Wearable Devices for Cardiotoxicity Monitoring in Cancer

SK
SW
Overseen BySamantha Wansing
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Minnesota
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This pilot study will evaluate the validity and feasibility of ambulatory cardiac monitoring to identify markers of cardiotoxicity in adults undergoing cancer treatment.

Participants with breast cancer, hematologic malignancy, or multiple myeloma will receive usual care plus two wearable patch monitors: mobile cardiac telemetry using the BodyGuardian Mini Plus ambulatory ECG monitor and an investigational wearable cardiac monitor that records heart sounds. The study will assess arrhythmias detected by mobile cardiac telemetry and explore whether heart sounds are associated with echocardiographic findings and cardiac biomarkers.

Participants will wear the devices during cancer treatment, with monitoring periods at baseline and possible repeat monitoring at 6-month and 12-month study visits.

Who Is on the Research Team?

SK

Suma Konety, MD

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for adults with breast cancer, blood cancers, or multiple myeloma who are starting or undergoing cancer treatment. Participants must be able to wear heart monitoring devices during their therapy.

Inclusion Criteria

I understand the study and am willing to sign the consent form.
I am at least 18 years old.
I have been diagnosed with breast cancer or a blood cancer like leukemia, lymphoma, or myeloma.

Exclusion Criteria

Active service military personnel
I have cognitive or intellectual challenges.
I am a child.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Baseline Monitoring

Participants are fitted with wearable devices and baseline data is collected

2 weeks
1 visit (in-person)

Cancer Treatment Monitoring

Participants wear devices during cancer treatment to monitor cardiac function

14 days
Continuous monitoring

Follow-up Monitoring

Additional device placement and monitoring at 6-month and 12-month visits

Up to 12 months
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Trial Overview

The study tests if wearable heart monitors can safely and effectively detect early signs of heart problems in people receiving cancer treatments. Participants will use two types of patch monitors at different times during their care.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Mobile Cardiac Telemetry and Wearable Cardiac Monitor With Usual CareExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials
1,459
Recruited
1,623,000+

Boston Scientific Corporation

Industry Sponsor

Trials
758
Recruited
867,000+
Michael F. Mahoney profile image

Michael F. Mahoney

Boston Scientific Corporation

Chief Executive Officer since 2016

MBA from Wake Forest University, BBA in Finance from the University of Iowa

Kenneth Stein profile image

Kenneth Stein

Boston Scientific Corporation

Chief Medical Officer since 2020

MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology