NCT07058064

WATCH (Wearable Artificial inTelligence for Cardiac Function and Health Monitoring)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lymphoma
• Sarcoma

Interventions

Type	Name	Description
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. 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.
PROCEDURE	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.
PROCEDURE	LVEF echocardiogram	Participants will undergo a limited LVEF echocardiogram at the 6-month post therapy visit.
OTHER	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. Longitudinal participants will be asked to transmit weekly cardio fitness (estimates of peak VO2) from baseline to 1-year post therapy.
PROCEDURE	Biospecimen collection	Undergo blood draw
OTHER	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.
OTHER	Cardio-pulmonary exercise test	Undergo CPET to assess the response of heart and lungs to exercise.
OTHER	6 minute walk test	Complete a 6MWT, to see how far participants can walk on a hard, flat surface for 6 minutes
OTHER	Grip strength test	A hand-held device called a dynamometer will be used to measure the muscle strength in hand/forearm

Timeline

• Start date: 2025-07-18
• Primary completion: 2029-06-29
• Completion: 2029-06-29
• First posted: 2025-07-10
• Last updated: 2025-10-15

Locations

1 site across 1 country: United States