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

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.

• Mobile Cardiac Telemetry (Device), also known as 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 Monitor (Device), also known as 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.

Primary outcomes

• Incident Atrial or Ventricular Arrhythmia [Up to 12 months]: Incident atrial or ventricular arrhythmia detected by mobile cardiac telemetry during and following cancer treatment will be assessed.

Secondary outcomes

• Correlation Between Wearable Cardiac Monitor Heart Sound Measures and High-Sensitivity Troponin I [Up to 12 months]: Correlation between heart sound measures collected by the wearable cardiac monitor and high-sensitivity troponin I concentration during the study period.
• Correlation Between Wearable Cardiac Monitor Heart Sound Measures and NT-proBNP [Up to 12 months]: Correlation between heart sound measures collected by the wearable cardiac monitor and NT-proBNP concentration during the study period.
• Correlation Between Wearable Cardiac Monitor Heart Sound Measures and Left Ventricular Ejection Fraction [Up to 12 months]: Correlation between heart sound measures collected by the wearable cardiac monitor and left ventricular ejection fraction measured by echocardiography during the study period.
• Correlation Between Wearable Cardiac Monitor Heart Sound Measures and Echocardiographic Measures of Diastolic Function [Up to 12 months]: Correlation between heart sound measures collected by the wearable cardiac monitor and echocardiographic measures of diastolic function during the study period.

Sex: All, ages: 18 Years to any

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

• Suma Konety, MD, Principal investigator, University of Minnesota