CardiotoxicityNCT07776964
Monitoring for CardioToxicity Using WeArable deVices While Undergoing cancEr Treatments (MCT-WAVE)
A study testing Mobile Cardiac Telemetry and Wearable Cardiac Monitor in people with Cardiotoxicity and Cancer, run by University of Minnesota at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiotoxicity, Cancer, Cardiac Arrhythmia
- What is being tested?
- Mobile Cardiac Telemetry and Wearable Cardiac Monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2026to 1 Sep 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Known allergy to adhesive patches used for ambulatory EKG monitoring
- Children
- Cognitively challenged individuals
- Prisoners
- Active service military personnel
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
M Health Fairview Clinics and Surgery Center
Minneapolis, Minnesota, 55455
Samantha Wansing, 612-625-4465, hoppx054@umn.edu
Suma Konety, MD
About this study
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.
Read the detailed description
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.
- Conditions
- Cardiotoxicity, Cancer, Cardiac Arrhythmia, Left Ventricular Dysfunction, Breast Cancer, Multiple Myeloma
- Being tested
- Mobile Cardiac Telemetry, Wearable Cardiac Monitor
- Keywords
- MCT-WAVE, Mobile cardiac telemetry, Wearable cardiac monitor, Cardio-oncology, Ventricular arrhythmia, Breast cancer
- Medical subject headings
- Cardiotoxicity, Neoplasms, Arrhythmias, Cardiac, Ventricular Dysfunction, Left, Breast Neoplasms, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Cardiac TelemetryDevice
Also called BodyGuardian Mini Plus
Participants will wear the FDA-cleared BodyGuardian Mini Plus mobile cardiac telemetry patch device for continuous ECG monitoring. The device will collect near-real-time heart rhythm data to identify arrhythmias during and following cancer treatment.
Wearable Cardiac MonitorDevice
Also called WCM
Participants will wear an investigational non-significant risk wearable cardiac monitor patch that records heart sounds using an accelerometer. Data from the device will be used for offline analyses and will not be used for clinical decision-making in this study.
| Study group | Role | What they receive |
|---|---|---|
| Mobile Cardiac Telemetry and Wearable Cardiac Monitor With Usual Care | Experimental | Participants with cancer will receive usual care plus mobile cardiac telemetry using the BodyGuardian Mini Plus ambulatory ECG monitor and a wearable cardiac monitor patch to collect heart sounds. Devices will be worn during cancer treatment to collect arrhythmia and cardiac function monitoring data. Receives: Device: Mobile Cardiac Telemetry; Device: Wearable Cardiac Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incident Atrial or Ventricular Arrhythmia
Incident atrial or ventricular arrhythmia detected by mobile cardiac telemetry during and following cancer treatment will be assessed.
Measured: Up to 12 months
Secondary outcomes (4)
Correlation Between Wearable Cardiac Monitor Heart Sound Measures and High-Sensitivity Troponin I
Correlation between heart sound measures collected by the wearable cardiac monitor and high-sensitivity troponin I concentration during the study period.
Measured: Up to 12 months
Correlation Between Wearable Cardiac Monitor Heart Sound Measures and NT-proBNP
Correlation between heart sound measures collected by the wearable cardiac monitor and NT-proBNP concentration during the study period.
Measured: Up to 12 months
Correlation Between Wearable Cardiac Monitor Heart Sound Measures and Left Ventricular Ejection Fraction
Correlation between heart sound measures collected by the wearable cardiac monitor and left ventricular ejection fraction measured by echocardiography during the study period.
Measured: Up to 12 months
Correlation Between Wearable Cardiac Monitor Heart Sound Measures and Echocardiographic Measures of Diastolic Function
Correlation between heart sound measures collected by the wearable cardiac monitor and echocardiographic measures of diastolic function during the study period.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start29 Oct 2026 (estimated)
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiotoxicityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor
- Investigators
- Suma Konety, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07776964
- Sponsor's protocol ID
- CV-2025-33755
- Status last verified
- Oct 2026
- First submitted
- 11 Aug 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes