BMAD Trial: Use of data from μCor, A Novel Wearable Sensor, reduces HF readmissions following a recent HF hospitalization

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By Alberto Castro on

Key Points:

 

  • The μCor monitor is a novel device that uses radiofrequency signals to assess the wearer’s thoracic fluid index, which can indicate HF complications.
  • The BMAD trial enrolled 522 patients with HF within 10 days of hospitalization and fitted them with the μCor monitor, which was worn continuously for 90 days.
  • Results showed that patients whose clinicians monitored their thoracic fluid index using the μCor device had a 38% relative risk reduction compared to those in the control arm.

The BMAD trial suggests that a novel device called the μCor monitor may help reduce hospital readmissions in patients with HF. The μCor monitor is a sensor that uses radiofrequency signals to assess the wearer’s thoracic fluid index, which is a measure of how much fluid is in the lungs. The device can alert clinicians if the patient’s thoracic fluid level crosses a threshold that may indicate HF complications.

 

This study is a multicenter, multinational prospective concurrent control clinical trial consisting of two arms named BMAD HF (control arm) and BMAD Tx (intervention arm). The investigation aims to assess the potential benefits of Microcor in patients with acute decompensated heart failure. The intervention arm, BMAD Tx, involves using radar-directed therapy along with the Microcor device, while the control arm, BMAD HF, only uses the Microcor device

 

Patients included in the study had to have a prior hospitalization for heart failure within 10 days prior and a heart failure event within 6 months, Heart failure event was defined  as hospitalization, emergency room visit, observation unit visit, or unplanned clinic visit where medical theraoy was asjusted or administered. The trial enrolled 522 patients and they were fitted with the μCor monitor, which was worn continuously for 90 days. Half of the patients (n=257) had their information from the monitor sent to their clinician, while the other half served as a control group and did not have their data sent to their clinician.

 

The primary aim of the study was to determine the probability of patients being readmitted to the hospital due to HF complications within 90 days. The results revealed that patients whose thoracic fluid index was monitored using the μCor device by their clinicians showed a 38% relative risk reduction (p=0.03) when compared to those who did not have their data monitored. The absolute risk reduction was 7% at 90 days, and the number of patients who needed to be treated with the device to prevent one readmission was 14.3.

 

In addition to reducing hospital readmissions, the study also found that patients in the intervention arm reported an average increase in quality of life 12-points higher than patients in the control group (p=0.004). Both arms experienced an average improvement in quality of life over the 90 days, but the intervention arm reported a greater improvement.

 

Overall, the μCor monitor appears to be a promising tool for reducing hospital readmissions and improving quality of life in patients with HF. The device is non-invasive and can be worn continuously, allowing for real-time monitoring of thoracic fluid levels. Clinicians can receive alerts if the patient’s fluid level crosses a threshold, enabling them to intervene before the patient experiences HF complications. Further research is needed to confirm these findings and explore the potential of the μCor monitor in other patient populations.