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

NCT07058064 — Not applicable, Recruiting, 250 participants, Mayo Clinic

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RegistryNCT07058064
StatusRecruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, screening
Enrollment250 (Estimated)
SponsorMayo Clinic (Other)
ConditionsLymphoma, Sarcoma
InterventionsElectrocardiogram, Echocardiogram, LVEF echocardiogram, Apple Watch, Biospecimen collection, Questionnaires, Cardio-pulmonary exercise test, 6 minute walk test, Grip strength test (Procedure, other)
Datesstart 2025-07-18, primary completion 2029-06-29 (estimated), completion 2029-06-29 (estimated), first posted 2025-07-10, last updated 2025-10-15
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Lymphoma All trials for Sarcoma All trials of Electrocardiogram All trials of Echocardiogram

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Cross-sectional ArmActive comparatorProcedure: Electrocardiogram; Procedure: Echocardiogram; Procedure: LVEF echocardiogram; Procedure: Biospecimen collection; Other: QuestionnairesLymphoma and sarcoma cancer survivors will be seen at one time point, 1 year after completion of anthracycline-based therapy.
Longitudinal ArmExperimentalProcedure: Electrocardiogram; Procedure: Echocardiogram; Procedure: LVEF echocardiogram; Other: Apple Watch; Procedure: Biospecimen collection; Other: Questionnaires; Other: Cardio-pulmonary exercise test; Other: 6 minute walk test; Other: Grip strength testLymphoma and sarcoma cancer survivors will be seen before the start of anthracycline-based therapy and followed every three months up to 1 year after completion of therapy. Longitudinal participants will have the option of recording ECG and cardio fitness data through an Apple Watch from before up to 1 year post anthracycline treatment.
  • Electrocardiogram (Procedure), also known as ECG, EKG: 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.
  • Echocardiogram (Procedure), also known as echo, cardiac ultrasound, heart ultrasound: 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.
  • LVEF echocardiogram (Procedure), also known as Left ventricular ejection fraction (LVEF) echocardiogram, LVEF echo: Participants will undergo a limited LVEF echocardiogram at the 6-month post therapy visit.
  • Apple Watch (Other): 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.
  • Biospecimen collection (Procedure), also known as Blood draw: Undergo blood draw
  • Questionnaires (Other): 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.
  • Cardio-pulmonary exercise test (Other), also known as CPET: Undergo CPET to assess the response of heart and lungs to exercise.
  • 6 minute walk test (Other), also known as 6MWT: Complete a 6MWT, to see how far participants can walk on a hard, flat surface for 6 minutes
  • Grip strength test (Other): A hand-held device called a dynamometer will be used to measure the muscle strength in hand/forearm

+Outcome measures

Primary outcomes

  • Detection of left left ventricular ejection fraction (LVEF) <50% by AI-ECG [Baseline to 1 year follow-up]: Mobile device ECGs will be compared to standard 12-lead clinic ECGs for the AI algorithm to predict a reduced EF (EF <50%).
  • Change in AI-ECG based probability of an LVEF <50% using mobile device ECGs [Baseline to 1 year follow-up]: 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.
  • Change in peak VO2 [Baseline to 1 year follow-up]: 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.

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

FacilityCityCountryStatus
Mayo Clinic in RochesterRochester, MinnesotaUnited StatesRecruiting

+Investigators