Heart FailureBMAD-TXNCT04096040
Benefits of Microcor in Ambulatory Decompensated Heart Failure
A study testing μCor in people with Heart Failure, run by Zoll Medical Corporation at 83 sites in 4 countries.
Trial summary
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. 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
- 265 participants
- Where
- 83 sitesin 4 countries
- Study dates
- 1 Nov 2019to 30 Oct 2023
- 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
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
83 sites in 4 countries.
83 sites in 4 countries
United States67 sites
North Texas Research Associates
Allen, Texas, 75013
Emory University School of Medicine
Atlanta, Georgia, 30303
Aventura Clinical Research LLC
Aventura, Florida, 33180
Sinai Center for Thrombosis Reserach and Drug Development
Baltimore, Maryland, 21784
Macklenberg Heart Specialists / Focus Clinical Research Solutions
Charlotte, North Carolina, 28207
Virtua Health
Cherry Hill, New Jersey, 08034
Columbus Cardiology Associates
Columbus, Georgia, 31904
Bassett Medical Center
Cooperstown, New York, 13326
North Houston Cardiology Center
Cypress, Texas, 77429
Accel Research Sites - Guardian
Davenport, Florida, 33837
Accel Research Sites- Daytona Heart Group
DeLand, Florida, 32720
Accel Research Sites - Guardian Winter Park
Deltona, Florida, 32725
Accel Research Sites - Lake County Medical Group
Eatonton, Georgia, 31024
TriWest Research
El Cajon, California, 92020
Holy Cross Hospital, Medical Group, Cardiology Associates
Fort Lauderdale, Florida, 33308
JPS Health Network
Fort Worth, Texas, 76104
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Heart Clinic of Hammond
Hammond, Louisiana, 70403
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Elite Cardiac Research Center
Hialeah, Florida, 33013
Inpatient Research Clinic
Hialeah, Florida, 33013
Zillan Clinical Research
Inglewood, California, 90301
Jackson Heart Clinic
Jackson, Mississippi, 48601
Knoxville HMA Cardiology, PPM, LLC
Knoxville, Tennessee, 37934
Carolina Heart Specialists
Lancaster, South Carolina, 77598
Kansas City Cardiology
Lee's Summit, Missouri, 64064
Bryan Heart
Lincoln, Nebraska, 68506
Axis Clinical Trials
Los Angeles, California, 90036
Norton Heart Specialists
Louisville, Kentucky, 40205
Stroobants Cardiovascular Center
Lynchburg, Virginia, 24501
North Texas Research Associates
McKinney, Texas, 75071
Texas Institute of Cardiology
McKinney, Texas, 75071
Homestead Associates in Research
Miami, Florida, 32032
Westchester Research Center at Westchester General Hospital
Miami, Florida, 33155
InvivoCure LLC
Mission Hills, California, 91345
Cardiovascular Research of Northwest Indiana, LLC
Munster, Indiana, 46321
Jersey Shore University Medical Center
Neptune City, New Jersey, 07753
Mission Research Institue
New Braunfels, Texas, 78130
Mercer Bucks Cardiology at Jefferson Health
Newtown, Pennsylvania, 18940
Miramax Clinical Research Inc
North Miami, Florida, 33169
Ocala Cardiovascular Research
Ocala, Florida, 34471
INTEGRIS Baptist Medical Center
Oklahoma City, Oklahoma, 73112
Methodist Physicians Clinical Heart Consultants
Omaha, Nebraska, 68114
Accel Research Sites
Orlando, Florida, 32837
Research Integrity, LLC
Owensboro, Kentucky, 42303
Intervent Clinical Research Center
Pembroke Hills, Maryland, 33024
Cardiovascular Institute
Pittsburgh, Pennsylvania, 15212
Pulse Heart Institute
Puyallup, Washington, 98372
Quincy Medical Group
Quincy, Illinois, 62301
Reid Physician Associates
Richmond, Indiana, 47374
Ascension Providence Rochester Hospital
Rochester, Michigan, 48307
Laurelton Heart Specialist
Rosedale, New York, 11422
Ascension St. Mary's Research Institute
Saginaw, Michigan, 48601
Peninsula Regional Medical Center
Salisbury, Maryland, 21804
ACRC Studies
San Diego, California, 92119
SYED Research Consultants LLC
Sheffield, Alabama, 35660
Frontier Clinical Research, LLC
Smithfield, Pennsylvania, 15478
Beacon Medical Group
South Bend, Indiana, 46601
Heart House Research Foundation
Springfield, Ohio, 45504
Gateway Cardiovascular Research Center, Inc
St Louis, Missouri, 63128
St. Louis Heart and Vascular
St Louis, Missouri, 63136
DBC Research
Tamarac, Florida, 33321
BronxCare Health System at BronxCare Hospital Center
The Bronx, New York, 10457
Mercy Health St. Vincent Medical Center
Toledo, Ohio, 43608
Bay Area Heart
Webster, Texas, 77598
Winter Haven Hospital - BayCare Health System
Winter Haven, Florida, 33880
Accel Research Sites - Guardian Winter Park
Winter Park, Florida, 32792
Germany9 sites
Kerckhoff-Klinik GmbH
Bad Nauheim, 06032
Kerckhoff-Klinik GmbH
Bad Nauheim
Universitätsklinikum Frankfurt
Frankfurt am Main, 60590
Universitätsklinikum Gießen und Marburg GmbH
Giessen, 35392
Albertinen Krankenhaus HH
Hamburg, GG, 22457
Albertinen Krankenhaus Hamburg
Hamburg
Medizinische Hochschule Hannover
Hanover, 30625
Medizinische Hochschule Hannover
Hanover
Herzzentrum Leipzig, Universitätsklinik für Kardiologie Abteilung Rhythmologie
Leipzig, 4289
France5 sites
Centre Hospitalier Régional Universitaire de Lille - Hôpital Cardiologique
Lille, 59037
CHU Montpellier - Hopital Arnaud de Villeneuve
Montpellier, 34295
Chu Montpellier - Hopital Arnaud de Villeneuve
Montpellier
Hôpital Européen Georges Pompidou - Centre d'Investigations Cliniques - Pôle D - étage 5
Paris, 75015
Hôpital Européen Georges Pompidou - Centre d'Investigations Cliniques - Pôle D - étage 5
Paris
Austria2 sites
Klinikum Klagenfurt am Wörthersee
Klagenfurt, 9020
Klinik Favoriten
Vienna, 1100
About this study
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.
Read the 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.
- 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
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.
| Study group | Role | What they receive |
|---|---|---|
| Device Data Engagement Assessment | Experimental | This arm will assess the endpoints of investigator engagement with the device data. Receives: Device: μCor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 90 days
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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].
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
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.
- First posted19 Sep 2019
- Study start1 Nov 2019
- Primary completion30 Jun 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 265 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zoll Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mike Osz, Study director, Zoll Medical Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04096040
- Sponsor's protocol ID
- 90D0202
- Acronym
- BMAD-TX
- Status last verified
- Dec 2024
- First submitted
- 12 Sep 2019
- Last updated
- 8 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of Microcor in Ambulatory Decompensated Heart Failure
- ClinicalTrials.gov ID
- NCT04096040
- Acronym / sponsor ID
- BMAD-TX / 90D0202
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 265 participants (actual)
- Lead sponsor
- Zoll Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 19 Sep 2019 (actual)
- Results
- Posted 9 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device Data Engagement Assessment | Experimental | Device: μCorThis arm will assess the endpoints of investigator engagement with the device data. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| μCorμCor 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. | Device | Device Data Engagement Assessment |
Primary outcome
Number of Data Updates Received by the uCor Subject Management System
Time frame: 90 days
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.
Approximate Time Spent Reviewing Data Reports Assessment Across Sites (PO 2: Part 1/2)
Time frame: 90 days
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.
Approximate Time Spent Reviewing Data Reports Assessment Within Sites (PO 2: Part 2/2)
Time frame: 90 days
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.
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)
Time frame: 90 days
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
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)
Time frame: 90 days
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.
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)
Time frame: 90 days
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
The Number of Medication Changes Based on Subject Incidental Findings
Time frame: 90 days
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.
Number of Times High μCor Measurements Were Reduced Below Threshold Levels After Medication Was Titrated or Lifestyle Modifications Were Recommended
Time frame: 90 days
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.
8 secondary outcomes
Strength of Association Between μCor Measurements and Clinically Related Heart Failure Events.
Time frame: 90 days
Strength of Association Between μCor Measurements and Subject Reported Symptoms
Time frame: 90 days
Correlations Between uCor Measurements and Patient Reported Symptoms: Mild/Severe Symptoms
Time frame: 90 days
Hospital Readmission Rate, Physician Visit Rate, and Outpatient Clinic Visit Rate During the Study Period
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 6 months and 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mike Osz study director
Zoll Medical Corporation
83 sites in 4 countries: see every site and its status.
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 83 sites in 4 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 3 inclusion and 11 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 83 sites in United States, Germany, France, 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 9 Oct 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?
Number of Data Updates Received by the uCor Subject Management System (time frame: 90 days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.