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Heart FailureBMADHFNCT03476187

Benefits of µCor in Ambulatory Decompensated Heart Failure

A study testing µCor in people with Heart Failure, run by Zoll Medical Corporation at 61 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Heart Failure
What is being tested?
µCor
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
257 participants
Where
61 sitesin 3 countries
Study dates
17 Aug 2018to 9 Apr 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

61 sites in 3 countries.

61 sites in 3 countries

United States57 sites

  • PharmaTex Research

    Amarillo, Texas, 79106

  • Fox Valley Clinical Research Center

    Aurora, Illinois, 60506

  • Grace Research LLC

    Bossier City, Louisiana, 71111

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Nova Clinical Research LLC

    Bradenton, Florida, 34209

  • Trinity Medical WNY

    Buffalo, New York, 14215

  • The Loretto Hospital

    Chicago, Illinois, 60644

  • Palmetto Health Advanced Heart Health Center

    Columbia, South Carolina, 29203

  • South Palm Cardiovascular Research Institute

    Delray Beach, Florida, 33446

  • UMPC Hamot

    Erie, Pennsylvania, 16550

  • Cardiology Institute of Michigan

    Flint, Michigan, 48507

  • Holy Cross Medical Group

    Fort Lauderdale, Florida, 33308

  • JPS Health Network

    Fort Worth, Texas, 76104

  • Texas Cardiovascular Institute

    Fort Worth, Texas, 76104

  • The Cardiac and Vascular Institute Research Foundation

    Gainesville, Florida, 32605

  • Nebraska Heart Institute

    Grand Island, Nebraska, 68803

  • East Carolina Heart Institute

    Greenville, North Carolina, 27834

  • Chicago Medical Research LLC

    Hazel Crest, Illinois, 60429

  • Northwest Houston Cardiology

    Houston, Texas, 77070

  • Marshall Cardiology

    Huntington, West Virginia, 25701

  • The Jackson Clinic, PA

    Jackson, Tennessee, 38301

  • Baptist Heart Specialists

    Jacksonville, Florida, 32250

  • NEA Baptist Clinic

    Jonesboro, Arkansas, 72405

  • Lancaster General Hospital

    Lancaster, Pennsylvania, 17602

  • The Heart Institute at Largo

    Largo, Florida, 33770

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102

  • Nebraska Heart Institute

    Lincoln, Nebraska, 68526

  • New Jersey Heart

    Linden, New Jersey, 07036

  • SJH Cardiology Associates

    Liverpool, New York, 13088

  • Cardiovascular Innovation and Research Center, Inc.

    Long Beach, California, 90813

  • Los Alamitos Cardiovascular

    Los Alamitos, California, 90720

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • CardioVogage

    McKinney, Texas, 75071

  • Texas Institute of Cardiology

    McKinney, Texas, 75071

  • Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Hennepen Healthcare Research Institute

    Minneapolis, Minnesota, 55415

  • Mobile Heart Specialists, PC

    Mobile, Alabama, 36608

  • University Hospital

    Mobile, Alabama, 36617

  • Clinical Trials of America, LLC

    Monroe, Louisiana, 71201

  • Riverside Hospital Inc.

    Newport News, Virginia, 23601

  • Cardiovascular Institute of Central Florida

    Ocala, Florida, 34471

  • OUHSC

    Oklahoma City, Oklahoma, 73104

  • Unity Point Health Cardiovascular Services

    Peoria, Illinois, 61606

  • AtlantiCare Regional Medical Center

    Pomona, New Jersey, 08240

  • NC Heart & Vascular Research

    Raleigh, North Carolina, 27607

  • Chippenham Hospital

    Richmond, Virginia, 23225

  • Henrico Doctors Hospital

    Richmond, Virginia, 23229

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • The Guthrie Clinic

    Sayre, Pennsylvania, 18840

  • Northside Hospital

    St. Petersburg, Florida, 33709

  • University of South Florida Dept of Cardiovascular Sciences

    Tampa, Florida, 33609

  • Cardiology Practice Tampa

    Tampa, Florida, 33613

  • Cardiovascular Consultants of South Georgia

    Thomasville, Georgia, 31792

  • Clinical Trials of America, LLC

    West Monroe, Louisiana, 71291

  • DuPage Medical Group

    Winfield, Illinois, 60190

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

  • Cardiology Consultants of Philadelphia

    Yardley, Pennsylvania, 19067

Other trials in United States

Germany3 sites

  • St. Vinzenz-Hospital; Akademisches Lehrkrankenhaus der Universität zu Köln, Innere Medizin III

    Cologne

  • Herzzentrum Leipzig GmbH

    Leipzig, 04289

  • Klinikum rechts der Isar - Technische Universität München, Klinik und Poliklinik für Innere Medizin I

    Munich

Other trials in Germany

Austria1 site

  • Universitätsklinik für Innere Medizin II, Abteilung für Kardiologie

    Vienna

Other trials in Austria

About this study

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.

Read the 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.

Conditions
Heart Failure
Being tested
µCor
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • µCorDevice

    Monitor with µCor

Study groups in NCT03476187
Study groupRoleWhat they receive
µCor wearersExperimentalWear the µCor device
Receives: Device: µCor

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Correlation of μCor Readings to Heart Failure Related Clinical Events

    HF Event: a hospitalization primarily due to heart failure within 90 days. Time window: The 7 days prior to the 1st heart failure hospitalization, or the final 7 days of device wear if no HF event occurred.

    Measured: 3 months

  2. Correlation of µCor Readings to Heart Failure Related Clinical 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 primarily due to heart failure

    Measured: 3 months

Secondary outcomes (10)

  1. Establishment of Rate of Occurrence of VT/VF Episodes and Arrhythmic Death in Subjects

    Rate of occurrence of VT/VF episodes at the time of enrollment in the study and rate of occurrence of arrhythmic death in subjects at 90 days and 1 year.

    Measured: Baseline, 90 days, 1 YR

  2. Correlation Between μCor Measurements and Subject Reported Symptoms - Area Under Curve

    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 (TFI), nighttime heart rate (HR), nighttime respiration rate (RR)]. Nighttime was defined as 12:00 AM - 7:00 AM.

    Measured: 3 months

  3. Correlation Between μCor Measurements and Subject Reported Symptoms - Number of 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]. Each day that the subject wore the device, a daily median was calculated for the following measures: [thoracic fluid index (TFI), nighttime heart rate (HR), nighttime respiration rate (RR)]. Nighttime was defined as 12:00 AM - 7:00 AM.

    Measured: 3 months

  4. Frequency of Subject Reported Symptoms

    During weekly phone calls and monthly office visits, subjects reported whether they experienced new arrhythmia and/or heart failure symptoms. Results indicate the number of times that subjects reported each of these two symptoms.

    Measured: 3 months

  5. Timing of Subject Reported Symptoms

    During weekly phone calls and monthly office visits, subjects reported whether they experienced new arrhythmia and/or heart failure symptoms. Results indicate the median number of weeks until a subject's first symptom report of each type.

    Measured: 3 months

  6. Severity of Subject Reported Symptoms

    Each subject was expected to undergo an in-person office visit at the site on months 0, 1, 2, and 3 in which they reported the severity of their heart failure symptoms. Results indicate the number of subjects reporting each severity level of each symptom at each office visit.

    Measured: 3 months

  7. Hospital Readmission Rate During the Study Period

    During weekly phone calls and monthly office visits, subjects reported whether they experienced a new hospitalization since their last call/visit. An adjudication committee of physicians determined whether each hospitalization was due to HF or not.

    Measured: 3 months

  8. Hospital Readmission Rate During Previous 90 Days Prior to Enrollment in Study

    At the time of enrollment, subjects reported how many hospitalizations they experienced in the 90 days prior to enrollment. Results indicate the number of subjects who reported a hospitalization in this time window.

    Measured: 3 months

  9. Hospital Readmission Rate During Previous 90 Days Prior to Enrollment in Study

    At the time of enrollment, subjects reported how many hospitalizations they experienced in the 90 days prior to enrollment. Results indicate the median number of hospitalizations reported per subject in this time window.

    Measured: 3 months

  10. Mortality, Heart Failure Related Events, and Health Care Utilization Data at Six Months and One Year Post Enrollment

    During weekly phone calls, monthly office visits, the 6-month phone call, and the 1-year phone call, subjects reported whether they experienced a hospitalization, ER visit, or unplanned doctor's office visit since the last call/visit. An adjudication committee of physicians determined whether each hospitalization was due to HF or not. On each subject's final date of study participation, their survival status was recorded.

    Measured: 6 months and 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2018
  2. Study start17 Aug 2018
  3. Primary completion8 Jan 2024
  4. Study completion9 Apr 2024

Resources

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
257 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03476187
Sponsor's protocol ID
90D0182
Acronym
BMADHF
Status last verified
Dec 2024
First submitted
19 Feb 2018
Last updated
8 Jan 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Boehmer JP, Cremer S, Abo-Auda WS, Stokes DR, Hadi A, McCann PJ, Burch AE, Bonderman D. Impact of a Novel Wearable Sensor on Heart Failure Rehospitalization: An Open-Label Concurrent-Control Clinical Trial. JACC Heart Fail. 2024 Dec;12(12):2011-2022. doi: 10.1016/j.jchf.2024.07.022. Epub 2024 Oct 9.

    PubMed 39387771

Questions about this trial

What is this clinical trial studying?

A study testing µCor in people with Heart Failure, run by Zoll Medical Corporation at 61 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 61 sites in United States, Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Correlation of μCor Readings to Heart Failure Related Clinical Events (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03476187, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2025.

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