Benefits of µCor in Ambulatory Decompensated Heart Failure (BMADHF)

Subjects meeting the inclusion/exclusion criteria will wear the µCor for at least 90 days. During the study, clinic follow up will occur every 30 days. For all subjects, each scheduled clinic visit will include assessment of cardiac symptoms and any relevant clinically actionable events. The subject will be given a daily diary to track symptoms, unplanned 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. 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 Overview

• Status: Active, not recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Device: µCor

Detailed Description

Subjects meeting the inclusion/exclusion criteria will wear µCor for 90 days from the day of fitting. 500 total patients will be enrolled. There will be an interim analysis when the 200th subject has finished the study in the study to assess for distribution of patients with reduced and preserved LVEF.

Subjects will be fitted with µCor during hospital discharge or within a clinic visit that has occurred within 10 days of a heart failure related hospitalization. The µCor fitting will mark day 0 of the study. An LVEF measurement will be recorded during enrollment or within 30 days post enrollment if an LVEF measurement has not been recorded within 30 days prior to enrollment. An investigator assessment will be performed during all clinic visits. The assessment template is shown in Appendix A.

Subjects will be given a diary at enrollment that will ask them to rate their degree of specific symptoms of heart failure such as shortness of breath and fatigue as well as mark any heart failure related clinical events or medication changes that have occurred since the last entry.

Study follow up visits will occur at day 30, day 60, and day 90. During follow up visits the subjects will be asked about any heart failure related clinical events or change in symptoms that have occurred since the last follow up. The subject will receive a study based weekly phone call asking the subject about any recent heart failure related clinical events or change in heart failure symptoms. During the weekly phone call the subject will be reminded to fill out the daily diary. No phone calls will be given on the week where there is a study follow up visit. There will be 9 total phone calls.

During the Day 90 visit, the subject will be given the option to continue wearing the µCor for an additional 90 days. Furthermore, if the subject experienced a heart failure related clinical event within the initial 90 days of wear, the subject will be given the option of wearing the µCor for 30 days following the heart failure event. .If the subject chooses additional wear time, weekly phone calls and monthly visits will be structured identical to that of the main study period. The µCor will be returned at end of use.

There will be a follow up at six months and one year post enrollment to document mortality data, heart failure related clinical events, and health care utilization data.

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria
    • Universitätsklinik für Innere Medizin II, Abteilung für Kardiologie
• Germany
  • Cologne, Germany
    • St. Vinzenz-Hospital; Akademisches Lehrkrankenhaus der Universität zu Köln, Innere Medizin III
  • Leipzig, Germany, 04289
    • Herzzentrum Leipzig GmbH
  • Munich, Germany
    • Klinikum rechts der Isar - Technische Universität München, Klinik und Poliklinik für Innere Medizin I
• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
      • Mobile Heart Specialists, PC
    • Mobile, Alabama, United States, 36617
      • University Hospital
  • Arkansas
    • Jonesboro, Arkansas, United States, 72405
      • NEA Baptist Clinic
  • California
    • Long Beach, California, United States, 90813
      • Cardiovascular Innovation and Research Center, Inc.
    • Los Alamitos, California, United States, 90720
      • Los Alamitos Cardiovascular
  • Florida
    • Bradenton, Florida, United States, 34209
      • Nova Clinical Research LLC
    • Delray Beach, Florida, United States, 33446
      • South Palm Cardiovascular Research Institute
    • Fort Lauderdale, Florida, United States, 33308
      • Holy Cross Medical Group
    • Gainesville, Florida, United States, 32605
      • The Cardiac and Vascular Institute Research Foundation
    • Jacksonville, Florida, United States, 32250
      • Baptist Heart Specialists
    • Largo, Florida, United States, 33770
      • The Heart Institute at Largo
    • Miami Beach, Florida, United States, 33140
      • Mount Sinai Medical Center
    • Ocala, Florida, United States, 34471
      • Cardiovascular Institute of Central Florida
    • Saint Petersburg, Florida, United States, 33709
      • Northside Hospital
    • Tampa, Florida, United States, 33609
      • University of South Florida Dept of Cardiovascular Sciences
    • Tampa, Florida, United States, 33613
      • Cardiology Practice Tampa
  • Georgia
    • Thomasville, Georgia, United States, 31792
      • Cardiovascular Consultants of South Georgia
  • Illinois
    • Aurora, Illinois, United States, 60506
      • Fox Valley Clinical Research Center
    • Chicago, Illinois, United States, 60644
      • The Loretto Hospital
    • Hazel Crest, Illinois, United States, 60429
      • Chicago Medical Research LLC
    • Maywood, Illinois, United States, 60153
      • Loyola University Medical Center
    • Peoria, Illinois, United States, 61606
      • Unity Point Health Cardiovascular Services
    • Winfield, Illinois, United States, 60190
      • DuPage Medical Group
  • Louisiana
    • Bossier City, Louisiana, United States, 71111
      • Grace Research Llc
    • Monroe, Louisiana, United States, 71201
      • Clinical Trials of America, LLC
    • West Monroe, Louisiana, United States, 71291
      • Clinical Trials of America, LLC
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Michigan
    • Flint, Michigan, United States, 48507
      • Cardiology Institute of Michigan
  • Minnesota
    • Minneapolis, Minnesota, United States, 55415
      • Hennepen Healthcare Research Institute
  • Nebraska
    • Grand Island, Nebraska, United States, 68803
      • Nebraska Heart Institute
    • Lincoln, Nebraska, United States, 68526
      • Nebraska Heart Institute
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • University Medical Center of Southern Nevada
  • New Jersey
    • Linden, New Jersey, United States, 07036
      • New Jersey Heart
    • Pomona, New Jersey, United States, 08240
      • Atlanticare Regional Medical Center
  • New York
    • Buffalo, New York, United States, 14215
      • Trinity Medical WNY
    • Liverpool, New York, United States, 13088
      • SJH Cardiology Associates
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center
  • North Carolina
    • Greenville, North Carolina, United States, 27834
      • East Carolina Heart Institute
    • Raleigh, North Carolina, United States, 27607
      • NC Heart & Vascular Research
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • OUHSC
  • Pennsylvania
    • Erie, Pennsylvania, United States, 16550
      • UMPC Hamot
    • Lancaster, Pennsylvania, United States, 17602
      • Lancaster General Hospital
    • Sayre, Pennsylvania, United States, 18840
      • The Guthrie Clinic
    • Yardley, Pennsylvania, United States, 19067
      • Cardiology Consultants of Philadelphia
  • South Carolina
    • Columbia, South Carolina, United States, 29203
      • Palmetto Health Advanced Heart Health Center
  • Tennessee
    • Jackson, Tennessee, United States, 38301
      • The Jackson Clinic, PA
  • Texas
    • Amarillo, Texas, United States, 79106
      • PharmaTex Research
    • Fort Worth, Texas, United States, 76104
      • JPS Health Network
    • Fort Worth, Texas, United States, 76104
      • Texas Cardiovascular Institute
    • Houston, Texas, United States, 77070
      • Northwest Houston Cardiology
    • McKinney, Texas, United States, 75071
      • Texas Institute of Cardiology
    • McKinney, Texas, United States, 75071
      • CardioVogage
  • Virginia
    • Newport News, Virginia, United States, 23601
      • Riverside Hospital Inc.
    • Richmond, Virginia, United States, 23225
      • Chippenham Hospital
    • Richmond, Virginia, United States, 23229
      • Henrico Doctors Hospital
  • West Virginia
    • Huntington, West Virginia, United States, 25701
      • Marshall Cardiology

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Subjects either hospitalized for decompensated systolic, diastolic, or combined heart failure or subjects presenting at an outpatient clinic with a history of hospital discharge for decompensated systolic, diastolic, or combined heart failure within the previous 10 days.
• All subjects must be 21 years of age or older on the day of screening.

Exclusion Criteria:

• Subjects who are wearing the wearable cardioverter defibrillator (WCD)
• Subjects not expected to survive one year from enrollment from non-cardiac disease.
• Subjects with skin allergy or sensitivity to medical adhesives.
• Subjects anticipated to start dialysis within 90 days.
• Subjects currently implanted with an S-ICD system.
• Subjects whose primary diagnosis on hospital admission was Acute Coronary Syndrome (ACS) STEMI/NSTEMI rather than heart failure exacerbation.
• Subjects who are unable to participate in all follow up visits.
• Subjects participating in any other research at time of enrollment.
• Subjects currently implanted with an LVAD.

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: µCor wearers; Wear the µCor device	Device: µCor; Monitor with µCor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of µCor measured thoracic fluid index to heart failure related clinical events	Reading include: thoracic fluid index.	3-6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of cardiac rhythm µCor measurements to heart failure related clinical events	Readings include: cardiac rhythm	3-6 months
Correlation of respiration rate µCor measurements to heart failure related clinical events	Readings include: respiration rate	3-6 months
Correlation of posture µCor measurements to heart failure related clinical events	Readings include: posture	3-6 months
Correlation of physical activity µCor measurements to heart failure related clinical events	Readings include: physical activity	3-6 months
Correlation of hospitalizations µCor measurements to heart failure related clinical events	Readings include: hospitalizations	3-6 months
Correlation of medication changes µCor measurements to heart failure related clinical events	Readings include: medication changes	3-6 months
Correlation of symptom changes µCor measurements to heart failure related clinical events	Readings include: symptom changes	3-6 months

Collaborators and Investigators

• Sponsor: Zoll Medical Corporation
• Investigators: Study Director: Steven J. Szymkiewicz, MD, Zoll Medical Corporation

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2018
• Primary Completion (Estimated): July 31, 2023
• Study Completion (Estimated): July 31, 2023

Study Registration Dates

• First Submitted: February 19, 2018
• First Submitted That Met QC Criteria: March 15, 2018
• First Posted (Actual): March 23, 2018

Study Record Updates

• Last Update Posted (Actual): July 12, 2023
• Last Update Submitted That Met QC Criteria: July 11, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 90D0182

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