Benefits of Microcor in Ambulatory Decompensated Heart Failure (BMAD-TX)

To assess investigator engagement of μCor system data in the context of heart failure management. The μCor system includes a sensor and wearable patch for fluid management.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Device: μCor

Detailed Description

Subjects meeting the inclusion/exclusion criteria will wear the μCor for up to 90 days.

During the study, face to face follow up will occur every 30 days. For all subjects, each scheduled clinic visit will include assessment of cardiac signs, symptoms, and any relevant clinically actionable events.

The subject will be given a daily diary to track symptoms, hospital visits, medication changes, and all other heart failure related clinical events.

Weekly phone calls to the subject will be given throughout the duration of the study to remind the patient to use the subject diary and to collect and record heart failure related clinical events.

The subject's health care provider team will receive the μCor data through access to a clinical tool interface. The clinical tool will send data updates that are dependent on the μCor data trends. The data updates will allow the health care provider team to take action when the data indicate worsening heart failure, within the context of standard of care medical practice and patient specific parameters. Weekly data reports will be delivered to the investigators.

Subjects will be contacted six months and one year from initial enrollment to assess the vital status of the subject, any heart failure related clinical events since the end of μCor wear, and any health care utilization since the end of μCor wear.

• Study Type: Interventional
• Enrollment (Actual): 265
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Klagenfurt, Austria, 9020
    • Klinikum Klagenfurt am Wörthersee
  • Wien, Austria, 1100
    • Klinik Favoriten
• France
  • Lille, France, 59037
    • Centre Hospitalier Régional Universitaire de Lille - Hôpital Cardiologique
  • Montpellier, France, 34295
    • CHU Montpellier - Hôpital Arnaud de Villeneuve
  • Montpellier, France
    • CHU Montpellier - Hôpital Arnaud de Villeneuve
  • Paris, France, 75015
    • Hôpital Européen Georges Pompidou - Centre d'Investigations Cliniques - Pôle D - étage 5
  • Paris, France
    • Hôpital Européen Georges Pompidou - Centre d'Investigations Cliniques - Pôle D - étage 5
• Germany
  • Bad Nauheim, Germany
    • Kerckhoff-Klinik GmbH
  • Bad Nauheim, Germany, 06032
    • Kerckhoff-Klinik GmbH
  • Frankfort, Germany, 60590
    • Universitätsklinikum Frankfurt
  • Gießen, Germany, 35392
    • Universitätsklinikum Gießen und Marburg GmbH
  • Hamburg, Germany
    • Albertinen Krankenhaus Hamburg
  • Hannover, Germany, 30625
    • Medizinische Hochschule Hannover
  • Hannover, Germany
    • Medizinische Hochschule Hannover
  • Leipzig, Germany, 4289
    • Herzzentrum Leipzig, Universitätsklinik für Kardiologie Abteilung Rhythmologie
  • GG
    • Hamburg, GG, Germany, 22457
      • Albertinen Krankenhaus HH
• United States
  • Alabama
    • Sheffield, Alabama, United States, 35660
      • Syed Research Consultants LLC
  • California
    • El Cajon, California, United States, 92020
      • TriWest Research
    • Inglewood, California, United States, 90301
      • Zillan Clinical Research
    • Los Angeles, California, United States, 90036
      • Axis Clinical Trials
    • Mission Hills, California, United States, 91345
      • Invivocure LLC
    • San Diego, California, United States, 92119
      • ACRC Studies
  • Florida
    • Aventura, Florida, United States, 33180
      • Aventura Clinical Research LLC
    • Davenport, Florida, United States, 33837
      • Accel Research Sites - Guardian
    • DeLand, Florida, United States, 32720
      • Accel Research Sites- Daytona Heart Group
    • Deltona, Florida, United States, 32725
      • Accel Research Sites - Guardian Winter Park
    • Fort Lauderdale, Florida, United States, 33308
      • Holy Cross Hospital, Medical Group, Cardiology Associates
    • Hialeah, Florida, United States, 33013
      • Inpatient Research Clinic
    • Hialeah, Florida, United States, 33013
      • Elite Cardiac Research Center
    • Miami, Florida, United States, 33155
      • Westchester Research Center at Westchester General Hospital
    • Miami, Florida, United States, 32032
      • Homestead Associates in Research
    • North Miami, Florida, United States, 33169
      • Miramax Clinical Research Inc
    • Ocala, Florida, United States, 34471
      • Ocala Cardiovascular Research
    • Orlando, Florida, United States, 32837
      • Accel Research Sites
    • Tamarac, Florida, United States, 33321
      • DBC Research
    • Winter Haven, Florida, United States, 33880
      • Winter Haven Hospital - BayCare Health System
    • Winter Park, Florida, United States, 32792
      • Accel Research Sites - Guardian Winter Park
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Emory University School of Medicine
    • Columbus, Georgia, United States, 31904
      • Columbus Cardiology Associates
    • Eatonton, Georgia, United States, 31024
      • Accel Research Sites - Lake County Medical Group
  • Illinois
    • Quincy, Illinois, United States, 62301
      • Quincy Medical Group
  • Indiana
    • Munster, Indiana, United States, 46321
      • Cardiovascular Research of Northwest Indiana, LLC
    • Richmond, Indiana, United States, 47374
      • Reid Physician Associates
    • South Bend, Indiana, United States, 46601
      • Beacon Medical Group
  • Kentucky
    • Louisville, Kentucky, United States, 40205
      • Norton Heart Specialists
    • Owensboro, Kentucky, United States, 42303
      • Research Integrity, LLC
  • Louisiana
    • Hammond, Louisiana, United States, 70403
      • Heart Clinic of Hammond
  • Maryland
    • Baltimore, Maryland, United States, 21784
      • Sinai Center for Thrombosis Reserach and Drug Development
    • Pembroke Hills, Maryland, United States, 33024
      • Intervent Clinical Research Center
    • Salisbury, Maryland, United States, 21804
      • Peninsula Regional Medical Center
  • Michigan
    • Rochester, Michigan, United States, 48307
      • Ascension Providence Rochester Hospital
    • Saginaw, Michigan, United States, 48601
      • Ascension St. Mary's Research Institute
  • Mississippi
    • Jackson, Mississippi, United States, 48601
      • Jackson Heart Clinic
  • Missouri
    • Lee's Summit, Missouri, United States, 64064
      • Kansas City Cardiology
    • Saint Louis, Missouri, United States, 63136
      • St. Louis Heart and Vascular
    • Saint Louis, Missouri, United States, 63128
      • Gateway Cardiovascular Research Center, Inc
  • Nebraska
    • Lincoln, Nebraska, United States, 68506
      • Bryan Heart
    • Omaha, Nebraska, United States, 68114
      • Methodist Physicians Clinical Heart Consultants
  • New Jersey
    • Cherry Hill, New Jersey, United States, 08034
      • Virtua Health
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center
    • Neptune, New Jersey, United States, 07753
      • Jersey Shore University Medical Center
  • New York
    • Bronx, New York, United States, 10457
      • BronxCare Health System at BronxCare Hospital Center
    • Cooperstown, New York, United States, 13326
      • Bassett Medical Center
    • Rosedale, New York, United States, 11422
      • Laurelton Heart Specialist
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • Macklenberg Heart Specialists / Focus Clinical Research Solutions
  • Ohio
    • Springfield, Ohio, United States, 45504
      • Heart House Research Foundation
    • Toledo, Ohio, United States, 43608
      • Mercy Health St. Vincent Medical Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Integris Baptist Medical Center
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Health Milton S. Hershey Medical Center
    • Newtown, Pennsylvania, United States, 18940
      • Mercer Bucks Cardiology at Jefferson Health
    • Pittsburgh, Pennsylvania, United States, 15212
      • Cardiovascular Institute
    • Smithfield, Pennsylvania, United States, 15478
      • Frontier Clinical Research, LLC
  • South Carolina
    • Lancaster, South Carolina, United States, 77598
      • Carolina Heart Specialists
  • Tennessee
    • Knoxville, Tennessee, United States, 37934
      • Knoxville HMA Cardiology, PPM, LLC
  • Texas
    • Allen, Texas, United States, 75013
      • North Texas Research Associates
    • Cypress, Texas, United States, 77429
      • North Houston Cardiology Center
    • Fort Worth, Texas, United States, 76104
      • JPS Health Network
    • McKinney, Texas, United States, 75071
      • North Texas Research Associates
    • McKinney, Texas, United States, 75071
      • Texas Institute Of Cardiology
    • New Braunfels, Texas, United States, 78130
      • Mission Research Institue
    • Webster, Texas, United States, 77598
      • Bay Area Heart
  • Virginia
    • Lynchburg, Virginia, United States, 24501
      • Stroobants Cardiovascular Center
  • Washington
    • Puyallup, Washington, United States, 98372
      • Pulse Heart Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 4.1.1 Subjects hospitalized for acute decompensated heart failure and enrolled in the study within 10 days post-hospital discharge.
• 4.1.2 Subjects who have had an acute heart failure event requiring medical management in the previous 180 days of index hospitalization admission. This acute heart failure event admission must be at least 2 weeks apart from the event admission in 4.1.1
• 4.1.3 Subjects 21 years of age or older on the day of screening.

Exclusion Criteria:

• 4.2.1 Subjects who are wearing the wearable cardioverter defibrillator (WCD)
• 4.2.2 Subjects not expected to survive one year from enrollment from non-cardiac disease.
• 4.2.3 Subjects with skin allergy or sensitivity to medical adhesives.
• 4.2.4 Subjects anticipated to start dialysis within 90 days.
• 4.2.5 Subjects currently implanted with an subcutaneous implantable cardio defibrillator (S-ICD) system.
• 4.2.6 Subjects who received a percutaneous coronary intervention (PCI) less than 24 hours after onset of heart failure related symptoms during index hospitalization.
• 4.2.7 Subjects who are unable to participate in all follow up visits.
• 4.2.8 Subjects participating in research other than a registry at the time of enrollment.
• 4.2.9 Subjects currently implanted with a Left Ventricular Assist Device (LVAD).
• 4.2.10 Subjects with self-reported pregnancy.
• 4.2.11 Subjects currently being actively managed with any device based remote HF monitoring.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Device Data Engagement Assessment; This arm will assess the endpoints of investigator engagement with the device data.	Device: μCor; μCor consists of the following components: A) Patch B) Sensor C) Charger D) Data transmission device (Gateway) E) Server Once activated, the wearable Sensor automatically acquires ECG, RF readings, heart rate, respiration rate, activity, and posture measurements.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Data Updates Received by the uCor Subject Management System	Each time a subject's thoracic fluid index (TFI) exceeded a threshold for 3 consecutive days, a data update report was generated by the uCor management system. The site then confirmed its receipt of the data update by completing a case report form. At least 1 of these case report forms was completed for 56 subjects.	90 days
Approximate Time Spent Reviewing Data Reports Assessment Across Sites (PO 2: Part 1/2)	Sites reviewed data reports in each of the following contexts: planned weekly phone call, planned office visit, unplanned phone call, unplanned office visit, and data update. Sites reported whether they spent less than 5, 5 to 10, or greater than 10 minutes reviewing each report. At least 1 of these case report forms was completed for 214 subjects.	90 days
Approximate Time Spent Reviewing Data Reports Assessment Within Sites (PO 2: Part 2/2)	Sites reviewed data reports in each of the following contexts: planned weekly phone call, planned office visit, unplanned phone call, unplanned office visit, and data update. Sites reported whether they spent less than 5, 5 to 10, or greater than 10 minutes reviewing each report. At least 1 of these case report forms was completed for 214 subjects.	90 days
The Number of Medication Changes(MC) and Lifestyle Modifications(LS) Recommended to the Subject Based on Evaluating μCor Data and Symptoms (PO 3: Part 1/3)	Sites reviewed data reports in each of the following contexts: planned weekly phone call, planned office visit, unplanned phone call, unplanned office visit, and data update. In each context, the subject was asked whether their symptoms changed. If yes, the site reported in a case report form whether it took action to treat the subject in the form of a medication change or lifestyle modification. At least one of these case report forms (CRFs) was completed for 214 subjects	90 days
The Number of Medication Changes(MC) and Lifestyle Modifications(LS) Recommended to the Subject Based on Evaluating μCor Data and Symptoms (PO 3: Part 2/3)	Sites reviewed data reports in each of the following contexts: planned weekly phone call, planned office visit, unplanned phone call, unplanned office visit, and data update. In each context, the subject was asked whether their symptoms changed. If yes, the site reported in a case report form whether it took action to treat the subject in the form of a medication change or lifestyle modification. At least one of these case report forms (CRFs) was completed for 214 subjects.	90 days
The Number of Medication Changes(MC) and Lifestyle Modifications(LS) Recommended to the Subject Based on Evaluating μCor Data and Symptoms (PO 3: Part 3/3)	Sites reviewed data reports in each of the following contexts: planned weekly phone call, planned office visit, unplanned phone call, unplanned office visit, and data update. In each context, the subject was asked whether their symptoms changed. If yes, the site reported in a case report form whether it took action to treat the subject in the form of a medication change or lifestyle modification. At least one of these case report forms (CRFs) was completed for 214 subjects	90 days
The Number of Medication Changes Based on Subject Incidental Findings	During weekly planned phone calls, planned office visits, and unplanned office visits, sites asked subjects whether they underwent any changes to their heart failure and/or cardiac medications since the last phone call and reported the result in a case report form. At least 1 of these case report forms was completed for 241 subjects.	90 days
Number of Times High μCor Measurements Were Reduced Below Threshold Levels After Medication Was Titrated or Lifestyle Modifications Were Recommended	482 medication changes or lifestyle (MC/LS) modifications occurred within the first 90 days of the study. To include only medication changes preceded and followed by sufficient µCor data to determine a threshold crossing, medication changes within the first 2 weeks of the study or the final 3 weeks of device wear were discarded. This resulted in in 262 analyzable changes. Changes occurring within 1 week of another change were grouped together. This resulted in 192 change events. Time windows were defined as 0-13 days before the first change in a change event vs. 8-21 days after the last change in a change event. A high μCor measurement was defined as the receipt of a data update by the site. A low μCor measurement was defined as the absence of a data update received by the site.	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Strength of Association Between μCor Measurements and Clinically Related Heart Failure Events.	Definitions: Daytime: 7:00 AM - 12:00 AM Nighttime: 12:00 AM - 7:00 AM For each day on which the subject wore the device, the following values were calculated: Daytime activity: The proportion of minutes while wearing the device that the subject spent active (unitless). Nighttime heart rate: The median heart rate while wearing the device during the night (beats/min) Thoracic fluid index: The median proportion of ratio of radiofrequency-measured lung fluid readings compared to the subject's baseline (unitless). Nighttime posture: The median pitch angle while wearing the device during the night (degrees, where 0 is the horizontal). Nighttime respiration: The median respiration rate while wearing the device during the night (breaths/min) HF event: a hospitalization, emergency room visit, observation unit visit, unplanned clinic visit, or death primarily due to heart failure.	90 days
Strength of Association Between μCor Measurements and Subject Reported Symptoms	During office visits at months 1, 2, and 3, subjects reported their degrees of dyspnea, orthopnea, and fatigue on the following scale: [none, seldom, frequent, continuous]. Each day that the subject wore the device, a daily median was calculated for the following measures: [thoracic fluid index, nighttime heart rate, nighttime respiration rate]. Nighttime was defined as 12:00 AM - 7:00 AM.	90 days
Correlations Between uCor Measurements and Patient Reported Symptoms: Mild/Severe Symptoms	During office visits at months 1, 2, and 3, subjects reported their degrees of dyspnea, orthopnea, and fatigue on the following scale: [none, seldom, frequent, continuous].	90 days
Hospital Readmission Rate, Physician Visit Rate, and Outpatient Clinic Visit Rate During the Study Period	For each weekly phone call and monthly office visit, each subject reported whether they experienced a hospitalization or emergency room visit since their last call/visit. An adjudication committee of physicians determined whether each event was due to HF or not.	90 days
Mortality Rate, Heart Failure Related Events, Quality of Life (QoL) and Healthcare Utilization Data at 6 Months and One Year Post Enrollment: Mortality Data	On each subject's final date of study participation, their survival status was recorded.	6 months and 1 year
Mortality Rate, Cause of Death, Quality of Life (QoL) and Healthcare Utilization Data at 6 Months and One Year Post Enrollment: Cause of Death	On each subject's final date of study participation, in the case of death, the cause of death was recorded.	6 months and 1 year
Mortality Rate, Heart Failure Related Events, Quality of Life (QoL) and Healthcare Utilization Data at 6 Months and One Year Post Enrollment: Quality of Life Data	At 0 months, 6 months, and 1 year after enrollment, subjects completed a Kansas City Cardiomyopathy Questionnaire (KCCQ-12). Quality of life is calculated as: KCCQ12-QL = 100*[(average of Questions 6 and 7) - 1]/4 Score is scaled 0-100, where 0 denotes the lowest reportable health status and 100 the highest.	6 months and 1 year
Mortality Rate, Heart Failure Related Events, Quality of Life (QoL) and Healthcare Utilization Data at 6 Months and One Year Post Enrollment: Healthcare Utilization Data	For each weekly phone call, monthly office visit, 6-month phone call, and 1-year phone call, each subject reported whether they experienced a hospitalization, emergency room visit, or unplanned doctor's office visit since their last call/visit.	6 months and 1 year

Collaborators and Investigators

• Sponsor: Zoll Medical Corporation
• Investigators: Study Director: Mike Osz, Zoll Medical Corporation

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): October 30, 2023

Study Registration Dates

• First Submitted: September 12, 2019
• First Submitted That Met QC Criteria: September 17, 2019
• First Posted (Actual): September 19, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: 90D0202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes