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

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.

Study Overview

• Status: Recruiting
• Conditions: Sarcoma; Lymphoma
• Intervention / Treatment: Procedure: Electrocardiogram; Procedure: Echocardiogram; Procedure: LVEF echocardiogram; Procedure: Biospecimen collection; Other: Questionnaires; Other: Apple Watch; Other: Cardio-pulmonary exercise test; Other: 6 minute walk test; Other: Grip strength test

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
• Study Contact Backup: Name: Tera Peck; Phone Number: 507-266-2123; Email: Peck.Tera@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester
      • Principal Investigator: Joerg Herrmann, MD
      • Contact: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
      • Contact: Tera Peck; Phone Number: 507-538-7425; Email: Peck.Tera@mayo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cross-sectional Arm; Lymphoma and sarcoma cancer survivors will be seen at one time point, 1 year after completion of anthracycline-based therapy.	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.; Other Names: ECG; EKG; 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.; Other Names: echo; cardiac ultrasound; heart ultrasound; Procedure: LVEF echocardiogram; Participants will undergo a limited LVEF echocardiogram at the 6-month post therapy visit.; Other Names: Left ventricular ejection fraction (LVEF) echocardiogram; LVEF echo; Procedure: Biospecimen collection; Undergo blood draw; Other Names: 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.
Experimental: Longitudinal Arm; Lymphoma 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.	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.; Other Names: ECG; EKG; 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.; Other Names: echo; cardiac ultrasound; heart ultrasound; Procedure: LVEF echocardiogram; Participants will undergo a limited LVEF echocardiogram at the 6-month post therapy visit.; Other Names: Left ventricular ejection fraction (LVEF) echocardiogram; LVEF echo; Procedure: Biospecimen collection; Undergo blood draw; Other Names: 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: 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.; Other: Cardio-pulmonary exercise test; Undergo CPET to assess the response of heart and lungs to exercise.; Other Names: CPET; Other: 6 minute walk test; Complete a 6MWT, to see how far participants can walk on a hard, flat surface for 6 minutes; Other Names: 6MWT; Other: Grip strength test; A hand-held device called a dynamometer will be used to measure the muscle strength in hand/forearm

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Joerg Herrmann, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2025
• Primary Completion (Estimated): June 29, 2029
• Study Completion (Estimated): June 29, 2029

Study Registration Dates

• First Submitted: July 1, 2025
• First Submitted That Met QC Criteria: July 1, 2025
• First Posted (Actual): July 10, 2025

Study Record Updates

• Last Update Posted (Estimated): October 15, 2025
• Last Update Submitted That Met QC Criteria: October 13, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Connective and Soft Tissue; Hemic and Lymphatic Diseases; Lymphoma; Sarcoma; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Physical Phenomena; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Geological Phenomena; Surveys and Questionnaires; Blood Specimen Collection; Clostridium perfringens epsilon-toxin; Caves
• Other Study ID Numbers: 25-002911 (Other Identifier: Mayo Clinic Institutional Review Board); NCI-2025-04631 (Other Identifier: CTRP (Clinical Trial Reporting Program)); HT94252510309 (Other Grant/Funding Number: Department of Defense)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No