":114},[118,120],{"name":119,"role":27,"phone":18,"phoneExt":18,"email":18},"Davinder Jassal, MD",{"name":119,"role":55,"phone":18,"phoneExt":18,"email":18},{"facility":122,"status":37,"city":123,"state":124,"zip":125,"country":93,"countryCode":94,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"Hamilton General Hospital","Hamilton","Ontario","L8L 2X2",{"type":44,"coordinates":127},[128,129],-79.84963,43.25011,{"lat":129,"lon":128},[132,134],{"name":133,"role":27,"phone":18,"phoneExt":18,"email":18},"Darryl Leong, MD",{"name":133,"role":55,"phone":18,"phoneExt":18,"email":18},{"facility":136,"status":58,"city":137,"state":124,"zip":138,"country":93,"countryCode":94,"cosmosGeoPoint":139,"geoPoint":143,"contacts":144},"University of Ottawa Heart Institute","Ottawa","K1Y 4W7",{"type":44,"coordinates":140},[141,142],-75.69812,45.41117,{"lat":142,"lon":141},[145,147],{"name":146,"role":27,"phone":18,"phoneExt":18,"email":18},"Ian Paterson, MD",{"name":146,"role":55,"phone":18,"phoneExt":18,"email":18},{"facility":149,"status":37,"city":150,"state":124,"zip":151,"country":93,"countryCode":94,"cosmosGeoPoint":152,"geoPoint":156,"contacts":157},"St Michael's Hospital","Toronto","M5B 1W8",{"type":44,"coordinates":153},[154,155],-79.39864,43.70643,{"lat":155,"lon":154},[158,160],{"name":159,"role":27,"phone":18,"phoneExt":18,"email":18},"Kim Connelly, MD",{"name":159,"role":55,"phone":18,"phoneExt":18,"email":18},{"facility":162,"status":58,"city":150,"state":124,"zip":163,"country":93,"countryCode":94,"cosmosGeoPoint":164,"geoPoint":166,"contacts":167},"University Health Network","M5G2C4",{"type":44,"coordinates":165},[154,155],{"lat":155,"lon":154},[168,169],{"name":26,"role":27,"phone":28,"phoneExt":18,"email":29},{"name":26,"role":55,"phone":18,"phoneExt":18,"email":18},{"facility":171,"status":37,"city":172,"state":18,"zip":18,"country":173,"countryCode":174,"cosmosGeoPoint":175,"geoPoint":179,"contacts":180},"Maria Sklodowska-Curie National Research Institute of Oncology","Warsaw","Poland","PL",{"type":44,"coordinates":176},[177,178],21.01178,52.22977,{"lat":178,"lon":177},[181,185],{"name":182,"role":27,"phone":183,"phoneExt":18,"email":184},"Anna Borowiec, MD","48 22 546 20 00","Anna.Borowiec@nio.gov.pl",{"name":182,"role":55,"phone":18,"phoneExt":18,"email":18},{"facility":187,"status":37,"city":188,"state":18,"zip":189,"country":190,"countryCode":191,"cosmosGeoPoint":192,"geoPoint":196,"contacts":197},"La Paz University Hospital","Madrid","28046","Spain","ES",{"type":44,"coordinates":193},[194,195],-3.70256,40.4165,{"lat":195,"lon":194},[198,202],{"name":199,"role":27,"phone":200,"phoneExt":18,"email":201},"Teresa Lopez Fernandez, MD","+34 917 27 70 00","teresa.lopez@salud.madrid.org",{"name":199,"role":55,"phone":18,"phoneExt":18,"email":18},{"facility":204,"status":58,"city":205,"state":205,"zip":18,"country":206,"countryCode":207,"cosmosGeoPoint":208,"geoPoint":212,"contacts":213},"Barts Health NHS Trust, University College London","London","United Kingdom","UK",{"type":44,"coordinates":209},[210,211],-0.12574,51.50853,{"lat":211,"lon":210},[214,216],{"name":215,"role":27,"phone":18,"phoneExt":18,"email":18},"Charlotte Manisty, MD",{"name":215,"role":55,"phone":18,"phoneExt":18,"email":18},{"facility":218,"status":37,"city":219,"state":18,"zip":220,"country":206,"countryCode":207,"cosmosGeoPoint":221,"geoPoint":225,"contacts":226},"Liverpool Heart and Chest Hospital","Liverpool","L14 3PE",{"type":44,"coordinates":222},[223,224],-2.97794,53.41058,{"lat":224,"lon":223},[227,231],{"name":228,"role":27,"phone":229,"phoneExt":18,"email":230},"Rebecca Dobson, MD","44 151 600 1616","Rebecca.Dobson@lhch.nhs.uk",{"name":228,"role":55,"phone":18,"phoneExt":18,"email":18},{"facility":233,"status":37,"city":205,"state":18,"zip":18,"country":206,"countryCode":207,"cosmosGeoPoint":234,"geoPoint":236,"contacts":237},"Guy's and St Thomas' NHS Foundation Trust (Royal Brompton Hospital)",{"type":44,"coordinates":235},[210,211],{"lat":211,"lon":210},[238,241,242],{"name":239,"role":27,"phone":240,"phoneExt":18,"email":18},"Alexander Lyon, MD","44 20 7352 8121",{"name":239,"role":55,"phone":18,"phoneExt":18,"email":18},{"name":243,"role":106,"phone":18,"phoneExt":18,"email":18},"Siva Tharshini Ramalingam, MD",{"type":245,"investigatorFullName":246,"investigatorTitle":247,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"SPONSOR_INVESTIGATOR","Dinesh Thavendiranathan","MD, SM, FRCPC, FASE, Cardiologist, Professor of Medicine Canada Research Chair in Cardio-Oncology, Clinical Director, Echocardiography Laboratory, Director, Ted Rogers Program in Cardiotoxicity Prevention",[249,251,253,254,256,258,259,260,261,263,265,267,269],{"name":250,"class":6},"Unity Health Toronto",{"name":252,"class":6},"Hamilton Health Sciences Corporation",{"name":108,"class":6},{"name":255,"class":6},"Ottawa Heart Institute Research Corporation",{"name":257,"class":6},"University College London Hospitals",{"name":57,"class":6},{"name":73,"class":6},{"name":36,"class":6},{"name":262,"class":6},"Alberta Health services",{"name":264,"class":6},"Hospital Universitario La Paz",{"name":266,"class":6},"Liverpool Heart and Chest Hospital NHS Foundation Trust",{"name":268,"class":6},"Guy's and St Thomas' NHS Foundation Trust",{"name":171,"class":6},"100530181","phase-4-the-stop-med-ctrcd-trial-100530181",false,"NCT06183437","The STOP-MED CTRCD Trial","A Multi-Centre Non-Inferiority Randomized Controlled Trial of STOPping Cardiac MEDications in Patients With Normalized Cancer Therapy Related Cardiac Dysfunction: The STOP-MED CTRCD Trial","STOP-MED CTRCD","Inclusion Criteria:\n\n* Adult patients (age ≥18 years) with cancer therapy completed more than 6 months prior (other than hormonal therapy) and no plan for further cancer treatments with potential risk for CTRCD.\n* Prior cancer therapy with anthracyclines and\u002F or HER2-targeted therapy.\n* Prior asymptomatic, moderate to severe CTRCD, defined using the ESC\u002FICOS criteria (MODERATE: ≥10% drop in LVEF from baseline to 40% to 49.9% OR \\\u003C10% drop to 40-49.9% with a reduction in GLS by \\>15% or new abnormal Troponin I\u002FT or NT-proBNP or SEVERE: new LVEF reduction to \\\u003C40% from normal baseline LVEF), diagnosed within 1 year of completing potentially cardiotoxic cancer therapy.\n* Current use of ≥1 HF medication started for CTRCD for at least 6 months with LVEF ≥55% by recently performed (≤6 months) echocardiogram, normal sex and age adjusted NT-proBNP or BNP ≤97.5th Centile, and no symptoms attributable to HF.\n* Reference ranges for NT-proBNP and BNP by age and sex:\n\n\\\u003C30 years: Female: NT-proBNP ≤196 pg\u002Fml, BNP ≤55 pg\u002Fml Male: NT-proBNP ≤104 pg\u002Fml, BNP ≤29 pg\u002Fml\n\n30-39 years: Female: NT-proBNP ≤209 pg\u002Fml, BNP ≤59 pg\u002Fml Male: NT-proBNP ≤102 pg\u002Fml, BNP ≤29 pg\u002Fml\n\n40-49 years: Female: NT-proBNP ≤233 pg\u002Fml, BNP ≤65 pg\u002Fml Male: NT-proBNP ≤137 pg\u002Fml, BNP ≤38 pg\u002Fml\n\n50-59 years: Female: NT-proBNP ≤299 pg\u002Fml, BNP ≤84 pg\u002Fml Male: NT-proBNP ≤195 pg\u002Fml, BNP ≤55 pg\u002Fml\n\n60-69 years: Female: NT-proBNP ≤399 pg\u002Fml, BNP ≤112 pg\u002Fml Male: NT-proBNP ≤333 pg\u002Fml, BNP ≤93 pg\u002Fml\n\n70-79 years: Female: NT-proBNP ≤743 pg\u002Fml, BNP ≤208 pg\u002Fml Male: NT-proBNP ≤763 pg\u002Fml, BNP ≤214 pg\u002Fml\n\n≥80 years: Female: NT-proBNP ≤2,704 pg\u002Fml, BNP ≤757 pg\u002Fml Male: NT-proBNP ≤6,792 pg\u002Fml, BNP ≤1,902 pg\u002Fml\n\n* Confirmation of LVEF ≥55% and normal volumes at baseline CMR (i.e., some patients recruited based on echocardiography, may be excluded if baseline CMR LVEF\u002Fvolumes are not normal). This is included given that the primary outcome includes the use of CMR LVEF.\n\nExclusion Criteria:\n\n* Indication for continuation of HF medications i.e., ongoing HF symptoms, chronic kidney disease (CKD), vascular disease, atrial or ventricular arrythmias, other (note: participants with hypertension will be switched to other guideline-based antihypertensive therapy).\n* Contraindications for CMR (e.g., MRI non-compatible implanted pacemakers).\n* Patients with cardiac devices i.e. defibrillator, CRT, pacemaker, etc.\n* Continued use of loop diuretic therapy for heart failure purposes i.e., furosemide.\n* Life expectancy \\\u003C1 year or metastatic disease.\n* Prior history of major cardiovascular event (defined as myocardial infarction, cerebral vascular event, admission for HF) or therapeutic cardiovascular procedure (e.g., percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG)).\n* Issues that prevent communication, understanding or presentation for study-related visits and inability to provide informed consent.","ALL","18 Years",{"count":281,"type":282},335,"ESTIMATED","INTERVENTIONAL",[285],"PHASE4","Cancer therapy-related cardiac dysfunction (CTRCD) is when the heart's ability to pump oxygenated blood to the body is compromised. It is a side effect of cancer therapy which can occur as commonly as in 1 in 5 patients. When this occurs, heart failure medications are started to protect the heart from progressing to heart failure. With early detection and treatment, heart function recovers to normal in \\>80% of patients. Unfortunately, heart failure medications are associated with an undesirable long-term pill burden, financial costs, and side-effects (e.g., dizziness and fatigue). As a result, cancer survivors frequently ask if they can safely stop their heart failure medications once their heart function has returned to normal. Currently there is no scientific evidence in this area of Cardio-Oncology.\n\nTo address this knowledge gap, the investigators have designed a randomized control trial to assess the safety of stopping heart failure medication in patients with CTRCD and recovered heart function. The investigators will enrol patients who have completed their cancer therapy and are on heart medications for their CTRCD, which has now normalized. The investigators will randomize patients with no other reasons to continue heart failure medications (e.g., kidney disease) to continuing or stopping their heart medications safely. All patients will undergo a cardiac MRI at baseline, 1 and 5 years with safety assessments at 6-8 weeks, 6 months and 3 and 5 years. The investigators will determine if stopping medications is non-inferior to continuing medications by counting the numbers of patients who develop heart dysfunction by 1 year in each group.",[288,289,290,291,292],"Heart Failure","Cardiotoxicity","Cardiac Toxicity","Antineoplastics Toxicity","Cancer",[294],"cancer therapy related cardiac dysfunction","2026-03-25",{"date":297,"type":298},"2026-03-30","ACTUAL",{"date":300,"type":298},"2024-03-04",{"date":302,"type":282},"2031-12",{"name":246,"class":6},14]