[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07058064":3,"trial-entities:NCT07058064":144,"trial-summary:NCT07058064":147},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":84,"secondary_outcomes":95,"sex":96,"minimum_age":97,"maximum_age":16,"healthy_volunteers":14,"eligibility_criteria":98,"std_ages":107,"locations":110,"central_contacts":133,"overall_officials":137,"references":139,"see_also_links":140},"NCT07058064","25-002911","WATCH (Wearable Artificial inTelligence for Cardiac Function and Health Monitoring)","RECRUITING","2029-06-29","2025-10","2025-10-15","2025-07-18","Mayo Clinic","OTHER",false,"The purpose of this study is to find a cost effective cardiovascular (CV) surveillance of cancer survivors over long periods of time to prevent the risk of progression of heart failure (HF) and related morbidity and mortality. Mobile device-based artificial intelligence (AI)-electrocardiogram (ECG) can reliably detect cardiac dysfunction in lymphoma and sarcoma survivors and smart watch based surveillance for cardiotoxicity is feasible and reliable.",null,[18,19],"Lymphoma","Sarcoma",[],"INTERVENTIONAL","SCREENING",[24],"NA",{"count":26,"type":27},250,"ESTIMATED",[29,39,47,54,58,64,68,74,80],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":36},"PROCEDURE","Electrocardiogram","All participants receive a standard 12-lead ECG when they present for follow-up 1 year after completion of anthracycline-based therapy. All participants will also record a 6-lead Kardia (AliveCor, Mountain View, CA, USA) and 1-lead Apple Watch (Apple, Cupertino, CA, USA) ECG with Mayo-owned or participant-owned devices.\n\nLongitudinal participants will receive an Apple Watch to use during this study if they do not have their own (and agree to download the app) and will be able to transmit ECGs anytime anywhere from their Apple Watch from before the initiation, all through the treatment, up to 1-year after anthracycline-based therapy. For validation, these participants will transmit ECGs from their smart watch at the time of routine follow-up visits (at 3-, 6- \\& 9-months post therapy visits) along with 6-lead Kardia ECGs, and 12-lead standard ECGs.",[34,35],"Cross-sectional Arm","Longitudinal Arm",[37,38],"ECG","EKG",{"type":30,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"Echocardiogram","All participants will have an echocardiogram as part of standard of care when they present for their follow-up 1 year after completion of anthracycline-based therapy.",[34,35],[44,45,46],"echo","cardiac ultrasound","heart ultrasound",{"type":30,"name":48,"description":49,"armGroupLabels":50,"otherNames":51},"LVEF echocardiogram","Participants will undergo a limited LVEF echocardiogram at the 6-month post therapy visit.",[34,35],[52,53],"Left ventricular ejection fraction (LVEF) echocardiogram","LVEF echo",{"type":13,"name":55,"description":56,"armGroupLabels":57},"Apple Watch","Longitudinal participants will receive an Apple Watch to use during this study if they do not have their own (and agree to download the app) and will be able to transmit ECGs anytime anywhere from their Apple Watch from before the initiation, all through the treatment, up to 1-year after anthracycline-based therapy. For validation, these participants will transmit ECGs from their smart watch at the time of routine follow-up visits (at 3-, 6- \\& 9-months post therapy visits) along with 6-lead Kardia ECGs, and 12-lead standard ECGs.\n\nLongitudinal participants will be asked to transmit weekly cardio fitness (estimates of peak VO2) from baseline to 1-year post therapy.",[35],{"type":30,"name":59,"description":60,"armGroupLabels":61,"otherNames":62},"Biospecimen collection","Undergo blood draw",[34,35],[63],"Blood draw",{"type":13,"name":65,"description":66,"armGroupLabels":67},"Questionnaires","Participants fill out 2 questionnaires: 1) the Kansas City Cardiomyopathy-12 (KCCQ-12) Questionnaire, and 2) the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) ore 30 (EORTC QLQ-C30) to evaluate health related quality of life and heart failure symptoms.",[34,35],{"type":13,"name":69,"description":70,"armGroupLabels":71,"otherNames":72},"Cardio-pulmonary exercise test","Undergo CPET to assess the response of heart and lungs to exercise.",[35],[73],"CPET",{"type":13,"name":75,"description":76,"armGroupLabels":77,"otherNames":78},"6 minute walk test","Complete a 6MWT, to see how far participants can walk on a hard, flat surface for 6 minutes",[35],[79],"6MWT",{"type":13,"name":81,"description":82,"armGroupLabels":83},"Grip strength test","A hand-held device called a dynamometer will be used to measure the muscle strength in hand\u002Fforearm",[35],[85,89,92],{"measure":86,"description":87,"timeFrame":88},"Detection of left left ventricular ejection fraction (LVEF) \u003C50% by AI-ECG","Mobile device ECGs will be compared to standard 12-lead clinic ECGs for the AI algorithm to predict a reduced EF (EF \\\u003C50%).","Baseline to 1 year follow-up",{"measure":90,"description":91,"timeFrame":88},"Change in AI-ECG based probability of an LVEF \u003C50% using mobile device ECGs","The change in probability of abnormal LVEF by AI-ECG using mobile device ECG will be compared between patients who do develop a reduction in LVEF over time versus those who do not.",{"measure":93,"description":94,"timeFrame":88},"Change in peak VO2","Volume of Oxygen (VO2) will be estimated by the Apple Watch algorithm (developed by Apple Inc.) and reviewed for change from baseline to 1 year.",[],"ALL","18 Years",{"inclusion":99,"exclusion":102,"raw_text":106},[100,101],"ability to understand study procedures and being willing to comply with them for the entire study length","diagnosis of lymphoma or sarcoma with new start or 1 year after completion of anthracycline therapy",[103,104,105],"LVEF \\\u003C50% at baseline, or prior confirmed history of heart failure, persistent atrial fibrillation, left bundle branch block, or paced rhythm","Unwilling or unable to give written informed consent","Participants who have opted out of the Minnesota Research Authorization","Inclusion Criteria:\n\n* ability to understand study procedures and being willing to comply with them for the entire study length\n* diagnosis of lymphoma or sarcoma with new start or 1 year after completion of anthracycline therapy\n\nExclusion Criteria:\n\n* LVEF \\\u003C50% at baseline, or prior confirmed history of heart failure, persistent atrial fibrillation, left bundle branch block, or paced rhythm\n* Unwilling or unable to give written informed consent\n* Participants who have opted out of the Minnesota Research Authorization",[108,109],"ADULT","OLDER_ADULT",[111],{"facility":112,"status":7,"city":113,"state":114,"zip":115,"country":116,"contacts":117,"geoPoint":130},"Mayo Clinic in Rochester","Rochester","Minnesota","55905","United States",[118,123,127],{"name":119,"role":120,"phone":121,"email":122},"Tera Peck","CONTACT","507-538-7425","Peck.Tera@mayo.edu",{"name":124,"role":120,"phone":125,"email":126},"Clinical Trials Referral Office","855-776-0015","mayocliniccancerstudies@mayo.edu",{"name":128,"role":129},"Joerg Herrmann, MD","PRINCIPAL_INVESTIGATOR",{"lat":131,"lon":132},44.02163,-92.4699,[134,136],{"name":119,"role":120,"phone":135,"email":122},"507-266-2123",{"name":124,"role":120,"phone":125,"email":126},[138],{"name":128,"affiliation":12,"role":129},[],[141],{"label":142,"url":143},"Mayo Clinic Clinical Trials","https:\u002F\u002Fwww.mayo.edu\u002Fresearch\u002Fclinical-trials",{"nct_id":4,"conditions":145,"biomarkers":146},[18,19],[],{"nct_id":4,"found":148,"summary":149,"prompt_version":159},true,{"design":150,"status":151,"heading":152,"summary":153,"follow_up":154,"word_count":155,"commitments":156,"compensation":157,"drugs_mentioned":158},"This is an interventional study with a planned enrollment of 250 participants. It is not specified if it is randomized or blinded.","completed","WATCH Study: Monitoring Heart Health in Lymphoma and Sarcoma Survivors","This study, called WATCH, is looking at new ways to monitor heart health in people who have had lymphoma or sarcoma and were treated with anthracycline-based therapy. Researchers want to see if using mobile devices like Apple Watches and Kardia devices, along with artificial intelligence (AI)-powered electrocardiograms (ECGs), can reliably detect heart problems early. You would have standard heart tests like echocardiograms and ECGs, and some participants would receive an Apple Watch to use. The study aims to find a cost-effective way to prevent heart failure in cancer survivors. To join, you must be at least 18 years old, have lymphoma or sarcoma, and either be starting anthracycline therapy or be one year past completing it. The study will be considered successful if these mobile devices can detect a heart pumping problem (left ventricular ejection fraction or LVEF) of less than 50% within one year.","Participants will be followed up to one year after completing anthracycline-based therapy.",145,"You would have standard 12-lead ECGs, 6-lead Kardia ECGs, and 1-lead Apple Watch ECGs. You would also have echocardiograms and a limited LVEF echocardiogram, plus blood draws. This would occur from before treatment, throughout treatment, and up to one year after treatment.","Not stated in the trial record.",[31,40,55],"v2"]