RecruitingNot ApplicableNCT07058064

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


Sponsor

Mayo Clinic

Enrollment

250 participants

Start Date

Jul 18, 2025

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is using a smartwatch powered by artificial intelligence (AI) to monitor heart function in people with lymphoma or sarcoma who are receiving a type of chemotherapy called anthracyclines, which can sometimes affect the heart. The goal is to detect early signs of heart stress before symptoms appear. **You may be eligible if...** - You have been diagnosed with lymphoma or sarcoma - You are starting anthracycline-based chemotherapy for the first time, OR you completed this type of chemotherapy within the past year - You are able to understand and follow study instructions **You may NOT be eligible if...** - Your heart's pumping function (ejection fraction) is already below 50% before starting the study - You have a prior history of heart failure confirmed by a doctor - You have a condition that makes wearing a wrist monitor impractical or impossible Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREElectrocardiogram

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.

PROCEDUREEchocardiogram

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.

PROCEDURELVEF echocardiogram

Participants will undergo a limited LVEF echocardiogram at the 6-month post therapy visit.

OTHERApple 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.

PROCEDUREBiospecimen collection

Undergo blood draw

OTHERQuestionnaires

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.

OTHERCardio-pulmonary exercise test

Undergo CPET to assess the response of heart and lungs to exercise.

OTHER6 minute walk test

Complete a 6MWT, to see how far participants can walk on a hard, flat surface for 6 minutes

OTHERGrip strength test

A hand-held device called a dynamometer will be used to measure the muscle strength in hand/forearm


Locations(1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

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NCT07058064


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