Monitoring for CardioToxicity Using WeArable deVices While Undergoing cancEr Treatments (MCT-WAVE) | NCT07776964 | Trialant

Not yet recruitingInterventionalNot ApplicableUpdated Aug 20, 2026

Monitoring for CardioToxicity Using WeArable deVices While Undergoing cancEr Treatments (MCT-WAVE)

Overview

Key facts that identify this study and show where it stands today.

ClinicalTrials.gov ID: NCT07776964
Lead Sponsor: University of MinnesotaOTHER
Overall Status: Not yet recruiting
Study Type: Interventional
Phase: Not Applicable
Enrollment: 72Estimated
Last Update Posted: Aug 20, 2026Actual
Start Date: Sep 1, 2026Estimated
Primary Completion Date: Mar 1, 2028Estimated
Completion Date: Sep 1, 2028Estimated

Description

What the study is about and why it is being run, in the researchers' own words.

Official Title: Monitoring for CardioToxicity Using WeArable deVices While Undergoing cancEr Treatments (MCT-WAVE)
Brief Summary: 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.
Detailed Description

Conditions

The medical conditions and diseases this study investigates.

Cardiotoxicity
Cancer
Cardiac Arrhythmia

Interventions

The treatments and procedures being evaluated in this study.

Mobile Cardiac Telemetry
Wearable Cardiac Monitor

Participation

Who can join this study and the criteria used to decide.

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria:

Diagnosis of breast cancer, hematologic malignancy including leukemia or lymphoma, or multiple myeloma

At least 18 years of age

Capable of understanding and willing to sign a consent form for this study

Exclusion Criteria:

Known allergy to adhesive patches used for ambulatory EKG monitoring

Children

Cognitively challenged individuals

Prisoners

Active service military personnel

Design

How the study is designed and how its participant groups are organized.

Primary Purpose: Diagnostic
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Contacts

The people to reach with questions about this study or how to join it.

Suma Konety, MDContact

shkonety@umn.edu612-625-4465

Locations

Where the study is run and whether each site is currently recruiting.

M Health Fairview Clinics and Surgery Center

Minneapolis, Minnesota 55455, United States

Collaborators

The organizations and people involved in this study.

Lead Sponsor: University of MinnesotaOTHER
Collaborators

Similar Studies

Other registered studies that closely resemble this one.

Cancer patients may develop cardiovascular complications during cancer treatment, including cardiac arrhythmias, cardiac dysfunction, hypertension, heart failure, and other cardiotoxic effects. Early recognition of cardiotoxicity may help inform monitoring strategies and clinical management during and after cancer treatment.

MCT-WAVE is a prospective, single-arm exploratory pilot study enrolling adults with breast cancer, hematologic malignancy, or multiple myeloma. Each participant will receive usual care plus two wearable patch-based cardiac monitoring devices. Mobile cardiac telemetry will be performed using the FDA-cleared Preventice BodyGuardian Mini Plus ambulatory ECG monitor to collect continuous heart rhythm data. A wearable cardiac monitor patch will also be used to record heart sounds using an accelerometer. Data from the wearable cardiac monitor will be collected for offline analysis and will not be used to guide clinical decision-making in this study.

Participants will be screened for eligibility and, after informed consent, will be fitted with the wearable devices. Baseline data will be collected through electronic medical record review, including demographics, medical history, laboratory values, EKG results, echocardiogram results, medications, cancer treatment information, and clinical events. Participants will receive instructions on how to use and return the devices.

The mobile cardiac telemetry device will be worn for 14 consecutive days and will collect near-real-time ECG data. The wearable cardiac monitor will also be worn for 14 days and will collect heart sounds data. Additional device placement may occur at the 6-month and 12-month study visits. Participants will continue to receive all standard-of-care cancer treatment and cardiac monitoring as determined by their clinical care team.

The primary outcome is incident atrial or ventricular arrhythmia detected during the study. Secondary outcomes include the association between heart sounds and echocardiographic findings of systolic or diastolic dysfunction, and the association between heart sounds and cardiac laboratory markers such as high-sensitivity troponin I and NT-proBNP.