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

Overview

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.

Interventions

• 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 an
• 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 Kar
• 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

Primary outcome measures

• Detection of left left ventricular ejection fraction (LVEF) <50% by AI-ECG [Time frame: Baseline to 1 year follow-up]
• Change in AI-ECG based probability of an LVEF <50% using mobile device ECGs [Time frame: Baseline to 1 year follow-up]
• Change in peak VO2 [Time frame: Baseline to 1 year follow-up]

Eligibility criteria

Inclusion criteria

• 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 criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Screening

Study locations

United States · 1 center

• Mayo Clinic in Rochester — Rochester

Identifiers

NCT: NCT07058064 · 25-002911 · NCI-2025-04631 · 25-002911 · HT94252510309

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗