Benefits of Microcor in Ambulatory Decompensated Heart Failure

Not Applicable

Completed

Conditions: Heart Failure

Registration Number: NCT04096040

Lead Sponsor: Zoll Medical Corporation

Brief 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 265

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Approximate Time Spent Reviewing Data Reports Assessment Across Sites (PO 2: Part 1/2)	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)	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)	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)	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)	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
Number of Data Updates Received by the uCor Subject Management System	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.
The Number of Medication Changes Based on Subject Incidental Findings	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	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.

Secondary Outcome Measures

Name	Time	Method
Strength of Association Between μCor Measurements and Clinically Related Heart Failure Events.	90 days	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.
Strength of Association Between μCor Measurements and Subject Reported Symptoms	90 days	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.
Hospital Readmission Rate, Physician Visit Rate, and Outpatient Clinic Visit Rate During the Study Period	90 days	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.
Mortality Rate, Heart Failure Related Events, Quality of Life (QoL) and Healthcare Utilization Data at 6 Months and One Year Post Enrollment: Mortality Data	6 months and 1 year	On each subject's final date of study participation, their survival status was recorded.
Mortality Rate, Cause of Death, Quality of Life (QoL) and Healthcare Utilization Data at 6 Months and One Year Post Enrollment: Cause of Death	6 months and 1 year	On each subject's final date of study participation, in the case of death, the cause of death was recorded.
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	6 months and 1 year	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.
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	6 months and 1 year	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.
Correlations Between uCor Measurements and Patient Reported Symptoms: Mild/Severe Symptoms	90 days	During office visits at months 1, 2, and 3, subjects reported their degrees of dyspnea, orthopnea, and fatigue on the following scale: \[none, seldom, frequent, continuous\].

Trial Locations

Locations (78): SYED Research Consultants LLC
🇺🇸
Sheffield, Alabama, United States
TriWest Research
🇺🇸
El Cajon, California, United States
Zillan Clinical Research
🇺🇸
Inglewood, California, United States
Axis Clinical Trials
🇺🇸
Los Angeles, California, United States
InvivoCure LLC
🇺🇸
Mission Hills, California, United States
ACRC Studies
🇺🇸
San Diego, California, United States
Aventura Clinical Research LLC
🇺🇸
Aventura, Florida, United States
Accel Research Sites - Guardian
🇺🇸
Davenport, Florida, United States
Accel Research Sites- Daytona Heart Group
🇺🇸
DeLand, Florida, United States
Accel Research Sites - Guardian Winter Park
🇺🇸
Winter Park, Florida, United States
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SYED Research Consultants LLC
🇺🇸Sheffield, Alabama, United States