WATCH (Wearable Artificial inTelligence for Cardiac Function and Health Monitoring)
NCT ID: NCT07058064
Last Updated: 2025-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
250 participants
INTERVENTIONAL
2025-07-18
2029-06-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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Cross-sectional Arm
Lymphoma and sarcoma cancer survivors will be seen at one time point, 1 year after completion of anthracycline-based therapy.
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.
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.
LVEF echocardiogram
Participants will undergo a limited LVEF echocardiogram at the 6-month post therapy visit.
Biospecimen collection
Undergo blood draw
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.
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.
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.
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.
LVEF echocardiogram
Participants will undergo a limited LVEF echocardiogram at the 6-month post therapy visit.
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.
Biospecimen collection
Undergo blood draw
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.
Cardio-pulmonary exercise test
Undergo CPET to assess the response of heart and lungs to exercise.
6 minute walk test
Complete a 6MWT, to see how far participants can walk on a hard, flat surface for 6 minutes
Grip strength test
A hand-held device called a dynamometer will be used to measure the muscle strength in hand/forearm
Interventions
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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.
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.
LVEF echocardiogram
Participants will undergo a limited LVEF echocardiogram at the 6-month post therapy visit.
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.
Biospecimen collection
Undergo blood draw
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.
Cardio-pulmonary exercise test
Undergo CPET to assess the response of heart and lungs to exercise.
6 minute walk test
Complete a 6MWT, to see how far participants can walk on a hard, flat surface for 6 minutes
Grip strength test
A hand-held device called a dynamometer will be used to measure the muscle strength in hand/forearm
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* diagnosis of lymphoma or sarcoma with new start or 1 year after completion of anthracycline therapy
Exclusion Criteria
* Unwilling or unable to give written informed consent
* Participants who have opted out of the Minnesota Research Authorization
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Joerg Herrmann, MD
Principal Investigator
Principal Investigators
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Joerg Herrmann, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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NCI-2025-04631
Identifier Type: OTHER
Identifier Source: secondary_id
25-002911
Identifier Type: OTHER
Identifier Source: secondary_id
HT94252510309
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
25-002911
Identifier Type: -
Identifier Source: org_study_id
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