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

NCT07058064 | Recruiting

• 3 other identifiers: 25-002911NCI-2025-04631HT94252510309
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Cross-sectional Arm

ACTIVE COMPARATOR

Lymphoma and sarcoma cancer survivors will be seen at one time point, 1 year after completion of anthracycline-based therapy.

Procedure: Electrocardiogram; Procedure: Echocardiogram; Procedure: LVEF echocardiogram; Procedure: Biospecimen collection; Other: Questionnaires

Longitudinal Arm

EXPERIMENTAL

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; 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 test

Interventions

Electrocardiogram PROCEDURE

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.

Also known as: ECG, EKG

Cross-sectional Arm; Longitudinal Arm

Echocardiogram PROCEDURE

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.

Also known as: echo, cardiac ultrasound, heart ultrasound

Cross-sectional Arm; Longitudinal Arm

LVEF echocardiogram PROCEDURE

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

Also known as: Left ventricular ejection fraction (LVEF) echocardiogram, LVEF echo

Cross-sectional Arm; Longitudinal Arm

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.

Longitudinal Arm

Biospecimen collection PROCEDURE

Undergo blood draw

Also known as: Blood draw

Cross-sectional Arm; Longitudinal Arm

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.

Cross-sectional Arm; Longitudinal Arm

Cardio-pulmonary exercise test OTHER

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

Also known as: CPET

Longitudinal Arm

6 minute walk test OTHER

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

Also known as: 6MWT

Longitudinal Arm

Grip strength test OTHER

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

Longitudinal Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Lymphoma; Sarcoma

Interventions

Caves; Blood Specimen Collection; Surveys and Questionnaires; Clostridium perfringens epsilon-toxin

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Connective and Soft Tissue

Intervention Hierarchy (Ancestors)

Geological Phenomena; Physical Phenomena; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Environment and Public Health; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health

Study Officials

• Joerg Herrmann, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tera Peck

CONTACT

507-266-2123; Peck.Tera@mayo.edu

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: July 10, 2025
• Study Start: July 18, 2025
• Primary Completion (Estimated): June 29, 2029
• Study Completion (Estimated): June 29, 2029
• Last Updated: October 15, 2025

Record last verified: 2025-10

Locations

US (1)