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

Not Applicable

Not yet recruiting

• Conditions: Lymphoma; Sarcoma

• Registration Number: NCT07058064
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study Start: 2025-07-01
• Study First Submitted: 2025-07-01
• Study First Submitted QC: 2025-07-01
• Last Update Submitted: 2025-07-01
• Study First Posted: 2025-07-10
• Last Update Posted: 2025-07-10
• Primary Completion: 2029-06-29
• Study Completion: 2029-06-29

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States