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NCT Number: NCT07058064

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.

Recruiting

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: ECG, EKG

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.

Other names: echo, cardiac ultrasound, heart ultrasound

LVEF echocardiogram

Procedure

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

Other names: Left ventricular ejection fraction (LVEF) echocardiogram, LVEF echo

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

Undergo blood draw

Other names: 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

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

Other names: CPET

6 Minute Walk Test

Other

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

Other names: 6MWT

Grip strength test

Other

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

Primary outcomes

  1. Detection of left left ventricular ejection fraction (LVEF) <50% by AI-ECG

    Time frame: 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%).

  2. Change in AI-ECG based probability of an LVEF <50% using mobile device ECGs

    Time frame: 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.

  3. Change in peak VO2

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Tera Peck

CONTACT

[email protected]

507-266-2123

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Jul 10, 2025
Registry last updated
Oct 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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