NCT07058064 · Mayo Clinic
WATCH (Wearable Artificial inTelligence for Cardiac Function and Health Monitoring)
What this study is about
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.
View original scientific description
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 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.
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 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.
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
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
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.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Rochester, Minnesota
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 15, 2025 · Source of record for eligibility and locations