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

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Mayo Clinic

Status

Enrolling

Conditions

Sarcoma
Lymphoma

Treatments

Other: 6 minute walk test
Procedure: Echocardiogram
Procedure: Electrocardiogram
Procedure: Biospecimen collection
Other: Grip strength test
Other: Apple Watch
Other: Questionnaires
Other: Cardio-pulmonary exercise test
Procedure: LVEF echocardiogram

Study type

Interventional

Funder types

Other

Identifiers

NCT07058064
25-002911 (Other Identifier)
HT94252510309 (Other Grant/Funding Number)
NCI-2025-04631 (Other Identifier)

Details and patient eligibility

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. 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.

Enrollment

250 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Screening

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

250 participants in 2 patient groups

Cross-sectional Arm
Active Comparator group
Description:
Lymphoma and sarcoma cancer survivors will be seen at one time point, 1 year after completion of anthracycline-based therapy.
Treatment:
Procedure: LVEF echocardiogram
Other: Questionnaires
Procedure: Biospecimen collection
Procedure: Echocardiogram
Procedure: Electrocardiogram
Longitudinal Arm
Experimental group
Description:
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.
Treatment:
Procedure: LVEF echocardiogram
Other: Cardio-pulmonary exercise test
Other: Questionnaires
Other: Grip strength test
Other: Apple Watch
Procedure: Biospecimen collection
Procedure: Echocardiogram
Procedure: Electrocardiogram
Other: 6 minute walk test

Trial contacts and locations

1

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Central trial contact

Tera Peck; Clinical Trials Referral Office

Data sourced from clinicaltrials.gov

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