WATCH (Wearable Artificial inTelligence for Cardiac Function and Health Monitoring)
Mayo Clinic
250 participants
Jul 18, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria2
- 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
Exclusion Criteria3
- LVEF <50% 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
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Interventions
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. Longitudinal participants will be asked to transmit weekly cardio fitness (estimates of peak VO2) from baseline to 1-year post therapy.
Undergo blood draw
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.
Undergo CPET to assess the response of heart and lungs to exercise.
Complete a 6MWT, to see how far participants can walk on a hard, flat surface for 6 minutes
A hand-held device called a dynamometer will be used to measure the muscle strength in hand/forearm
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. 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.
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.
Participants will undergo a limited LVEF echocardiogram at the 6-month post therapy visit.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07058064